[{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse', 'Brief Summary': 'The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': 'The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).', 'Inclusion Criteria': 'Inclusion Criteria: Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Women must agree to follow methods of contraception, if applicable', 'Exclusion Criteria': 'Exclusion Criteria: Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation History of allergy or hypersensitivity to study drug components Participants with a condition requiring systemic treatment with corticosteroids Participants who have received a live\/attenuated vaccine within 30 days of first treatment'}","output":"{'Arm - Disease - Biomarker': 'Exclude: PD-1, PD-L1, PD-L2, CTLA-4'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse', 'Brief Summary': 'The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': 'The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).', 'Inclusion Criteria': 'Inclusion Criteria: Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Women must agree to follow methods of contraception, if applicable', 'Exclusion Criteria': 'Exclusion Criteria: Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation History of allergy or hypersensitivity to study drug components Participants with a condition requiring systemic treatment with corticosteroids Participants who have received a live\/attenuated vaccine within 30 days of first treatment'}","output":"{'Arm - Disease - Biomarker': 'Exclude: PD-1, PD-L1, PD-L2, CTLA-4'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse', 'Brief Summary': 'The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': 'The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).', 'Inclusion Criteria': 'Inclusion Criteria: Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Women must agree to follow methods of contraception, if applicable', 'Exclusion Criteria': 'Exclusion Criteria: Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation History of allergy or hypersensitivity to study drug components Participants with a condition requiring systemic treatment with corticosteroids Participants who have received a live\/attenuated vaccine within 30 days of first treatment'}","output":"{'Arm - Disease - Biomarker': 'Exclude: PD-1, PD-L1, PD-L2, CTLA-4'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse', 'Brief Summary': 'The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': 'The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).', 'Inclusion Criteria': 'Inclusion Criteria: Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Women must agree to follow methods of contraception, if applicable', 'Exclusion Criteria': 'Exclusion Criteria: Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation History of allergy or hypersensitivity to study drug components Participants with a condition requiring systemic treatment with corticosteroids Participants who have received a live\/attenuated vaccine within 30 days of first treatment'}","output":"{'Arm - Disease - Biomarker': 'Exclude: PD-1, PD-L1, PD-L2, CTLA-4'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse', 'Brief Summary': 'The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': 'The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).', 'Inclusion Criteria': 'Inclusion Criteria: Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Women must agree to follow methods of contraception, if applicable', 'Exclusion Criteria': 'Exclusion Criteria: Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation History of allergy or hypersensitivity to study drug components Participants with a condition requiring systemic treatment with corticosteroids Participants who have received a live\/attenuated vaccine within 30 days of first treatment'}","output":"{'Arm - Disease - Biomarker': 'Exclude: PD-1, PD-L1, PD-L2, CTLA-4'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+\/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive\/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer Advanced Breast Cancer Hormone Receptor Positive Tumor Human Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age \u2265 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': \"Inclusion Criteria: Female patients over 18 years of age. Pre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria: Age \u226560 years; Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\/or FSH level within the laboratory's reference range for postmenopausal females; Documented bilateral oophorectomy. Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1. Life expectancy greater or equal to 12 weeks. Histologically proven diagnosed of ABC not amenable to curative treatment. Documented recurrent ER-positive and\/or progesterone receptor (PgR)-positive (with \u22651% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting. Radiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded. Patients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease \u2265 24 weeks or partial or complete response confirmed or unconfirmed). Patients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen. Last dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting. Patients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI. Patients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible. Willingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee. Patients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination. Adequate organ function: (Hematological, hepatic and renal) Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities. Resolution of all acute toxic effects of prior anti-cancer therapy to grade 1\", 'Exclusion Criteria': 'Exclusion Criteria: HR or HER2 unknown disease. HER2-positive disease based on local laboratory results (performed by IHC \/ ISH test). Locally ABC candidate for curative treatment. Formal contraindication to endocrine therapy defined as visceral crisis and rapidly or symptomatic progressive visceral disease. Prior therapy with any other CDK4\/6 inhibitor different from palbociclib. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. Patients are currently receiving food or drugs known to be strong inducers or inhibitors of CYP3A4. Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively- treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ, among others, are generally eligible. No other systemic therapy for metastatic disease including chemotherapy, immunotherapy, targeted therapy (small molecules\/ monoclonal antibodies), or endocrine therapy excluding first-line palbociclib-based regimen. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 2 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study. Radiotherapy or limited-field palliative radiotherapy within 7 days prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade \u2264 1 and\/or from whom \u2265 25% of the bone marrow has been previously irradiated. Use of concurrent investigational agents or other concomitant anticancer therapies. Active bleeding diathesis, previous history of bleeding diathesis, or chronic anti-coagulation treatment (the use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention). Serious concomitant systemic disorder (e.g., active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator). Unable to swallow capsules or tablets. History of malabsorption syndrome or other condition that would interfere with enteral absorption. Any of the following within 6 months of randomization: myocardial infarction, severe\/unstable angina, ongoing cardiac dysrhythmias of NCI-CTCAE v.5.0 grade \u22652, coronary\/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. Uncontrolled electrolyte disorders of NCI-CTCAE v.5.0 grade \u2265 2. Known hypersensitivity to palbociclib or any of its excipients.'}","output":"{'Arm - Disease - Biomarker': 'Include: HR+, HER2- Exclude: HER2+'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+\/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive\/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer Advanced Breast Cancer Hormone Receptor Positive Tumor Human Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age \u2265 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': \"Inclusion Criteria: Female patients over 18 years of age. Pre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria: Age \u226560 years; Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\/or FSH level within the laboratory's reference range for postmenopausal females; Documented bilateral oophorectomy. Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1. Life expectancy greater or equal to 12 weeks. Histologically proven diagnosed of ABC not amenable to curative treatment. Documented recurrent ER-positive and\/or progesterone receptor (PgR)-positive (with \u22651% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting. Radiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded. Patients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease \u2265 24 weeks or partial or complete response confirmed or unconfirmed). Patients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen. Last dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting. Patients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI. Patients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible. Willingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee. Patients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination. Adequate organ function: (Hematological, hepatic and renal) Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities. Resolution of all acute toxic effects of prior anti-cancer therapy to grade 1\", 'Exclusion Criteria': 'Exclusion Criteria: HR or HER2 unknown disease. HER2-positive disease based on local laboratory results (performed by IHC \/ ISH test). Locally ABC candidate for curative treatment. Formal contraindication to endocrine therapy defined as visceral crisis and rapidly or symptomatic progressive visceral disease. Prior therapy with any other CDK4\/6 inhibitor different from palbociclib. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. Patients are currently receiving food or drugs known to be strong inducers or inhibitors of CYP3A4. Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively- treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ, among others, are generally eligible. No other systemic therapy for metastatic disease including chemotherapy, immunotherapy, targeted therapy (small molecules\/ monoclonal antibodies), or endocrine therapy excluding first-line palbociclib-based regimen. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 2 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study. Radiotherapy or limited-field palliative radiotherapy within 7 days prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade \u2264 1 and\/or from whom \u2265 25% of the bone marrow has been previously irradiated. Use of concurrent investigational agents or other concomitant anticancer therapies. Active bleeding diathesis, previous history of bleeding diathesis, or chronic anti-coagulation treatment (the use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention). Serious concomitant systemic disorder (e.g., active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator). Unable to swallow capsules or tablets. History of malabsorption syndrome or other condition that would interfere with enteral absorption. Any of the following within 6 months of randomization: myocardial infarction, severe\/unstable angina, ongoing cardiac dysrhythmias of NCI-CTCAE v.5.0 grade \u22652, coronary\/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. Uncontrolled electrolyte disorders of NCI-CTCAE v.5.0 grade \u2265 2. Known hypersensitivity to palbociclib or any of its excipients.'}","output":"{'Arm - Disease - Biomarker': 'Include: HR+, HER2- Exclude: HER2+'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA\u00ae) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO\u00ae] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC. Documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R. Investigator-determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib\/afatinib\/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib\/afatinib\/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status. Note: TKI washout period for all participants is 1 week or 2 half-lives after last treatment dose, whichever is longer. TKI washout should be completed prior to first dose of study treatment. Measurable disease per RECIST 1.1 as assessed by the local site investigator\/radiology. Provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since biopsy) core or excisional biopsy of a tumor lesion not previously irradiated. Life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment but before randomization. Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents. Female participants must not be pregnant, not breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents. Adequate organ function.', 'Exclusion Criteria': 'Exclusion Criteria: Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. Symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. Received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137). Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and\/or radiation as part of neoadjuvant\/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.] Received prior radiotherapy within 2 weeks of start of study treatment or has received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\u22642 weeks of radiotherapy) to non-central nervous system (CNS) disease. Received a live vaccine within 30 days prior to the first dose of study treatment. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. Known additional malignancy that is progressing or has required active treatment within the past 5 years. (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.) Known active untreated CNS metastases and\/or carcinomatous meningitis. Severe hypersensitivity (\u2265 Grade 3) to pembrolizumab and\/or any of its excipients. Known sensitivity to any component of cisplatin, carboplatin, or pemetrexed. Active autoimmune disease that has required systemic treatment in past 2 years. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Active infection requiring systemic therapy. Known history of human immunodeficiency virus (HIV) infection. Known history of Hepatitis B or known active Hepatitis C virus. Known history of active tuberculosis (TB; Bacillus tuberculosis) Pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents.'}","output":"{'Arm - Disease - Biomarker': 'Include: EGFR mutation, specifically either DEL19 or L858R, confirmed acquired T790M mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA\u00ae) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO\u00ae] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC. Documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R. Investigator-determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib\/afatinib\/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib\/afatinib\/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status. Note: TKI washout period for all participants is 1 week or 2 half-lives after last treatment dose, whichever is longer. TKI washout should be completed prior to first dose of study treatment. Measurable disease per RECIST 1.1 as assessed by the local site investigator\/radiology. Provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since biopsy) core or excisional biopsy of a tumor lesion not previously irradiated. Life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment but before randomization. Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents. Female participants must not be pregnant, not breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents. Adequate organ function.', 'Exclusion Criteria': 'Exclusion Criteria: Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. Symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. Received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40, CD137). Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and\/or radiation as part of neoadjuvant\/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.] Received prior radiotherapy within 2 weeks of start of study treatment or has received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\u22642 weeks of radiotherapy) to non-central nervous system (CNS) disease. Received a live vaccine within 30 days prior to the first dose of study treatment. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. Known additional malignancy that is progressing or has required active treatment within the past 5 years. (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.) Known active untreated CNS metastases and\/or carcinomatous meningitis. Severe hypersensitivity (\u2265 Grade 3) to pembrolizumab and\/or any of its excipients. Known sensitivity to any component of cisplatin, carboplatin, or pemetrexed. Active autoimmune disease that has required systemic treatment in past 2 years. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Active infection requiring systemic therapy. Known history of human immunodeficiency virus (HIV) infection. Known history of Hepatitis B or known active Hepatitis C virus. Known history of active tuberculosis (TB; Bacillus tuberculosis) Pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents.'}","output":"{'Arm - Disease - Biomarker': 'Include: EGFR mutation, specifically either DEL19 or L858R, confirmed acquired T790M mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer', 'Brief Summary': 'The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.', 'Condition': 'Urothelial Carcinoma', 'Detailed Description': 'This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and\/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or locally advanced urothelial cancer Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL\/min) to receive carboplatin and >60 mL\/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (\u02c2) 60 mL\/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2 Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant\/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant\/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed Active malignancies requiring concurrent therapy other than urothelial cancer Symptomatic central nervous system metastases'}","output":"{'Arm - Disease - Biomarker': 'Include: Fibroblast growth factor receptor (FGFR) gene alterations '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer', 'Brief Summary': 'The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.', 'Condition': 'Urothelial Carcinoma', 'Detailed Description': 'This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and\/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or locally advanced urothelial cancer Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL\/min) to receive carboplatin and >60 mL\/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (\u02c2) 60 mL\/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2 Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant\/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant\/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed Active malignancies requiring concurrent therapy other than urothelial cancer Symptomatic central nervous system metastases'}","output":"{'Arm - Disease - Biomarker': 'Include: Fibroblast growth factor receptor (FGFR) gene alterations '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II Study to Evaluate Neoadjuvant Osimertinib Therapy in Patients With Surgically Resectable, EGFR-Mutant Non-Small Cell Lung Cancer', 'Brief Summary': 'This phase II trial studies how well osimertinib works in treating participants with stage I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before surgery. Osimertinib may stop the growth of tumor cells by blocking mutant EGFR signaling in cancer cells.', 'Condition': 'Stage I Non-Small Cell Lung Cancer Stage IA Non-Small Cell Lung Cancer Stage IB Non-Small Cell Lung Cancer Stage II Non-Small Cell Lung Cancer Stage IIA Non-Small Cell Lung Cancer Stage IIB Non-Small Cell Lung Cancer Stage IIIA Non-Small Cell Lung Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To evaluate the efficacy of osimertinib as neoadjuvant therapy in patients with surgically resectable EGFR-mutant non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate the safety of osimertinib given as neoadjuvant therapy in early stage EGFR-mutant NSCLC participants. II. To evaluate whether neoadjuvant osimertinib treatment increases the frequency of tumors that are unresectable due to adverse events or disease progression. III. To evaluate secondary measures of clinical efficacy in early stage EGFR-mutant NSCLC patients treated with osimertinib induction therapy. TERTIARY OBJECTIVES: I. To evaluate long-term measures of efficacy in patients treated with osimertinib neoadjuvant therapy. II. To explore tissue and cell-free biomarkers that may be predictive of response or primary resistance to osimertinib neoadjuvant therapy. OUTLINE: Participants receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection of their cancer. After completion of study treatment, participants are followed up at 30 days then every 3 months for up to 1 year.', 'Inclusion Criteria': \"Inclusion Criteria: Males and females >=18 years of age Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), performed on a biopsy that occurred within the last 90 days. This biopsy can be deferred if the procedure is deemed to represent an unacceptable safety risk to the patient by the Principal Investigator and as long as the patient has a prior biopsy showing non-small cell lung cancer. Documented activating EGFR mutation (Exon 19 deletion, T790M, or L858R) on tumor samples by Clinical Laboratory Clinical Laboratory Improvement Amendments (CLIA)-approved test Patients treated with osimertinib or another EGFR tyrosine kinase inhibitors (TKI) (including erlotinib, afatinib, gefitinib, & rocelitinib) are eligible if they received no more than 28 days of treatment, and if there is no evidence of grade 2 or greater treatment adverse events possibly related to treatment with the EGFR TKI. Positron emission tomography (PET)-computed tomography (CT) within the last 60 days showing radiographic stage I to IIIa lung cancer (mediastinal staging biopsy is allowed but not required) Brain magnetic resonance imaging (MRI) (or CT if contraindication to MRI) within the last 60 days showing no evidence of metastatic disease Documentation that the patient is a candidate for surgical resection of their lung cancer by an American Board of Thoracic Surgery certified surgeon The patient must have a tumor size >=1 centimeter (cm) in its longest diameter. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinumtherapy-related neuropathy is allowed Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) Bilirubin =< 1.5 x ULN, (Patients with documented Gilbert's syndrome and conjugated bilirubin within the normal range may be allowed into the study; in this event, it will be documented that the patient was eligible based on conjugated bilirubin levels) Potassium and magnesium within normal range, patients may receive supplements to meet this requirement Leukocytes > 3,000\/microliter (mcL) Hemoglobin >= 9 g\/dL, with no blood transfusions in the 28 days prior to study entry Absolute neutrophil count > 1,500\/mcL Platelets > 100,000\/mcL Creatinine Clearance (CrCl) > 50 mL\/min for patients with serum creatinine (SCr) > 1.5 x upper limit of normal (ULN) Ability to swallow oral medications Women of childbearing potential (WoCBP) must have a negative serum pregnancy test within 3 days prior to the first dose of study treatment and agree to use highly effective contraception, during the study and for 90 days following the last dose of osimertinib Women of childbearing potential (WoCBP): women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal Permanent sterilization includes hysterectomy and\/or bilateral oophorectomy and\/or bilateral salpingectomy but excludes bilateral tubal occlusion; tubal occlusion is considered a highly effective method of birth control but does not absolutely exclude possibility of pregnancy; (the term occlusion refers to both occluding and ligating techniques that do not physically remove the oviducts) Women who have undergone tubal occlusion should be managed on trials as if they are of WoCBP (e.g. undergo pregnancy testing etc., as required by the study protocol) Women will be considered postmenopausal if they are amenorrhoeic for 12 months without an alternative medical cause; the following age-specific requirements apply: Women under 50 years old will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range Women over 50 years of age will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments Acceptable contraception methods are: Total sexual abstinence (abstinence must be for the total duration of the trial and the follow-up period) Vasectomized sexual partner plus male condom (with participant assurance that partner received post-vasectomy confirmation of azoospermia) Tubal occlusion plus male condom Intra-uterine device - provided coils are copper-banded, plus male condom Intra-uterine system (IUS) levonorgestrel IUS (e.g., Mirena), plus male condom Medroxyprogesterone injections (Depo-Provera) plus male condom Etonogestrel implants (e.g., Implanon, Norplan) plus male condom Normal and low dose combined oral contraceptive pills, plus male condom Norelgestromin \/ ethinylestradiol transdermal system plus male condom Intravaginal device (e.g., ethinylestradiol and etonogestrel) plus male condom Cerazette (desogestrel) plus male condom (Cerazette is currently the only highly efficacious progesterone based pill) Unacceptable Contraception Methods The following methods are considered not to be highly effective and are therefore not acceptable contraceptive methods: Triphasic combined oral contraceptives All progesterone only pills except, Cerazette All barrier methods, if intended to be used alone Non-copper containing intra-uterine devices Fertility awareness methods Coitus interruptus Men with a female partner of childbearing potential must have either had a prior vasectomy agree to use effective contraception as described in the full protocol for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 90 days following the last dose of osimertinib\", 'Exclusion Criteria': 'Exclusion Criteria: Leptomeningeal carcinomatosis or other central nervous system (CNS) metastases Stage IIIB, or distant metastases (including malignant pleural effusion) identified on PET-CT scan or biopsy (PET abnormalities that are negative for malignancy on biopsy will be considered on a case by case basis Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease Patients who are known to be serologically positive for human immunodeficiency virus (HIV) Active second malignancy, i.e. patient known to have potentially fatal cancer present for which he\/she may be (but not necessarily) currently receiving treatment; patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy for prior malignancy was completed > 12 months prior and\/or bone marrow transplant > 2 years prior Patients who are currently receiving treatment with contraindicated corrected QT interval (QTc) prolonging medications or potent CYP3A4 inducers, if that treatment cannot be either discontinued or switched to a different medication prior to first day of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and\/or ingestion of foods with known inducer effects Any of the following cardiac abnormalities or history: Mean resting corrected QT interval (QTc) > 470 msec, obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval Treatment with prohibited medications (concurrent anticancer therapy including chemotherapy, radiation, hormonal treatment [except corticosteroids and megesterolacetate], or immunotherapy) =< 14 days prior to treatment with osimertinib Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator?s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or known active infection including chronic active hepatitis B, hepatitis C and human immunodeficiency virus (HIV); screening for chronic conditions is not required; patients with chronic hepatitis B virus (HBV) with negative HBV viral load on appropriate antiviral therapy will be permitted, if able to continue appropriate antiviral therapy throughout treatment period Active tuberculosis Signs or symptoms of infection within 2 weeks prior to first day of study Therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to first day of study treatment: Patients receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible Class II to IV heart failure as defined by the New York Heart Association functional classification system Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction (LVEF) < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate, to be eligible Patients who have experienced untreated and\/or uncontrolled cardiovascular conditions and\/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous 3 months; coronary angioplasty, or stenting or bypass grafting within the past 6 months; cardiac ventricular arrhythmias requiring medication; any history of second (2nd) or third (3rd) degree atrioventricular conduction defects) Females who are pregnant or breastfeeding Presence of active gastrointestinal (GI) disease (including GI bleeding or ulceration) or other condition that could affect GI absorption (e.g. malabsorption syndrome, history of biliary tract disease), including refractory nausea or vomiting, or chronic GI disease which may affect absorption or tolerance to oral medications History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib Involvement in the planning and\/or conduct of the study (applies to both investigator staff and\/or staff at the study site) Participation in another clinical study with an investigational product during the last 2 months or within five half-lives of the compound, whichever is longer Uncontrolled medical, psychological, familial, sociological, or geographical conditions that interfere with the patient?s safety, ability to provide informed consent, or ability to comply with the protocol'}","output":"{'Arm - Disease - Biomarker': 'Include: EGFR mutation (Exon 19 deletion, T790M, or L858R) on tumor samples'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer', 'Brief Summary': 'The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.', 'Condition': 'Breast Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Women (regardless of menopausal status) or men \u226518 years of age (or per local regulations). The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases. The participant must have undergone definitive surgery of the primary breast tumor. The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization. Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: 4 or more positive axillary lymph nodes Tumor size of at least 5 centimeters Grade 3 defined as at least 8 points on the Bloom Richardson grading system Ki-67 index by central analysis of \u226520% on untreated breast tissue The participant must be randomized within 16 months from the time of definitive breast cancer surgery. The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last. Participants must have recovered (grade \u22641) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery. Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods. The participant has a Eastern Cooperative Oncology Group (ECOG) performance status \u22641. The participant has adequate organ function. The participant is able to swallow oral medications.', 'Exclusion Criteria': 'Exclusion Criteria: Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease. Participants with inflammatory breast cancer. Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone \u22655 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded. Females who are pregnant or lactating. The participant has previously received treatment with any CDK4 and CDK6 inhibitor. The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate). The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene. The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE). The participant has active systemic infections or viral load. The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.'}","output":"{'Arm - Disease - Biomarker': 'Include: HR-Positive, HER2-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer', 'Brief Summary': 'The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.', 'Condition': 'Breast Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Women (regardless of menopausal status) or men \u226518 years of age (or per local regulations). The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases. The participant must have undergone definitive surgery of the primary breast tumor. The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization. Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: 4 or more positive axillary lymph nodes Tumor size of at least 5 centimeters Grade 3 defined as at least 8 points on the Bloom Richardson grading system Ki-67 index by central analysis of \u226520% on untreated breast tissue The participant must be randomized within 16 months from the time of definitive breast cancer surgery. The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last. Participants must have recovered (grade \u22641) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery. Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods. The participant has a Eastern Cooperative Oncology Group (ECOG) performance status \u22641. The participant has adequate organ function. The participant is able to swallow oral medications.', 'Exclusion Criteria': 'Exclusion Criteria: Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease. Participants with inflammatory breast cancer. Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone \u22655 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded. Females who are pregnant or lactating. The participant has previously received treatment with any CDK4 and CDK6 inhibitor. The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate). The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene. The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE). The participant has active systemic infections or viral load. The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.'}","output":"{'Arm - Disease - Biomarker': 'Include: HR-Positive, HER2-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer', 'Brief Summary': 'This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 in patients with locally advanced or metastatic breast cancer (MBC).', 'Condition': 'Metastatic Breast Cancer Locally Advanced Breast Cancer', 'Detailed Description': 'U3-1302 is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This study is a phase II study of U3-1402 in subjects with MBC who have received no prior anti HER2 therapy. The study will be conducted in 3 parts (Part A, Part B, and Part Z). All enrolled subjects in part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER\/PR\/HER2\/HER3) show preliminary efficacy after an analysis is performed at 24 weeks. Part B will enroll subgroups of subjects that will be defined from part A based on ER\/PR\/HER2\/HER3 expression and will be evaluated for efficacy analysis. Part Z will enroll additional 21 subjects with HER2+ MBC.', 'Inclusion Criteria': \"Inclusion Criteria: Patients must meet the following criteria in order to be included in the research study: Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses Women and men at least 18 years-of-age at the time of signature of the informed consent form (ICF) Histologically documented locally advanced or metastatic breast cancer Triple-negative breast cancer patients should have received at least 1 but no more than 3 prior lines of chemotherapy in the metastatic setting Parts A and B (HER2-negative, ER-positive) patients only: HR+ breast cancer patients should have received prior treatment with endocrine therapy +CDK 4\/6 inhibitor. No limit to prior endocrine therapy regimens but no more than 2 prior chemotherapy regimens in the metastatic setting Part Z patients only should have documented HER2-positive expression as per American Society of Clinical Oncology - College of American Pathologists guidelines based on local testing. Part Z patients only should have had prior treatment with at least 2 anti-HER2 therapies, 1 of which must be T-DXd. These patients must have experienced disease progression after receiving T-DXd. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (bone-only disease excluded) Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed \u22654 weeks prior to initiation of study treatment (2 weeks for patients who received palliative radiation therapy), there is no evidence of central nervous system disease progression on a scan or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy for the treatment of brain metastases Willingness to undergo pre-treatment biopsy and on-treatment biopsies. Must have a tumor amenable to pre-treatment biopsy (unless archived tissue is available and was obtained within 2 months prior to starting treatment) and on-treatment biopsy (excludes bone lesions and previously irradiated lesions). Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Has adequate organ function within 7 days before the start of study treatment, defined as: Platelet count \u2265100 \u00d7 10^9\/L Hemoglobin (Hb) \u22659 g\/dL (transfusion and\/or growth factor support allowed) Absolute neutrophil count \u22651.5 \u00d7 10^9\/L Prothrombin time (PT) and partial thromboplastin time (PTT) \u22641.5 \u00d7 the upper limit of normal (ULN), except for patients on coumadin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-international normalized ratio (INR) within therapeutic range as deemed appropriate by the Investigator. Serum creatinine \u22641.5 \u00d7 ULN, or creatinine clearance \u2265 50 mL\/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 \u00d7 ULN. AST\/ALT \u22643 \u00d7 ULN (if liver metastases are present, \u22645 \u00d7 ULN) Total bilirubin \u22641.5 \u00d7 ULN if no liver metastases or < 3 \u00d7 ULN in the presence of documented Gilbert's syndrome or liver metastases Serum albumin \u2265 2.5 g\/dL Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for at least 7 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.\", 'Exclusion Criteria': \"Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry: Exclusion criteria for Part A and B (HER2-negative) and Part Z (HER2-positive) cohorts: Treatment with any of the following: Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of U3-1402. Prior treatment with any HER3 targeting agent Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment Chloroquine \/hydroxychloroquine \u226414 days prior to the first dose of study drug treatment. Has any hypersensitivity to drug substances or inactive ingredients in drug product. Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation. Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sj\u00f6gren's syndrome, sarcoidosis) OR prior pneumonectomy With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor. Leptomeningeal metastases or spinal cord compression due to disease Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment Any of the following cardiac criteria currently or within the last 6 months: Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block Congestive heart failure (New York Heart Association \u2265 Grade 2 [Appendix D]) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age Patients with a left ventricular ejection fraction (LVEF) <50% Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\/or follow-up procedures outlined in the protocol. Additional exclusion criteria only for Part A and B (HER2-negative) cohorts: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., T-DXd, DS-1062a, and DS-7300a) Patients with HER2+ breast cancer per ASCO-CAP guidelines Additional exclusion criteria only for Part Z (HER2-positive) cohort: Treatment with any of the following: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor except T-DXd Prior treatment with T-DXd within 4 weeks prior to the first dose of U3-1402 Uncontrolled or significant cardiovascular disease, including history of myocardial infarction within 6 months before enrollment A severe reaction or severe tolerability issues that necessitated stopping treatment with T-DXd Any unresolved toxicities from prior therapy with T-DXd.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Negative, HR-Positive Exclude: HER2-positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer', 'Brief Summary': 'This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 in patients with locally advanced or metastatic breast cancer (MBC).', 'Condition': 'Metastatic Breast Cancer Locally Advanced Breast Cancer', 'Detailed Description': 'U3-1302 is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This study is a phase II study of U3-1402 in subjects with MBC who have received no prior anti HER2 therapy. The study will be conducted in 3 parts (Part A, Part B, and Part Z). All enrolled subjects in part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER\/PR\/HER2\/HER3) show preliminary efficacy after an analysis is performed at 24 weeks. Part B will enroll subgroups of subjects that will be defined from part A based on ER\/PR\/HER2\/HER3 expression and will be evaluated for efficacy analysis. Part Z will enroll additional 21 subjects with HER2+ MBC.', 'Inclusion Criteria': \"Inclusion Criteria: Patients must meet the following criteria in order to be included in the research study: Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses Women and men at least 18 years-of-age at the time of signature of the informed consent form (ICF) Histologically documented locally advanced or metastatic breast cancer Triple-negative breast cancer patients should have received at least 1 but no more than 3 prior lines of chemotherapy in the metastatic setting Parts A and B (HER2-negative, ER-positive) patients only: HR+ breast cancer patients should have received prior treatment with endocrine therapy +CDK 4\/6 inhibitor. No limit to prior endocrine therapy regimens but no more than 2 prior chemotherapy regimens in the metastatic setting Part Z patients only should have documented HER2-positive expression as per American Society of Clinical Oncology - College of American Pathologists guidelines based on local testing. Part Z patients only should have had prior treatment with at least 2 anti-HER2 therapies, 1 of which must be T-DXd. These patients must have experienced disease progression after receiving T-DXd. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (bone-only disease excluded) Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed \u22654 weeks prior to initiation of study treatment (2 weeks for patients who received palliative radiation therapy), there is no evidence of central nervous system disease progression on a scan or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy for the treatment of brain metastases Willingness to undergo pre-treatment biopsy and on-treatment biopsies. Must have a tumor amenable to pre-treatment biopsy (unless archived tissue is available and was obtained within 2 months prior to starting treatment) and on-treatment biopsy (excludes bone lesions and previously irradiated lesions). Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Has adequate organ function within 7 days before the start of study treatment, defined as: Platelet count \u2265100 \u00d7 10^9\/L Hemoglobin (Hb) \u22659 g\/dL (transfusion and\/or growth factor support allowed) Absolute neutrophil count \u22651.5 \u00d7 10^9\/L Prothrombin time (PT) and partial thromboplastin time (PTT) \u22641.5 \u00d7 the upper limit of normal (ULN), except for patients on coumadin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-international normalized ratio (INR) within therapeutic range as deemed appropriate by the Investigator. Serum creatinine \u22641.5 \u00d7 ULN, or creatinine clearance \u2265 50 mL\/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 \u00d7 ULN. AST\/ALT \u22643 \u00d7 ULN (if liver metastases are present, \u22645 \u00d7 ULN) Total bilirubin \u22641.5 \u00d7 ULN if no liver metastases or < 3 \u00d7 ULN in the presence of documented Gilbert's syndrome or liver metastases Serum albumin \u2265 2.5 g\/dL Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for at least 7 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.\", 'Exclusion Criteria': \"Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry: Exclusion criteria for Part A and B (HER2-negative) and Part Z (HER2-positive) cohorts: Treatment with any of the following: Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of U3-1402. Prior treatment with any HER3 targeting agent Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment Chloroquine \/hydroxychloroquine \u226414 days prior to the first dose of study drug treatment. Has any hypersensitivity to drug substances or inactive ingredients in drug product. Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation. Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sj\u00f6gren's syndrome, sarcoidosis) OR prior pneumonectomy With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor. Leptomeningeal metastases or spinal cord compression due to disease Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment Any of the following cardiac criteria currently or within the last 6 months: Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block Congestive heart failure (New York Heart Association \u2265 Grade 2 [Appendix D]) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age Patients with a left ventricular ejection fraction (LVEF) <50% Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\/or follow-up procedures outlined in the protocol. Additional exclusion criteria only for Part A and B (HER2-negative) cohorts: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., T-DXd, DS-1062a, and DS-7300a) Patients with HER2+ breast cancer per ASCO-CAP guidelines Additional exclusion criteria only for Part Z (HER2-positive) cohort: Treatment with any of the following: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor except T-DXd Prior treatment with T-DXd within 4 weeks prior to the first dose of U3-1402 Uncontrolled or significant cardiovascular disease, including history of myocardial infarction within 6 months before enrollment A severe reaction or severe tolerability issues that necessitated stopping treatment with T-DXd Any unresolved toxicities from prior therapy with T-DXd.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Negative, HR-Positive, Regardless of HER3 expression Exclude: HER2-positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer', 'Brief Summary': 'This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 in patients with locally advanced or metastatic breast cancer (MBC).', 'Condition': 'Metastatic Breast Cancer Locally Advanced Breast Cancer', 'Detailed Description': 'U3-1302 is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This study is a phase II study of U3-1402 in subjects with MBC who have received no prior anti HER2 therapy. The study will be conducted in 3 parts (Part A, Part B, and Part Z). All enrolled subjects in part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER\/PR\/HER2\/HER3) show preliminary efficacy after an analysis is performed at 24 weeks. Part B will enroll subgroups of subjects that will be defined from part A based on ER\/PR\/HER2\/HER3 expression and will be evaluated for efficacy analysis. Part Z will enroll additional 21 subjects with HER2+ MBC.', 'Inclusion Criteria': \"Inclusion Criteria: Patients must meet the following criteria in order to be included in the research study: Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses Women and men at least 18 years-of-age at the time of signature of the informed consent form (ICF) Histologically documented locally advanced or metastatic breast cancer Triple-negative breast cancer patients should have received at least 1 but no more than 3 prior lines of chemotherapy in the metastatic setting Parts A and B (HER2-negative, ER-positive) patients only: HR+ breast cancer patients should have received prior treatment with endocrine therapy +CDK 4\/6 inhibitor. No limit to prior endocrine therapy regimens but no more than 2 prior chemotherapy regimens in the metastatic setting Part Z patients only should have documented HER2-positive expression as per American Society of Clinical Oncology - College of American Pathologists guidelines based on local testing. Part Z patients only should have had prior treatment with at least 2 anti-HER2 therapies, 1 of which must be T-DXd. These patients must have experienced disease progression after receiving T-DXd. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (bone-only disease excluded) Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed \u22654 weeks prior to initiation of study treatment (2 weeks for patients who received palliative radiation therapy), there is no evidence of central nervous system disease progression on a scan or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy for the treatment of brain metastases Willingness to undergo pre-treatment biopsy and on-treatment biopsies. Must have a tumor amenable to pre-treatment biopsy (unless archived tissue is available and was obtained within 2 months prior to starting treatment) and on-treatment biopsy (excludes bone lesions and previously irradiated lesions). Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Has adequate organ function within 7 days before the start of study treatment, defined as: Platelet count \u2265100 \u00d7 10^9\/L Hemoglobin (Hb) \u22659 g\/dL (transfusion and\/or growth factor support allowed) Absolute neutrophil count \u22651.5 \u00d7 10^9\/L Prothrombin time (PT) and partial thromboplastin time (PTT) \u22641.5 \u00d7 the upper limit of normal (ULN), except for patients on coumadin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-international normalized ratio (INR) within therapeutic range as deemed appropriate by the Investigator. Serum creatinine \u22641.5 \u00d7 ULN, or creatinine clearance \u2265 50 mL\/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 \u00d7 ULN. AST\/ALT \u22643 \u00d7 ULN (if liver metastases are present, \u22645 \u00d7 ULN) Total bilirubin \u22641.5 \u00d7 ULN if no liver metastases or < 3 \u00d7 ULN in the presence of documented Gilbert's syndrome or liver metastases Serum albumin \u2265 2.5 g\/dL Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for at least 7 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.\", 'Exclusion Criteria': \"Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry: Exclusion criteria for Part A and B (HER2-negative) and Part Z (HER2-positive) cohorts: Treatment with any of the following: Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of U3-1402. Prior treatment with any HER3 targeting agent Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment Chloroquine \/hydroxychloroquine \u226414 days prior to the first dose of study drug treatment. Has any hypersensitivity to drug substances or inactive ingredients in drug product. Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation. Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sj\u00f6gren's syndrome, sarcoidosis) OR prior pneumonectomy With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor. Leptomeningeal metastases or spinal cord compression due to disease Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment Any of the following cardiac criteria currently or within the last 6 months: Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block Congestive heart failure (New York Heart Association \u2265 Grade 2 [Appendix D]) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age Patients with a left ventricular ejection fraction (LVEF) <50% Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\/or follow-up procedures outlined in the protocol. Additional exclusion criteria only for Part A and B (HER2-negative) cohorts: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., T-DXd, DS-1062a, and DS-7300a) Patients with HER2+ breast cancer per ASCO-CAP guidelines Additional exclusion criteria only for Part Z (HER2-positive) cohort: Treatment with any of the following: Prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor except T-DXd Prior treatment with T-DXd within 4 weeks prior to the first dose of U3-1402 Uncontrolled or significant cardiovascular disease, including history of myocardial infarction within 6 months before enrollment A severe reaction or severe tolerability issues that necessitated stopping treatment with T-DXd Any unresolved toxicities from prior therapy with T-DXd.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Positive Exclude:HER2-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C', 'Brief Summary': 'A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation', 'Condition': 'KRAS p, G12c Mutated \/Advanced Metastatic NSCLC', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Men or women greater than or equal to 18 years old. ECOG \u2264 1 Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment', 'Exclusion Criteria': 'Exclusion Criteria: Active brain metastases Myocardial infarction within 6 months of study day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication'}","output":"{'Arm - Disease - Biomarker': 'KRASG12C mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C', 'Brief Summary': 'A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation', 'Condition': 'KRAS p, G12c Mutated \/Advanced Metastatic NSCLC', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Men or women greater than or equal to 18 years old. ECOG \u2264 1 Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment', 'Exclusion Criteria': 'Exclusion Criteria: Active brain metastases Myocardial infarction within 6 months of study day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication'}","output":"{'Arm - Disease - Biomarker': 'KRASG12C mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)', 'Brief Summary': 'This is a Phase Ib\/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.', 'Condition': 'Advanced Liver Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Stage 1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization Locally advanced or metastatic and\/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients Child-Pugh class A within 7 days prior to randomization Disease that is not amenable to curative surgical and\/or locoregional therapies No prior systemic treatment for HCC Life expectancy >= 3 months Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\/or additional biomarker status via central testing Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV) Negative HIV test at screening For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm Stage 2 ECOG Performance Status of 0, 1, or 2 Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)', 'Exclusion Criteria': 'Exclusion Criteria: Stage 1 Prior treatment with CD137 agonists or immune checkpoint inhibitors Treatment with investigational therapy within 28 days prior to initiation of study Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure Untreated or incompletely treated esophageal and\/or gastric varices with bleeding or at high risk for bleeding Prior bleeding event due to esophageal and\/or gastric varices within 6 months prior to initiation of study AEs from prior anti-cancer therapy that have not resolved to Grade <= 1 or better, with the exception of alopecia of any grade Inadequately controlled hypertension History of hypertensive crisis or hypertensive encephalopathy Significant vascular disease History of hemoptysis within 1 month prior to initiation of study Evidence of bleeding diathesis or significant coagulopathy Current or recent use of asprin (>325 mg\/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose Core biopsy or other minor surgical procedure within 3 days prior to initiation of study History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\/or clinical signs\/symptoms of GI obstruction Evidence of abdominal free air not explained by paracentesis or recent surgery Serious, non-healing\/dehiscing wound, active ulcer, or untreated bone fracture Grade >=2 proteinuria Metastatic disease involving major airways\/blood vessels, or centrally located mediastinal tumor masses of large volume History of intra-abdominal inflammatory process Radiotherapy within 28 days or abdominal\/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure Chronic daily treatment with NSAID Eligible only for control arm Stage 1 and 2 Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC History of hepatic encephalopathy Moderate or severe ascites HBV and HCV coinfection Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Active TB Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study History of malignancy other than HCC within 5 years prior to screening Severe infection within 4 weeks prior to initiation of study Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study Prior allogeneic stem cell or solid organ transplantation Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known allergy or hypersensitivity to any of the study drugs or any of their excipients Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1\/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1', 'Brief Summary': 'This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.', 'Condition': 'Advanced Cancer Metastatic Cancer Malignant Neoplastic Disease', 'Detailed Description': 'This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts Adequate organ function', 'Exclusion Criteria': 'Exclusion Criteria: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).', 'Brief Summary': 'This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.', 'Condition': 'Advanced Ovarian Cancer', 'Detailed Description': \"Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (F\u00e9d\u00e9ration Internationale de Gyn\u00e9cologie et d'Obst\u00e9trique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and\/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab. The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.\", 'Inclusion Criteria': 'Key Inclusion Criteria: Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and \/ or fallopian-tube cancer Patients must be aged \u226518 years of age. For patients enrolled in Japan that are aged <20 year All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery Evidence of presence or absence of BRCA1\/2 mutation in tumour tissue Mandatory provision of tumour sample for centralised tBRCA testing ECOG performance status 0-1 Patients must have preserved organ and bone marrow function Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test', 'Exclusion Criteria': 'Key Exclusion Criteria: Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology Prior systemic anti-cancer therapy for ovarian cancer Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation Prior treatment with PARP inhibitor or immune mediated therapy Planned intraperitoneal cytotoxic chemotherapy Active or prior documented autoimmune or inflammatory disorders Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness Clinically significant cardiovascular disease Patients with known brain metastases History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease \u22655 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed \u22653 years prior to registration, and that the patient remains free of recurrent or metastatic disease) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2 Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination\/comparator agents Breast feeding women'}","output":"{'Arm - Disease - Biomarker': 'Include: BRCA1\/2 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).', 'Brief Summary': 'This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.', 'Condition': 'Advanced Ovarian Cancer', 'Detailed Description': \"Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (F\u00e9d\u00e9ration Internationale de Gyn\u00e9cologie et d'Obst\u00e9trique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and\/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab. The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.\", 'Inclusion Criteria': 'Key Inclusion Criteria: Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and \/ or fallopian-tube cancer Patients must be aged \u226518 years of age. For patients enrolled in Japan that are aged <20 year All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery Evidence of presence or absence of BRCA1\/2 mutation in tumour tissue Mandatory provision of tumour sample for centralised tBRCA testing ECOG performance status 0-1 Patients must have preserved organ and bone marrow function Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test', 'Exclusion Criteria': 'Key Exclusion Criteria: Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology Prior systemic anti-cancer therapy for ovarian cancer Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation Prior treatment with PARP inhibitor or immune mediated therapy Planned intraperitoneal cytotoxic chemotherapy Active or prior documented autoimmune or inflammatory disorders Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness Clinically significant cardiovascular disease Patients with known brain metastases History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease \u22655 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed \u22653 years prior to registration, and that the patient remains free of recurrent or metastatic disease) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2 Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination\/comparator agents Breast feeding women'}","output":"{'Arm - Disease - Biomarker': 'Include: BRCA1\/2 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).', 'Brief Summary': 'This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.', 'Condition': 'Advanced Ovarian Cancer', 'Detailed Description': \"Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (F\u00e9d\u00e9ration Internationale de Gyn\u00e9cologie et d'Obst\u00e9trique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and\/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab. The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.\", 'Inclusion Criteria': 'Key Inclusion Criteria: Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and \/ or fallopian-tube cancer Patients must be aged \u226518 years of age. For patients enrolled in Japan that are aged <20 year All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery Evidence of presence or absence of BRCA1\/2 mutation in tumour tissue Mandatory provision of tumour sample for centralised tBRCA testing ECOG performance status 0-1 Patients must have preserved organ and bone marrow function Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test', 'Exclusion Criteria': 'Key Exclusion Criteria: Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology Prior systemic anti-cancer therapy for ovarian cancer Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation Prior treatment with PARP inhibitor or immune mediated therapy Planned intraperitoneal cytotoxic chemotherapy Active or prior documented autoimmune or inflammatory disorders Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness Clinically significant cardiovascular disease Patients with known brain metastases History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease \u22655 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed \u22653 years prior to registration, and that the patient remains free of recurrent or metastatic disease) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2 Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination\/comparator agents Breast feeding women'}","output":"{'Arm - Disease - Biomarker': 'Include: BRCA1\/2 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).', 'Brief Summary': 'This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.', 'Condition': 'Advanced Ovarian Cancer', 'Detailed Description': \"Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (F\u00e9d\u00e9ration Internationale de Gyn\u00e9cologie et d'Obst\u00e9trique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and\/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab. The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.\", 'Inclusion Criteria': 'Key Inclusion Criteria: Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and \/ or fallopian-tube cancer Patients must be aged \u226518 years of age. For patients enrolled in Japan that are aged <20 year All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery Evidence of presence or absence of BRCA1\/2 mutation in tumour tissue Mandatory provision of tumour sample for centralised tBRCA testing ECOG performance status 0-1 Patients must have preserved organ and bone marrow function Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test', 'Exclusion Criteria': 'Key Exclusion Criteria: Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology Prior systemic anti-cancer therapy for ovarian cancer Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation Prior treatment with PARP inhibitor or immune mediated therapy Planned intraperitoneal cytotoxic chemotherapy Active or prior documented autoimmune or inflammatory disorders Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness Clinically significant cardiovascular disease Patients with known brain metastases History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease \u22655 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed \u22653 years prior to registration, and that the patient remains free of recurrent or metastatic disease) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2 Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination\/comparator agents Breast feeding women'}","output":"{'Arm - Disease - Biomarker': 'Include: BRCA1\/2 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) or Placebo Combined With First-line Standard Chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer (NSCLC)', 'Brief Summary': 'This is one randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with standard 1st-line chemotherapy in treatment-na\u00efve advanced non-small cell lung cancer (NSCLC); and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population. About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion will be 2:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors: PD-L1 expression (TC\u22651% vs TC<1%); Smoking state (often smoking vs no smoking or infrequent smoking); Pathological type (squamous cell carcinoma vs non-squamous cell carcinoma).', 'Condition': 'Treatment-naive Advanced Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: Histologically and\/or cytologically confirmed stage IV non-small cell lung cancer and ALK fusion At least one measurable lesion 3 No history of any systemic anti-tumor therapy. 4. Agreement on providing formalin fixed tumor tissue specimen or fresh biopsy tissue from tumor lesions after diagnosis of metastasis 6. Age of 18-75 years 7. ECOG Scores 0-1; 8. Expected survival \u2265 3 months;', 'Exclusion Criteria': 'Exclusion Criteria: Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components; Histologically or cytopathologically confirmed combination with small cell lung cancer component or sarcomatoid lesion; Current participation in and receiving other study treatment, or participation in treatment of one study drug within 4 weeks prior to administration of JS001; Previous use of systematic chemotherapy for advanced NSCLC; targeted therapy for advanced NSCLC Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cells synergetic stimulation or checkpoint pathway, such as IDO, IL-2R, GITR); Chest (lung) radiotherapy > 30 Gy within 6 months prior to the start of study treatment. Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening; Known active central nervous system (CNS) metastasis and\/or cancerous meningitis; Spinal cord compression for which operation and\/or radical radiotherapy has not been given, or no clinical evidence of stable disease for \u22654 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage Uncontrollable or symptomatic hypercalcemia Clinically uncontrolled active infection, including but not limited to acute pneumonia; Uncontrollable major epileptic seizure or superior vena cava syndrome Previous or current combination with other malignancies ; History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening; Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease; Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle; Vaccination of live-virus vaccine within 30 days after the start of planned treatment'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) or Placebo Combined With First-line Standard Chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer (NSCLC)', 'Brief Summary': 'This is one randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with standard 1st-line chemotherapy in treatment-na\u00efve advanced non-small cell lung cancer (NSCLC); and evaluate the population with the best predictive biomarkers, i.e., positive diagnosis population. About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion will be 2:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy will be given in the study group whereas placebo combined with standard 1st-line chemotherapy will be given in the control group. The stratification will be based on the following factors: PD-L1 expression (TC\u22651% vs TC<1%); Smoking state (often smoking vs no smoking or infrequent smoking); Pathological type (squamous cell carcinoma vs non-squamous cell carcinoma).', 'Condition': 'Treatment-naive Advanced Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: Histologically and\/or cytologically confirmed stage IV non-small cell lung cancer and ALK fusion At least one measurable lesion 3 No history of any systemic anti-tumor therapy. 4. Agreement on providing formalin fixed tumor tissue specimen or fresh biopsy tissue from tumor lesions after diagnosis of metastasis 6. Age of 18-75 years 7. ECOG Scores 0-1; 8. Expected survival \u2265 3 months;', 'Exclusion Criteria': 'Exclusion Criteria: Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components; Histologically or cytopathologically confirmed combination with small cell lung cancer component or sarcomatoid lesion; Current participation in and receiving other study treatment, or participation in treatment of one study drug within 4 weeks prior to administration of JS001; Previous use of systematic chemotherapy for advanced NSCLC; targeted therapy for advanced NSCLC Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cells synergetic stimulation or checkpoint pathway, such as IDO, IL-2R, GITR); Chest (lung) radiotherapy > 30 Gy within 6 months prior to the start of study treatment. Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening; Known active central nervous system (CNS) metastasis and\/or cancerous meningitis; Spinal cord compression for which operation and\/or radical radiotherapy has not been given, or no clinical evidence of stable disease for \u22654 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage Uncontrollable or symptomatic hypercalcemia Clinically uncontrolled active infection, including but not limited to acute pneumonia; Uncontrollable major epileptic seizure or superior vena cava syndrome Previous or current combination with other malignancies ; History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening; Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease; Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle; Vaccination of live-virus vaccine within 30 days after the start of planned treatment'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers', 'Brief Summary': 'This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).', 'Condition': 'HER2-amplified Biliary Tract Cancers', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC. Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy. For subjects who received gemcitabine in prior adjuvant or neoadjuvant treatment, if progression occurred < 6 months from the latter of primary surgical resection or completion of gemcitabine-containing adjuvant therapy, they will be considered as having received 1 prior line of therapy for advanced disease. Subjects must test positive for HER2 amplification by ISH-assay at a central laboratory on a new biopsy or archival tissue. Note that fine needle aspirates (FNAs; cytology samples) and biopsies from sites of bone metastases are not acceptable. Testing may occur at any time after diagnosis of advanced or metastatic disease and before study enrollment. Male or female, \u226518 years of age (or the legal age of adulthood per country-specific regulations). Eastern Cooperative Oncology Group (ECOG) performance status \u2264 1. Adequate organ function. Adequate cardiac function, as defined by left ventricular ejection fraction \u2265 50%.', 'Exclusion Criteria': 'Exclusion Criteria: Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25. Received radiotherapy within 2 weeks of the first dose of ZW25. Prior treatment with HER2-targeted agents. Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening). Known leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the investigator, the subject must be free of neurological symptoms of LMD. Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, infected biloma or abscess. Any complications must be resolved more than 2 weeks prior to the first dose of ZW25. Prior or concurrent malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen. Active hepatitis Infection with human immunodeficiency virus (HIV)-1 or HIV-2 QTc Fridericia (QTcF) > 470 ms. History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.'}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 Amplification '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase I\/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I Only)', 'Brief Summary': 'This phase I\/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that have spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving navitoclax, dabrafenib, and trametinib may help shrink tumors in patients with melanoma.', 'Condition': 'Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Malignant Solid Neoplasm Metastatic Melanoma Unresectable Melanoma', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), toxicity, and safety profile of navitoclax when given in combination with dabrafenib and trametinib in patients with BRAF-mutant solid tumors. (Phase I) II. To estimate the complete response (CR) rate in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, and navitoclax as compared to the historical control dabrafenib and trametinib combination (DT). (Phase II) III. To compare the maximal tumor regression in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax. (Phase II) SECONDARY OBJECTIVES: I. To describe pharmacodynamics effects of treatment with dabrafenib, trametinib, and navitoclax on both serial tumor biopsies and serial blood draws in a small subset of patients treated with BRAF-mutant melanoma. (Phase I) II. To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and navitoclax. (Phase I) III. To compare the progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, versus dabrafenib, trametinib, and navitoclax. (Phase II) IV. To compare the degree of apoptosis induced in on-treatment biopsies of patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax. (Phase II) V. To explore other pharmacodynamic effects in on-treatment biopsies of patients with BRAF-mutant melanoma treated with either dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax including cell proliferation (Ki-67), proteomics (reverse-phase protein microarrays [RPPA]), and B-cell chronic lymphocytic leukemia (CLL)\/lymphoma 2 (BCL-2) family gene expression analysis. (Phase II) OUTLINE: This is a phase I, dose-escalation study of dabrafenib, trametinib, and navitoclax followed by a randomized phase II study. PHASE I: Patients receive navitoclax orally (PO) once daily (QD) on days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO twice daily (BID), trametinib PO QD, and navitoclax PO QD days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT), also undergo biopsy, and collection of blood samples throughout the trial. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial. ARM II: Patients receive navitoclax PO QD days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO BID, trametinib PO QD, and navitoclax PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial. After the completion of study treatment, patients are followed up for clinical evaluation at 28 days and every 3 months thereafter until disease progression or death, whichever comes first. For survival follow up, patients are followed every 12 months for 3 years.', 'Inclusion Criteria': 'Inclusion Criteria: PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and\/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients must have histologically confirmed, BRAF-mutant (V600E\/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a Clinical Laboratory Improvement Act [CLIA]-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective If test at CLIA-certified lab used a non-Food and Drug Administration (FDA) approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Prior therapy is allowed; for patients enrolled in the Phase II portion of the study, patients may have received prior immunotherapy (including high-dose IL-2, ipilimumab, nivolumab, and other anti-PD1\/PDL1 antibodies) or chemotherapy; however prior navitoclax, BRAF inhibitor and\/or MEK inhibitor therapy will not be allowed Age >= 18 years. Because no dosing or adverse event data are currently available on the use of navitoclax in combination with dabrafenib and trametinib in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Life expectancy of greater than 3 months Leukocytes >= 3,000\/mcL Absolute neutrophil count >= 1 x 10^9\/L Hemoglobin >= 9 g\/dl (patients may be transfused to this level) Platelets >= 100,000\/mcL Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])\/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal Prothrombin time (PT)\/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Serum creatinine =< 1.5 mg\/dL OR creatinine clearance >= 50 mL\/min\/1.73 m^2 Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) Patients must have a corrected QT (QTc) interval of less than 480 msec The effects of navitoclax, dabrafenib, and trametinib on the developing human fetus are unknown; for this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed due to drug-drug interactions which can render hormonal contraceptives ineffective) prior to study entry, for the duration of study participation, and for 4 months after completion of study drug administration; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; based on studies in animals, it is also known that dabrafenib may cause damage to the tissue that makes sperm; this may cause sperm to be abnormal in shape and size and could lead to infertility, which may be irreversible; safety and efficacy of the combination of dabrafenib and trametinib in pediatric populations have not been investigated; dabrafenib or trametinib-dabrafenib combination should not be administered to pediatric populations outside clinical trials Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels Ability to understand and the willingness to sign a written informed consent document; if a patient has impaired decision-making capacity, a legally authorized representative, patients will be allowed to participate', 'Exclusion Criteria': \"Exclusion Criteria: PHASE I SUBJECTS ONLY: Patients must not have received prior navitoclax, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients who have had immunotherapy, chemotherapy or radiotherapy within 14 days prior to the first dose of navitoclax, or prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to first dose of dabrafenib and\/or trametinib; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment; biologics will not be allowed within 30 days prior to, or during, navitoclax administration Prior navitoclax, BRAF inhibitor, and MEK inhibitor is prohibited; (exceptions for Phase I are described above) Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study Patients with treated leptomeningeal or brain metastasis are not eligible unless there is demonstrated stability (documented by imaging) for >= 3 months from any prior treatment of leptomeningeal or brain metastasis. Treatment may include surgery, radiation or systemic therapy. Patients with untreated leptomeningeal or brain metastasis or requiring corticosteroids are not eligible. Subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor. Subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks History of allergic reactions attributed to compounds of similar chemical or biologic composition to navitoclax, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO) Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness\/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because navitoclax, dabrafenib, and trametinib may have teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with the study drugs Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy that predict to interact with any of the study drugs are ineligible because of the potential for pharmacokinetic interactions with the study drugs; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; it is not necessary to conduct HIV testing at screening; patients who are HIV-positive with undetectable viral loads, not on interacting antiretroviral therapy, and have CD4 counts above 300\/mm^3 may be eligible after discussion with the principal investigator History of another malignancy; exception: patients who have been disease-free for 3 years (depending upon tumor type studied or clinical setting, 3 or 5 years can be used; e.g., for advanced melanoma and pancreatic studies 3 years is more appropriate due to aggressiveness of the disease, while 5 years can be more appropriate for prostate or ovarian cancer or adjuvant setting when life expectancy is longer), or patients with a history of completely resected non-melanoma skin cancer and\/or patients with indolent secondary malignancies, are eligible; consult the CTEP medical monitor if unsure whether second malignancies meet the requirements specified above; exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility History of interstitial lung disease or pneumonitis History or current evidence\/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes) Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mmHg History or evidence of cardiovascular risk including any of the following: A QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec on screening electrocardiography (ECG) History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible) History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and\/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation\/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study Known history of hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); it is not necessary to conduct HBV and HCV testing at screening Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding Subject has a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v. 5.0) grade 2 or higher from previous anti-cancer therapy, except alopecia or an endocrine toxicity related to immunotherapy (e.g. thyroiditis\/hypothyroidism, adrenal insufficiency, hypophysitis) requiring replacement therapy, at the time of randomization Due to the expected dose-limiting toxicity of thrombocytopenia, the following concomitant medications are not allowed during navitoclax administration: clopidogrel, ibuprofen, tirofiban, warfarin, and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000\/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor Current use of a prohibited medication; the following medications or non-drug therapies are prohibited: Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed) Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng) Anticoagulants or antiplatelet agents except for low-dose, aspirin Preclinical studies indicate that navitoclax is metabolized by CYP3A4, is a moderate inhibitor of CYP2C8, and is a strong inhibitor of CYP2C9; there is also evidence of interactions with dabrafenib; therefore, caution should be exercised when dosing navitoclax concurrently with CYP2C8 and CYP2C9 substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin; when possible, investigators should switch to alternative medications or monitor the patients closely; CYP3A inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of permeability-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded; below are a few examples of the agents: Strong inducers of CYP3A or CYP2C8, since concentrations of dabrafenib may be decreased: Antibiotics: rifamycin class agents (e.g., rifampin, rifabutin, rifapentine) Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, s-mephenytoin Miscellaneous: bosentan, St. John's wort Strong inhibitors of CYP3A or CYP2C8 since concentrations of dabrafenib may be increased: Antibiotics: clarithromycin, telithromycin, troleandomycin Antidepressants: nefazodone Antifungals: itraconazole, ketoconazole, posaconazole, voriconazole Hyperlipidemia: gemfibrozil Antiretroviral: ritonavir, saquinavir, atazanavir Miscellaneous: conivaptan\"}","output":"{'Arm - Disease - Biomarker': 'Include: BRAF-mutant (V600E\/K)'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase I\/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I Only)', 'Brief Summary': 'This phase I\/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that have spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving navitoclax, dabrafenib, and trametinib may help shrink tumors in patients with melanoma.', 'Condition': 'Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Malignant Solid Neoplasm Metastatic Melanoma Unresectable Melanoma', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), toxicity, and safety profile of navitoclax when given in combination with dabrafenib and trametinib in patients with BRAF-mutant solid tumors. (Phase I) II. To estimate the complete response (CR) rate in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, and navitoclax as compared to the historical control dabrafenib and trametinib combination (DT). (Phase II) III. To compare the maximal tumor regression in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax. (Phase II) SECONDARY OBJECTIVES: I. To describe pharmacodynamics effects of treatment with dabrafenib, trametinib, and navitoclax on both serial tumor biopsies and serial blood draws in a small subset of patients treated with BRAF-mutant melanoma. (Phase I) II. To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and navitoclax. (Phase I) III. To compare the progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, versus dabrafenib, trametinib, and navitoclax. (Phase II) IV. To compare the degree of apoptosis induced in on-treatment biopsies of patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax. (Phase II) V. To explore other pharmacodynamic effects in on-treatment biopsies of patients with BRAF-mutant melanoma treated with either dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax including cell proliferation (Ki-67), proteomics (reverse-phase protein microarrays [RPPA]), and B-cell chronic lymphocytic leukemia (CLL)\/lymphoma 2 (BCL-2) family gene expression analysis. (Phase II) OUTLINE: This is a phase I, dose-escalation study of dabrafenib, trametinib, and navitoclax followed by a randomized phase II study. PHASE I: Patients receive navitoclax orally (PO) once daily (QD) on days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO twice daily (BID), trametinib PO QD, and navitoclax PO QD days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT), also undergo biopsy, and collection of blood samples throughout the trial. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial. ARM II: Patients receive navitoclax PO QD days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO BID, trametinib PO QD, and navitoclax PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial. After the completion of study treatment, patients are followed up for clinical evaluation at 28 days and every 3 months thereafter until disease progression or death, whichever comes first. For survival follow up, patients are followed every 12 months for 3 years.', 'Inclusion Criteria': 'Inclusion Criteria: PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and\/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients must have histologically confirmed, BRAF-mutant (V600E\/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a Clinical Laboratory Improvement Act [CLIA]-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective If test at CLIA-certified lab used a non-Food and Drug Administration (FDA) approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Prior therapy is allowed; for patients enrolled in the Phase II portion of the study, patients may have received prior immunotherapy (including high-dose IL-2, ipilimumab, nivolumab, and other anti-PD1\/PDL1 antibodies) or chemotherapy; however prior navitoclax, BRAF inhibitor and\/or MEK inhibitor therapy will not be allowed Age >= 18 years. Because no dosing or adverse event data are currently available on the use of navitoclax in combination with dabrafenib and trametinib in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Life expectancy of greater than 3 months Leukocytes >= 3,000\/mcL Absolute neutrophil count >= 1 x 10^9\/L Hemoglobin >= 9 g\/dl (patients may be transfused to this level) Platelets >= 100,000\/mcL Total bilirubin =< 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])\/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal Prothrombin time (PT)\/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Serum creatinine =< 1.5 mg\/dL OR creatinine clearance >= 50 mL\/min\/1.73 m^2 Left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) Patients must have a corrected QT (QTc) interval of less than 480 msec The effects of navitoclax, dabrafenib, and trametinib on the developing human fetus are unknown; for this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed due to drug-drug interactions which can render hormonal contraceptives ineffective) prior to study entry, for the duration of study participation, and for 4 months after completion of study drug administration; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; based on studies in animals, it is also known that dabrafenib may cause damage to the tissue that makes sperm; this may cause sperm to be abnormal in shape and size and could lead to infertility, which may be irreversible; safety and efficacy of the combination of dabrafenib and trametinib in pediatric populations have not been investigated; dabrafenib or trametinib-dabrafenib combination should not be administered to pediatric populations outside clinical trials Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels Ability to understand and the willingness to sign a written informed consent document; if a patient has impaired decision-making capacity, a legally authorized representative, patients will be allowed to participate', 'Exclusion Criteria': \"Exclusion Criteria: PHASE I SUBJECTS ONLY: Patients must not have received prior navitoclax, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients who have had immunotherapy, chemotherapy or radiotherapy within 14 days prior to the first dose of navitoclax, or prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to first dose of dabrafenib and\/or trametinib; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment; biologics will not be allowed within 30 days prior to, or during, navitoclax administration Prior navitoclax, BRAF inhibitor, and MEK inhibitor is prohibited; (exceptions for Phase I are described above) Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study Patients with treated leptomeningeal or brain metastasis are not eligible unless there is demonstrated stability (documented by imaging) for >= 3 months from any prior treatment of leptomeningeal or brain metastasis. Treatment may include surgery, radiation or systemic therapy. Patients with untreated leptomeningeal or brain metastasis or requiring corticosteroids are not eligible. Subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor. Subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks History of allergic reactions attributed to compounds of similar chemical or biologic composition to navitoclax, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO) Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness\/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because navitoclax, dabrafenib, and trametinib may have teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with the study drugs Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy that predict to interact with any of the study drugs are ineligible because of the potential for pharmacokinetic interactions with the study drugs; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; it is not necessary to conduct HIV testing at screening; patients who are HIV-positive with undetectable viral loads, not on interacting antiretroviral therapy, and have CD4 counts above 300\/mm^3 may be eligible after discussion with the principal investigator History of another malignancy; exception: patients who have been disease-free for 3 years (depending upon tumor type studied or clinical setting, 3 or 5 years can be used; e.g., for advanced melanoma and pancreatic studies 3 years is more appropriate due to aggressiveness of the disease, while 5 years can be more appropriate for prostate or ovarian cancer or adjuvant setting when life expectancy is longer), or patients with a history of completely resected non-melanoma skin cancer and\/or patients with indolent secondary malignancies, are eligible; consult the CTEP medical monitor if unsure whether second malignancies meet the requirements specified above; exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility History of interstitial lung disease or pneumonitis History or current evidence\/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes) Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mmHg History or evidence of cardiovascular risk including any of the following: A QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec on screening electrocardiography (ECG) History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible) History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and\/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation\/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study Known history of hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); it is not necessary to conduct HBV and HCV testing at screening Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding Subject has a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v. 5.0) grade 2 or higher from previous anti-cancer therapy, except alopecia or an endocrine toxicity related to immunotherapy (e.g. thyroiditis\/hypothyroidism, adrenal insufficiency, hypophysitis) requiring replacement therapy, at the time of randomization Due to the expected dose-limiting toxicity of thrombocytopenia, the following concomitant medications are not allowed during navitoclax administration: clopidogrel, ibuprofen, tirofiban, warfarin, and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000\/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor Current use of a prohibited medication; the following medications or non-drug therapies are prohibited: Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed) Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng) Anticoagulants or antiplatelet agents except for low-dose, aspirin Preclinical studies indicate that navitoclax is metabolized by CYP3A4, is a moderate inhibitor of CYP2C8, and is a strong inhibitor of CYP2C9; there is also evidence of interactions with dabrafenib; therefore, caution should be exercised when dosing navitoclax concurrently with CYP2C8 and CYP2C9 substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin; when possible, investigators should switch to alternative medications or monitor the patients closely; CYP3A inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of permeability-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded; below are a few examples of the agents: Strong inducers of CYP3A or CYP2C8, since concentrations of dabrafenib may be decreased: Antibiotics: rifamycin class agents (e.g., rifampin, rifabutin, rifapentine) Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, s-mephenytoin Miscellaneous: bosentan, St. John's wort Strong inhibitors of CYP3A or CYP2C8 since concentrations of dabrafenib may be increased: Antibiotics: clarithromycin, telithromycin, troleandomycin Antidepressants: nefazodone Antifungals: itraconazole, ketoconazole, posaconazole, voriconazole Hyperlipidemia: gemfibrozil Antiretroviral: ritonavir, saquinavir, atazanavir Miscellaneous: conivaptan\"}","output":"{'Arm - Disease - Biomarker': 'Include: BRAF-mutant (V600E\/K)'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Efficacy and Safety of Neoadjuvant Therapy of Pembrolizumab Combined With Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer: An Open-label Single-arm Phase II Study', 'Brief Summary': 'The efficacy and safety of the neoadjuvant therapy of pembrolizumab+ ramucirumab', 'Condition': 'Non-small Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage II Non-small Cell Lung Cancer Stage \u2162A', 'Detailed Description': 'To demonstrate the antitumor activity and safety of neoadjuvant pembrolizumab plus ramucirumab followed by surgery in patients with PD-L1 positive stage IB-IIIA non-small cell lung cancer', 'Inclusion Criteria': \"Inclusion Criteria: Male\/female participants who are at least 20 years of age on the day of signing informed consent Previously untreated and histologically proven NSCLC harboring PD-L1 expression (\u22651% in a biopsy specimen), as measured by immunohistochemistry (22C3). Resectable clinical stage IB-IIIA NSCLC carefully evaluated by experienced thoracic surgeons. (If N2 disease is suspected, the histological or cytological confirmation is mandatory) (UICC version 8) Pulmonary resection more than lobectomy and lymph node dissection is considered to be possible for complete resection of the tumor.Be able to undergo protocol therapy, including necessary surgery. Has adequate pulmonary function for pulmonary resection. Predicted postoperative FEV1.0 is 800 mL or more. \uff5b(predicted postoperative FEV1.0) = (preoperative FEV1.0) x (18-number of resected segment) \/ 18\uff5d ECOG performance status of 0 to 1. Has measurable disease as defined by RECIST 1.1 as determined by investigator. Has adequate organ function as defined in the following criteria. Clinical test data must meet the following criteria within 14 days of the registration. The registration day is the standard, including the same day of the week two weeks prior. a Neutrophil count: \u2265 1500\/mm3 b Hemoglobin (Hb) \u2265 9.0 g\/dL c Platelet count: \u2265 10.0 \u00d7 104\/mm3 d AST (SGOT) \u2264 100 IU\/L e ALT (SGPT): \u2264 100 IU\/L f Total bilirubin: \u2264 1.5 mg\/dL (Total bilirubin: \u2264 3.0 mg\/dL for patient with Gilbert's syndrome) g Creatinine: CRE \u2264 1.5 mg\/dL, or creatinine clearance of 40 mL\/minute or higher [Even when the value is less than 40 mL\/min in the Cockcroft-Gault equation, if the measured value from a 24-hour urine collection is 40 mL\/min or higher, the patient qualifies.] * Cockcroft-Gault equation: Male: Ccr=\uff5b(140-age) \u00d7 body weight (kg)\uff5d\/\uff5b72 \u00d7 serum CRE value (mg\/dL\uff09\uff5dFemale: Ccr=0.85 \u00d7 \uff5b(140-age) \u00d7 body weight (kg)\uff5d\/\uff5b72 \u00d7 serum CRE value (mg\/dL) h SpO(2) \u2265 92% (room air) i International normalized ratio (INR) \u2264 1.5 j PTT(aPTT) \u2264 1.5 \u00d7 ULN k Urinary protein \u22641+ (if it is \u22652+, store the urine for 24 hours, and if the urinary protein is <1,000 mg, the patient is qualified). Female who are likely to become pregnant are negative with pregnancy tests (urine or serum) within 7 days prior to enrollment. They agree to conduct proper contraception (total abstinence, intrauterine contraceptive device, hormone release system, or contraceptive implant and oral contraceptive) for both men and women during the trial and from the final investigational dosing up to 120 days The participant is willing and able to provide written informed consent\/assent for the trial.\", 'Exclusion Criteria': \"Exclusion Criteria: Has one of the following tumor locations\/types: NSCLC involving the superior sulcus Large cell neuro-endocrine cancer (LCNEC) Sarcomatoid tumor Synchronous lung cancer (within 5 years), current non-pure GGN on TSCT, or pure GGN with 15mm or more on TSCT Has an active infection requiring systemic therapy. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Hypersensitivity or allergy to pembrolizumab, ramucirumab, or any of their excipients. Has a known history of, or any evidence of active, interstitial lung disease. Has a hypertension that is difficult to control (systolic blood pressure \u2265160 mmHg and diastolic blood pressure \u226590 mmHg) despite treatment with several hypotensive agents. Has an acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment Has a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months Has a severe (hospitalization required) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, liver cirrhosis, mental disease, cerebrovascular disease etc). Has a known history of human immunodeficiency virus (HIV) infection. No HIV resting is required unless mandated by local health authority. Has a known history of active TB (Bacillus Tuberculosis) Positivefor HBs antigens, HBs antibodies, and HBc antibodies. However, if positive for HBs and\/or HBc antibodies, the patient can be registered as long as they are negative for HBV-DNA. Positive for HCV antibody. However, if positive for HCV antibody, the patient can be registered as long as they are negative for HCV-RNA. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Has a known additional malignancy that is progressing or requires active treatment within the past (5 years) or received anti-cancer drug including hormone therapy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer, breast carcinoma, CIS and AIS of the lung) that have undergone potentially curative therapy are not excluded. Has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening or screening visit through 120 days after the last dose of trial treatment. Has history of hemoptysis (more than 1\/2 cups in teaspoon) in 2 months before registration, or invasion of major vessels by cancer or major vessel narrowing is recognized on the image. Image shows cavity formation in the tumor. Is considered highly likely to have complications related to bleeding. * Obvious tumor invasion to the chest great vessel, cavity formation of the lung lesion, or the existence of obvious thrombus on the image are recognized, etc. Has past history of gastrointestinal perforation, peptic ulcer, diverticulosis or fistula within 6 months. \u203b As for peptic ulcer, registration is permitted when disease condition is controlled by appropriate treatment. Has a history of pulmonary embolism \/ deep vein thrombosis, or other thromboembolism within 3 months before registration. Received major surgery within 28 days before registration, or received procedures for placement of subcutaneous venous access devices within seven days before registration. Severe wounds, ulcers or fractures within 28 days before registration. Has undergone long-term treatment using aspirin, nonsteroidal anti-inflammatory drugs (such as ibuprofen, naproxen), dipyridamole, clopidogrel or similar drugs. However, use of aspirin up to 325 mg \/ day once a day is acceptable. Patients who are receiving anticoagulant therapy and whose dose of oral anticoagulant or low molecular weight heparin is not stable. In case of taking warfarin, registration is permitted if there is no active bleeding or no risk of bleeding. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of registration. Note: Participants who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Has no intention to comply with the study protocol or it is impossible to comply. Investigator or clinical trial doctor judged unsuitable as subject of this trial.\"}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation', 'Brief Summary': 'This is a phase Ib\/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose \/ recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK\/PD of each regimen at the maximum tolerated dose \/ recommended dose or lower dose.', 'Condition': 'KRAS G12C Mutant Solid Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies ECOG Performance Status of 0 or 1 At least one measurable lesion as defined by RECIST 1.1 Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion', 'Exclusion Criteria': 'Exclusion Criteria: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible Clinically significant cardiac disease or risk factors at screening A medical condition that results in increased photosensitivity Other protocol-defined inclusion\/exclusion criteria may apply.'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutant Exclude: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation', 'Brief Summary': 'This is a phase Ib\/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose \/ recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK\/PD of each regimen at the maximum tolerated dose \/ recommended dose or lower dose.', 'Condition': 'KRAS G12C Mutant Solid Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies ECOG Performance Status of 0 or 1 At least one measurable lesion as defined by RECIST 1.1 Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion', 'Exclusion Criteria': 'Exclusion Criteria: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible Clinically significant cardiac disease or risk factors at screening A medical condition that results in increased photosensitivity Other protocol-defined inclusion\/exclusion criteria may apply.'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutant Exclude: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation', 'Brief Summary': 'This is a phase Ib\/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose \/ recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK\/PD of each regimen at the maximum tolerated dose \/ recommended dose or lower dose.', 'Condition': 'KRAS G12C Mutant Solid Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies ECOG Performance Status of 0 or 1 At least one measurable lesion as defined by RECIST 1.1 Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion', 'Exclusion Criteria': 'Exclusion Criteria: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible Clinically significant cardiac disease or risk factors at screening A medical condition that results in increased photosensitivity Other protocol-defined inclusion\/exclusion criteria may apply.'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutant Exclude: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib\/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation', 'Brief Summary': 'This is a phase Ib\/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose \/ recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK\/PD of each regimen at the maximum tolerated dose \/ recommended dose or lower dose.', 'Condition': 'KRAS G12C Mutant Solid Tumors Carcinoma, Non-Small-Cell Lung Carcinoma, Colorectal Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies ECOG Performance Status of 0 or 1 At least one measurable lesion as defined by RECIST 1.1 Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion', 'Exclusion Criteria': 'Exclusion Criteria: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible Clinically significant cardiac disease or risk factors at screening A medical condition that results in increased photosensitivity Other protocol-defined inclusion\/exclusion criteria may apply.'}","output":"{'Arm - Disease - Biomarker': 'Include: KRAS G12C mutant Exclude: Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors', 'Brief Summary': 'FIREFLY-1 is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known BRAF alteration.', 'Condition': 'Low-grade Glioma Advanced Solid Tumor', 'Detailed Description': 'The study will consist of the following treatment arms: Arm 1 (Low-Grade Glioma): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known activating BRAF alteration, including BRAF V600 mutations and KIAA1549:BRAF fusions. Arm 2 (Low-Grade Glioma Expanded Access): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known or expected to be activating RAF alteration (e.g., BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations). Opening of Arm 2 to enrollment will be based on the recommendation of the Data Safety Monitoring Board (DSMB). Arm 3 (Advanced Solid Tumor): Patients aged 6 months to 25 years, inclusive, with advanced solid tumors harboring a known or expected to be activating RAF fusion (e.g., BRAF or CRAF\/RAF1 fusion). Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the aforementioned arms. Patients will be treated with DAY101, an oral pan-RAF inhibitor, for a planned period of 26 cycles will be treated with DAY101 for a planned period of 26 cycles (approximately 24 months). DAY101 will be administered at the recommended Phase 2 dose (RP2D) of 420 mg\/m2 (not to exceed 600 mg) orally once weekly (QW) for each 28-day treatment cycle. Treatment cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients will undergo radiographic evaluation of their disease at the end of every third cycle. Patients will continue on DAY101 until radiographic evidence of disease progression by RANO (Arms 1 & 2) or RECIST v1.1 criteria (Arm 3) as determined by treating investigator, unacceptable toxicity, patient withdrawal of consent, or death. Patients who have radiographic evidence of disease progression may be allowed to continue DAY101 if, in the opinion of the investigator and approval by the Sponsor, the patient is deriving clinical benefit from continuing study treatment. Disease assessments for patients being treated beyond progression should continue as per regular schedule. DAY101 is an oral pan-RAF inhibitor administered as an oral tablet at 420 mg\/m2 (not to exceed 600 mg).', 'Inclusion Criteria': 'Inclusion Criteria: Age 6 months to 25 years with: Arms 1 & 2: a relapsed or progressive LGG with documented known activating BRAF alteration Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration Must have received at least one line of systemic therapy and have evidence of radiographic progression Must have at least 1 measurable lesion as defined by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria', 'Exclusion Criteria': \"Exclusion Criteria: Patient's tumor has additional previously-known activating molecular alterations Patient has symptoms of clinical progression in the absence of radiographic progression Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) Other inclusion\/exclusion criteria as stipulated by protocol may apply\"}","output":"{'Arm - Disease - Biomarker': 'BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations and KIAA1549:BRAF fusions'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors', 'Brief Summary': 'FIREFLY-1 is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known BRAF alteration.', 'Condition': 'Low-grade Glioma Advanced Solid Tumor', 'Detailed Description': 'The study will consist of the following treatment arms: Arm 1 (Low-Grade Glioma): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known activating BRAF alteration, including BRAF V600 mutations and KIAA1549:BRAF fusions. Arm 2 (Low-Grade Glioma Expanded Access): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known or expected to be activating RAF alteration (e.g., BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations). Opening of Arm 2 to enrollment will be based on the recommendation of the Data Safety Monitoring Board (DSMB). Arm 3 (Advanced Solid Tumor): Patients aged 6 months to 25 years, inclusive, with advanced solid tumors harboring a known or expected to be activating RAF fusion (e.g., BRAF or CRAF\/RAF1 fusion). Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the aforementioned arms. Patients will be treated with DAY101, an oral pan-RAF inhibitor, for a planned period of 26 cycles will be treated with DAY101 for a planned period of 26 cycles (approximately 24 months). DAY101 will be administered at the recommended Phase 2 dose (RP2D) of 420 mg\/m2 (not to exceed 600 mg) orally once weekly (QW) for each 28-day treatment cycle. Treatment cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients will undergo radiographic evaluation of their disease at the end of every third cycle. Patients will continue on DAY101 until radiographic evidence of disease progression by RANO (Arms 1 & 2) or RECIST v1.1 criteria (Arm 3) as determined by treating investigator, unacceptable toxicity, patient withdrawal of consent, or death. Patients who have radiographic evidence of disease progression may be allowed to continue DAY101 if, in the opinion of the investigator and approval by the Sponsor, the patient is deriving clinical benefit from continuing study treatment. Disease assessments for patients being treated beyond progression should continue as per regular schedule. DAY101 is an oral pan-RAF inhibitor administered as an oral tablet at 420 mg\/m2 (not to exceed 600 mg).', 'Inclusion Criteria': 'Inclusion Criteria: Age 6 months to 25 years with: Arms 1 & 2: a relapsed or progressive LGG with documented known activating BRAF alteration Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration Must have received at least one line of systemic therapy and have evidence of radiographic progression Must have at least 1 measurable lesion as defined by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria', 'Exclusion Criteria': \"Exclusion Criteria: Patient's tumor has additional previously-known activating molecular alterations Patient has symptoms of clinical progression in the absence of radiographic progression Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) Other inclusion\/exclusion criteria as stipulated by protocol may apply\"}","output":"{'Arm - Disease - Biomarker': 'BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations and KIAA1549:BRAF fusions'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors', 'Brief Summary': 'FIREFLY-1 is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known BRAF alteration.', 'Condition': 'Low-grade Glioma Advanced Solid Tumor', 'Detailed Description': 'The study will consist of the following treatment arms: Arm 1 (Low-Grade Glioma): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known activating BRAF alteration, including BRAF V600 mutations and KIAA1549:BRAF fusions. Arm 2 (Low-Grade Glioma Expanded Access): Patients aged 6 months to 25 years, inclusive, with recurrent or progressive low-grade glioma harboring a known or expected to be activating RAF alteration (e.g., BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations). Opening of Arm 2 to enrollment will be based on the recommendation of the Data Safety Monitoring Board (DSMB). Arm 3 (Advanced Solid Tumor): Patients aged 6 months to 25 years, inclusive, with advanced solid tumors harboring a known or expected to be activating RAF fusion (e.g., BRAF or CRAF\/RAF1 fusion). Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the aforementioned arms. Patients will be treated with DAY101, an oral pan-RAF inhibitor, for a planned period of 26 cycles will be treated with DAY101 for a planned period of 26 cycles (approximately 24 months). DAY101 will be administered at the recommended Phase 2 dose (RP2D) of 420 mg\/m2 (not to exceed 600 mg) orally once weekly (QW) for each 28-day treatment cycle. Treatment cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients will undergo radiographic evaluation of their disease at the end of every third cycle. Patients will continue on DAY101 until radiographic evidence of disease progression by RANO (Arms 1 & 2) or RECIST v1.1 criteria (Arm 3) as determined by treating investigator, unacceptable toxicity, patient withdrawal of consent, or death. Patients who have radiographic evidence of disease progression may be allowed to continue DAY101 if, in the opinion of the investigator and approval by the Sponsor, the patient is deriving clinical benefit from continuing study treatment. Disease assessments for patients being treated beyond progression should continue as per regular schedule. DAY101 is an oral pan-RAF inhibitor administered as an oral tablet at 420 mg\/m2 (not to exceed 600 mg).', 'Inclusion Criteria': 'Inclusion Criteria: Age 6 months to 25 years with: Arms 1 & 2: a relapsed or progressive LGG with documented known activating BRAF alteration Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration Must have received at least one line of systemic therapy and have evidence of radiographic progression Must have at least 1 measurable lesion as defined by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria', 'Exclusion Criteria': \"Exclusion Criteria: Patient's tumor has additional previously-known activating molecular alterations Patient has symptoms of clinical progression in the absence of radiographic progression Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) Other inclusion\/exclusion criteria as stipulated by protocol may apply\"}","output":"{'Arm - Disease - Biomarker': 'BRAF or CRAF\/RAF1 fusion or BRAF V600 mutations and KIAA1549:BRAF fusions'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) \/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer', 'Brief Summary': 'This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ \/ HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+\/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.', 'Condition': 'Breast Cancer', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Signed informed consent prior to study specific procedures. Age \u226518 years (or per national guidelines). Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer Patients with multicentric and\/or multifocal and\/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and\/or PR+ and HER2-. Patients must have histologically confirmed ER+ and\/or PR+, HER2-, early invasive breast cancer. Patients must have undergone adequate (definitive) breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization. ECOG performance status 0-1. Patients must be able and willing to swallow and retain oral medication. Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization. Patients who received neo\/adjuvant therapy must be after last dose of chemotherapy and\/or biologic therapy and must have sufficient resolution of side effects. Patients who received breast\/axilla\/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects. Patients must have sufficient resolution of any surgical side effects (no active wound healing complications). -Patients must either be initiating or have already started adjuvant hormonal treatment. - Patients who already received neo\/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy. Absolute neutrophil count \u2265 1,500\/\u00b5L Platelets \u2265 100,000\/ mm3 Hemoglobin \u2265 10g\/dL Total serum bilirubin \u2264 ULN; or total bilirubin \u2264 3.0 \u00d7 ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome. Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) \u2264 1.5 \u00d7 institutional ULN. Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance \u2265 60 mL\/min\/1.73 m2 for patients with serum creatinine levels above institutional ULN.\", 'Exclusion Criteria': 'Exclusion Criteria: Concurrent therapy with other Investigational Products. Prior therapy with any CDK inhibitor. Patients with Stage I or IV breast cancer are not eligible. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib. Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization. Uncontrolled intercurrent illness that would limit compliance with study requirements. Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization. Patients with a history of any malignancy are ineligible Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy. Patients on antiretroviral therapy. Patients with clinically significant history of any chronic liver disease. Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).'}","output":"{'Arm - Disease - Biomarker': 'Include: ER+ and\/or PR+, HER2-'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) \/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer', 'Brief Summary': 'This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ \/ HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+\/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.', 'Condition': 'Breast Cancer', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Signed informed consent prior to study specific procedures. Age \u226518 years (or per national guidelines). Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer Patients with multicentric and\/or multifocal and\/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and\/or PR+ and HER2-. Patients must have histologically confirmed ER+ and\/or PR+, HER2-, early invasive breast cancer. Patients must have undergone adequate (definitive) breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization. ECOG performance status 0-1. Patients must be able and willing to swallow and retain oral medication. Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization. Patients who received neo\/adjuvant therapy must be after last dose of chemotherapy and\/or biologic therapy and must have sufficient resolution of side effects. Patients who received breast\/axilla\/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects. Patients must have sufficient resolution of any surgical side effects (no active wound healing complications). -Patients must either be initiating or have already started adjuvant hormonal treatment. - Patients who already received neo\/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy. Absolute neutrophil count \u2265 1,500\/\u00b5L Platelets \u2265 100,000\/ mm3 Hemoglobin \u2265 10g\/dL Total serum bilirubin \u2264 ULN; or total bilirubin \u2264 3.0 \u00d7 ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome. Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) \u2264 1.5 \u00d7 institutional ULN. Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance \u2265 60 mL\/min\/1.73 m2 for patients with serum creatinine levels above institutional ULN.\", 'Exclusion Criteria': 'Exclusion Criteria: Concurrent therapy with other Investigational Products. Prior therapy with any CDK inhibitor. Patients with Stage I or IV breast cancer are not eligible. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib. Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization. Uncontrolled intercurrent illness that would limit compliance with study requirements. Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization. Patients with a history of any malignancy are ineligible Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy. Patients on antiretroviral therapy. Patients with clinically significant history of any chronic liver disease. Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).'}","output":"{'Arm - Disease - Biomarker': 'Include: ER+ and\/or PR+, HER2-'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations', 'Brief Summary': 'The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).', 'Condition': 'Urothelial Cancer', 'Detailed Description': 'A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or surgically unresectable urothelial cancer Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum) Participants must meet appropriate molecular eligibility criteria Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Adequate bone marrow, liver, and renal function', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. Symptomatic central nervous system metastases Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. History of uncontrolled cardiovascular disease Impaired wound healing capacity defined as skin\/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions'}","output":"{'Arm - Disease - Biomarker': 'Include: fibroblast growth factor receptor (FGFR) aberrations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations', 'Brief Summary': 'The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).', 'Condition': 'Urothelial Cancer', 'Detailed Description': 'A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or surgically unresectable urothelial cancer Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum) Participants must meet appropriate molecular eligibility criteria Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Adequate bone marrow, liver, and renal function', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. Symptomatic central nervous system metastases Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. History of uncontrolled cardiovascular disease Impaired wound healing capacity defined as skin\/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions'}","output":"{'Arm - Disease - Biomarker': 'Include: fibroblast growth factor receptor (FGFR) aberrations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations', 'Brief Summary': 'The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).', 'Condition': 'Urothelial Cancer', 'Detailed Description': 'A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or surgically unresectable urothelial cancer Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum) Participants must meet appropriate molecular eligibility criteria Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Adequate bone marrow, liver, and renal function', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. Symptomatic central nervous system metastases Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. History of uncontrolled cardiovascular disease Impaired wound healing capacity defined as skin\/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions'}","output":"{'Arm - Disease - Biomarker': 'Include: fibroblast growth factor receptor (FGFR) aberrations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations', 'Brief Summary': 'The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).', 'Condition': 'Urothelial Cancer', 'Detailed Description': 'A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.', 'Inclusion Criteria': 'Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or surgically unresectable urothelial cancer Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum) Participants must meet appropriate molecular eligibility criteria Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Adequate bone marrow, liver, and renal function', 'Exclusion Criteria': 'Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence. Symptomatic central nervous system metastases Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade. History of uncontrolled cardiovascular disease Impaired wound healing capacity defined as skin\/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions'}","output":"{'Arm - Disease - Biomarker': 'Include: fibroblast growth factor receptor (FGFR) aberrations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below: Disease stage: II vs IIIA vs IIIB PD-L1 status: PD-L1 expression \u22651% vs. PD-L1 <1% or not evaluable Planned surgical operation: pneumonectomy vs. lobectomy Pathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W \/plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle. All the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy. After 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research. All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg\/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg\/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF); Aged 18-70 years, male or female; Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm\uff0c partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid\/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1; Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable); ECOG score 0-1; Good organ function: Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study; pulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug. Women of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug', 'Exclusion Criteria': \"Presence of locally advanced, unresectable or metastatic disease; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC; N2: single station mediastinal lymph node metastasis with short diameter \u22653cm; N2: multiple station mediastinal lymph node metastasis with lymph node fusion and the short diameter of lymph node \u22652cm on CT; ALL the N3; T4: invading esophagus, heart, aorta; NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor; Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma; Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product; History of (non-infectious) pneumonitis\/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis\/interstitial lung disease requiring steroid treatment; Active tuberculosis; Active infection requiring systemic treatment; Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU\/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA); Known human immunodeficiency virus (HIV) infection (known positive HIV antibody); Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella\/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Gu\u00e9rin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); \u2265 Grade 2 peripheral neuropathy; Previous use of PD-1\/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40); Severe allergic reaction to other monoclonal antibodies; History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications; Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months; History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators; Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded.\"}","output":"{'Arm - Disease - Biomarker': 'Include : PD-L1 Exclude : EGFR sensitive mutations, ALK translocation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below: Disease stage: II vs IIIA vs IIIB PD-L1 status: PD-L1 expression \u22651% vs. PD-L1 <1% or not evaluable Planned surgical operation: pneumonectomy vs. lobectomy Pathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W \/plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle. All the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy. After 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research. All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg\/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg\/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF); Aged 18-70 years, male or female; Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm\uff0c partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid\/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1; Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable); ECOG score 0-1; Good organ function: Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study; pulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug. Women of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug', 'Exclusion Criteria': \"Presence of locally advanced, unresectable or metastatic disease; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC; N2: single station mediastinal lymph node metastasis with short diameter \u22653cm; N2: multiple station mediastinal lymph node metastasis with lymph node fusion and the short diameter of lymph node \u22652cm on CT; ALL the N3; T4: invading esophagus, heart, aorta; NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor; Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma; Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product; History of (non-infectious) pneumonitis\/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis\/interstitial lung disease requiring steroid treatment; Active tuberculosis; Active infection requiring systemic treatment; Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU\/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA); Known human immunodeficiency virus (HIV) infection (known positive HIV antibody); Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella\/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Gu\u00e9rin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); \u2265 Grade 2 peripheral neuropathy; Previous use of PD-1\/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40); Severe allergic reaction to other monoclonal antibodies; History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications; Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months; History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators; Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded.\"}","output":"{'Arm - Disease - Biomarker': 'Include : PD-L1 Exclude : EGFR sensitive mutations, ALK translocation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+\/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria: Participants must meet all of the following criteria to be eligible for randomization\/registration into the study: Adults aged \u226520 years in Japan, Taiwan, and Korea, or those aged \u226518 years in other countries, at the time the Informed Consent Forms (ICFs) are signed. Pathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site. The following therapies should be included in prior lines of therapy: Fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated Anti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated Anti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated Anti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high\/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated Confirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+\/ in situ hybridization (ISH) +. Presence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Has left ventricular ejection fraction (LVEF) \u226550% within 28 days before randomization\/registration.', 'Exclusion Criteria': \"KEY Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: Medical history of myocardial infarction (MI) within 6 months before randomization\/registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal (ULN) at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before randomization\/registration to rule out MI. Has a corrected QT interval corrected with Fridericia's formula (QTcF) prolongation to >470 msec (female participants) or >450 msec (male participants) based on the average of the Screening triplicate 12-lead electrocardiograms (ECGs). Has a history of (non-infectious) interstitial lung disease (ILD)\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at Screening. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the randomization\/registration, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.). Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sj\u00f6gren syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of Screening. Prior pneumonectomy. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiotherapy and randomization\/registration. Participants with leptomeningeal carcinomatosis. Has known human immunodeficiency virus (HIV) infection. Active hepatitis B and\/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days before study randomization\/registration. Participants with past or resolved hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core antigen (anti-HBc) positive (+). Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Previous treatment with a DXd-containing antibody-drug conjugate (ADC).\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Overexpressing, BRAF Wild-type'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+\/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria: Participants must meet all of the following criteria to be eligible for randomization\/registration into the study: Adults aged \u226520 years in Japan, Taiwan, and Korea, or those aged \u226518 years in other countries, at the time the Informed Consent Forms (ICFs) are signed. Pathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site. The following therapies should be included in prior lines of therapy: Fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated Anti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated Anti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated Anti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high\/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated Confirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+\/ in situ hybridization (ISH) +. Presence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Has left ventricular ejection fraction (LVEF) \u226550% within 28 days before randomization\/registration.', 'Exclusion Criteria': \"KEY Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: Medical history of myocardial infarction (MI) within 6 months before randomization\/registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal (ULN) at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before randomization\/registration to rule out MI. Has a corrected QT interval corrected with Fridericia's formula (QTcF) prolongation to >470 msec (female participants) or >450 msec (male participants) based on the average of the Screening triplicate 12-lead electrocardiograms (ECGs). Has a history of (non-infectious) interstitial lung disease (ILD)\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at Screening. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the randomization\/registration, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.). Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sj\u00f6gren syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of Screening. Prior pneumonectomy. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiotherapy and randomization\/registration. Participants with leptomeningeal carcinomatosis. Has known human immunodeficiency virus (HIV) infection. Active hepatitis B and\/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days before study randomization\/registration. Participants with past or resolved hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core antigen (anti-HBc) positive (+). Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Previous treatment with a DXd-containing antibody-drug conjugate (ADC).\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Overexpressing, BRAF Wild-type'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': \"This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.\", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. To evaluate the frequency and severity of adverse events within each treatment arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms. ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible STEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab NOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and\/or PCI per the discretion of their treating investigator STEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC STEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC STEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration STEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as: At least two (3-5 microns) (three slides preferred) unstained slides, or; One (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide Participants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\\'t exceed the window of starting maintenance therapy STEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines STEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system STEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) STEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\\'s tumor sample is SLFN11 positive STEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest\/abdomen\/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET\/CT of chest\/abdomen\/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET\/CT of chest\/abdomen\/pelvis is used to assess measurable disease prior to Step 2 Registration STEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization STEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator STEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab STEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum\/etoposide\/atezolizumab STEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment) STEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous\/nonexfoliative rash Any unresolved grade 2 irAE Any toxicity that led to permanent discontinuation of prior anti-PD-1\/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed STEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification STEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization. STEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Platelets >= 100 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)\/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL\/min (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole STEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%) STEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease STEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study STEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted STEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB) STEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation STEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and\/or talazoparib STEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen STEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment STEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of \"reproductive potential\" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines STEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system STEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)', 'Exclusion Criteria': '-'}","output":"{'Arm - Disease - Biomarker': 'Include: SLFN11-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': \"This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.\", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. To evaluate the frequency and severity of adverse events within each treatment arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms. ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible STEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab NOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and\/or PCI per the discretion of their treating investigator STEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC STEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC STEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration STEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as: At least two (3-5 microns) (three slides preferred) unstained slides, or; One (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide Participants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\\'t exceed the window of starting maintenance therapy STEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines STEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system STEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) STEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\\'s tumor sample is SLFN11 positive STEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest\/abdomen\/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET\/CT of chest\/abdomen\/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET\/CT of chest\/abdomen\/pelvis is used to assess measurable disease prior to Step 2 Registration STEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization STEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator STEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab STEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum\/etoposide\/atezolizumab STEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment) STEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous\/nonexfoliative rash Any unresolved grade 2 irAE Any toxicity that led to permanent discontinuation of prior anti-PD-1\/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed STEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification STEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization. STEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Platelets >= 100 x 10^3\/mL (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)\/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL\/min (within 28 days prior to Step 2 Randomization) STEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole STEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%) STEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease STEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study STEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted STEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB) STEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation STEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and\/or talazoparib STEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen STEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment STEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of \"reproductive potential\" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines STEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system STEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)', 'Exclusion Criteria': '-'}","output":"{'Arm - Disease - Biomarker': 'Include: SLFN11-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Locally advanced, unresectable, or metastatic disease based on most recent imaging. The respective cohorts for patient inclusion are: Cohort 1: Biliary tract cancer Cohort 2: Bladder cancer Cohort 3: Cervical cancer Cohort 4: Endometrial cancer Cohort 5: Epithelial ovarian cancer Cohort 6: Pancreatic cancer Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer. Progressed following prior treatment or who have no satisfactory alternative treatment option. Prior HER2 targeting therapy is permitted. HER2 expression for eligibility may be based on local or central assessment. Has measurable target disease assessed by the Investigator based on RECIST version 1.1. Has protocol- defined adequate organ function including cardiac, renal and hepatic function.', 'Exclusion Criteria': \"Exclusion Criteria: History of non-infectious pneumonitis\/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant severe illnesses Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer. Medical conditions that may interfere with the subject's participation in the study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-Expressing, Exclude: known Somatic DNA mutation of HER2 without tumoral HER2 protein expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER\/PR-positive Ovarian Cancer.', 'Brief Summary': 'The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER\/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Letrozole (Femara\u00ae) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance\u00ae) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4\/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4\/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13. Based on the results of phase 1 and 2 clinical trials of CDK4\/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER\/PR expression, its combination with Letrozole can improve outcomes in ER\/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.', 'Inclusion Criteria': \"Inclusion Criteria: Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 18 years of age or older; Patient agrees not to participate in another interventional study while on treatment; Histology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic; Estrogen (ER) and\/or progesterone (RP) receptor positive tumor, defined as > 10% by immunohistochemical examination in the local laboratory; Availability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and\/or RP in a central laboratory; Disease measurable by RECIST 1.1 as assessed by the local investigator or radiologist; Patients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria: at least one platinum-based chemotherapy regimen; have confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease Patient must have radiographic disease progression to last treatment; Functional capacity by the Eastern Cooperative Oncology Group (ECOG) \u2264 2; Adequate bone marrow function: Absolute neutrophil count (CAN) \u2265 1,500\/mm3 (\u2265 1.5x109\/L) Plates \u2265 100,000\/mm3 or \u2265 100 x 109\/L Hemoglobin \u2265 9.0 g\/dL; 12. Adequate liver function: Total serum bilirubin \u2264 1.5 x upper limit of normal (ULN) (\u2264 3.0 x ULN if there is Gilbert's Syndrome) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u2264 3.0 x ULN (\u2264 5.0 x ULN if liver tumor was involved) Alkaline phosphatase \u2264 2.5 x ULN (\u2264 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function: Estimated creatinine clearance \u2265 15 mL\/min; 14. Evidence of lack of potential to become pregnant: Post-menopause (defined as at least 1 year without menstruation) before selection, or Radiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or Surgical sterilization (bilateral oophorectomy or hysterectomy).\", 'Exclusion Criteria': \"Exclusion Criteria: Patients with a known hypersensitivity to Palbociclib or Letrozole or any of the excipients of the product; Previous treatment with CDK4\/6 inhibitors or endocrine therapy; Disease progression during or within 6 months of the first platinum-based chemotherapy regimen. Persistent toxicities (Grade 2 or higher) caused by previous anticancer therapy (excluding alopecia); Patients with a second primary cancer, except: adequately treated non-melanoma skin cancer, cervical cancer in situ curatively treated, Ductal carcinoma in situ (DCIS), stage 1 grade 1 endometrial carcinoma curatively treated with no evidence of illness for 3 years; Last dose of chemotherapy or radiotherapy within 3 weeks of study enrollment; Patients with symptomatic uncontrolled brain metastases. An exam to confirm the absence of brain metastases is not necessary; Major surgical procedure within 3 weeks prior to study randomization, or planned during the course of the study; Patients considered a precarious medical risk due to a disorder uncontrolled serious medical, non-malignant systemic disease, or uncontrolled active infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; Patients who have difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that interferes with intestinal absorption of medications (eg, partial bowel obstruction or malabsorption); Patients received potent inhibitors or inducers of CYP3A4 within 7 days of randomization; Pregnant or nursing women; The patient has a known history of testing positive for human immunodeficiency virus (HIV); Patients with known liver disease (ie, Hepatitis B or C); Treatment with any product under investigation during the last 28 days; Other acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for entry into this study.\"}","output":"{'Arm - Disease - Biomarker': 'Include: PR-Positive, ER-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced\/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study. Approximately 120 subjects with CR\/PR\/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups: Arm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Male of female \u2265 18 years of age Have an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment Diagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction HER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -) Locally advanced\/metastatic gastric or gastroesophageal junction cancer CR\/PR\/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy Measurable disease according to RECIST 1.1 criteria Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment: Total bilirubin 1.5 times the upper limit of normal (ULN) Alanine aminotransferase and aspartate aminotransferase 3 times the ULN Lipase 1.5 times the ULN Serum creatinine 1.5 times the ULN Glomerular filtration rate 30 mL\/min\/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula International normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history. Platelet count 100,000 \/mm3, hemoglobin 9 g\/dL, absolute neutrophil count 1500\/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors Alkaline phosphatase \u2264 2.5 times the ULN Understand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.', 'Exclusion Criteria': \"Exclusion Criteria: Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) Have used biologic response modifiers, such as G-CSF, within 3 weeks of study entry Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor. Completed their last dose of chemotherapy more than 8 weeks, whichever came later, prior to randomization. Have had prior or concurrent cancer distinct in primary site or histology from GC or GJC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, no-melanoma skin cancer, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1). Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and\/or hormonal therapy within 4 weeks prior to initiation of study treatment. Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy\/procedure, excluding alopecia and\/or oxaliplatin-induced neurotoxicity \u2264 Grade 2 and hemoglobin \u2265 9 g\/dL as per inclusion criteria Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. Are pregnant. Are breastfeeding. Are unable to swallow oral tablets (crushing of study treatment tablets is not allowed). Have congestive heart failure classified as New York Heart Association Class 2 or higher Have had unstable angina (angina symptoms at rest) or new-onset angina 3 months prior to screening. Have had a myocardial infarction 6 months prior to initiation of study treatment. Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin. Have uncontrolled hypertension (systolic blood pressure [SBP] 140 mmHg or diastolic blood pressure [DBP] 90 mmHg) despite optimal medical management. Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment. Have an ongoing infection with severity of Grade 2 or above (NCI-CTCAE v 4.0). Have a known history of human immunodeficiency virus infection. Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy. Have a seizure disorder requiring medication. Have a history of organ allograft. Have evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity. Have had a hemorrhage or a bleeding event Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment. Have a nonhealing wound, ulcer, or bone fracture. Have renal failure requiring hemodialysis or peritoneal dialysis. Have dehydration Grade 1 (NCI-CTCAE v 4.0). Have interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained. Have persistent proteinuria > 3.5 g\/24 hours measured by urine protein creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 4.0). Have any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and\/or his\/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results. Have a known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs. Have any malabsorption condition. Have a close affiliation with the investigational site (eg, be a close relative of the investigator) or be a dependent person (eg, be an employee or student working at the investigational site). Untreated gastro-esophageus varices\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced\/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study. Approximately 120 subjects with CR\/PR\/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups: Arm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Male of female \u2265 18 years of age Have an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment Diagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction HER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -) Locally advanced\/metastatic gastric or gastroesophageal junction cancer CR\/PR\/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy Measurable disease according to RECIST 1.1 criteria Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment: Total bilirubin 1.5 times the upper limit of normal (ULN) Alanine aminotransferase and aspartate aminotransferase 3 times the ULN Lipase 1.5 times the ULN Serum creatinine 1.5 times the ULN Glomerular filtration rate 30 mL\/min\/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula International normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history. Platelet count 100,000 \/mm3, hemoglobin 9 g\/dL, absolute neutrophil count 1500\/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors Alkaline phosphatase \u2264 2.5 times the ULN Understand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.', 'Exclusion Criteria': \"Exclusion Criteria: Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) Have used biologic response modifiers, such as G-CSF, within 3 weeks of study entry Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor. Completed their last dose of chemotherapy more than 8 weeks, whichever came later, prior to randomization. Have had prior or concurrent cancer distinct in primary site or histology from GC or GJC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, no-melanoma skin cancer, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1). Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and\/or hormonal therapy within 4 weeks prior to initiation of study treatment. Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy\/procedure, excluding alopecia and\/or oxaliplatin-induced neurotoxicity \u2264 Grade 2 and hemoglobin \u2265 9 g\/dL as per inclusion criteria Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. Are pregnant. Are breastfeeding. Are unable to swallow oral tablets (crushing of study treatment tablets is not allowed). Have congestive heart failure classified as New York Heart Association Class 2 or higher Have had unstable angina (angina symptoms at rest) or new-onset angina 3 months prior to screening. Have had a myocardial infarction 6 months prior to initiation of study treatment. Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin. Have uncontrolled hypertension (systolic blood pressure [SBP] 140 mmHg or diastolic blood pressure [DBP] 90 mmHg) despite optimal medical management. Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment. Have an ongoing infection with severity of Grade 2 or above (NCI-CTCAE v 4.0). Have a known history of human immunodeficiency virus infection. Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy. Have a seizure disorder requiring medication. Have a history of organ allograft. Have evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity. Have had a hemorrhage or a bleeding event Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment. Have a nonhealing wound, ulcer, or bone fracture. Have renal failure requiring hemodialysis or peritoneal dialysis. Have dehydration Grade 1 (NCI-CTCAE v 4.0). Have interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained. Have persistent proteinuria > 3.5 g\/24 hours measured by urine protein creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 4.0). Have any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and\/or his\/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results. Have a known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs. Have any malabsorption condition. Have a close affiliation with the investigational site (eg, be a close relative of the investigator) or be a dependent person (eg, be an employee or student working at the investigational site). Untreated gastro-esophageus varices\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced\/advanced gastric or combined gastroesophageal adenocarcinoma with different gene\/protein types. Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria. RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0\/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT). Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form. Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set. Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented. Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred. Treatment protocol: All subjects in this study were first tested for genes\/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene\/protein expression. Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment. Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer Gastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Voluntarily sign the informed consent form for this study. Male or female patients aged 18-75 years. unresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination. >6 months from the end of prior (neo)adjuvant chemotherapy\/adjuvant radiotherapy to the time of disease recurrence at least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria) ECOG score: 0 to 1. Life expectancy \u2265 3 months. Adequate organ function, with the following laboratory test values required at screening. Routine blood test criteria to be met. Hemoglobin level (HB) \u2265 90 g\/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L. Platelet count (PLT) \u2265100\u00d7109\/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) \u22654.0\u00d7109\/L (no granulocyte stimulating factor within 14 days). Biochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) \u2264 1.5 times the upper limit of normal (ULN). ALT and AST \u2264 2.5 ULN. Cr \u2264 1.5 ULN or creatinine clearance (CCr) \u2265 60 ml\/min, (Cockcroft-Gault formula). Serum albumin \u2265 25 g\/L (2.5 g\/dL). For subjects with liver metastases, AST and ALT must be \u2264 5 x ULN, leukocytes \u2265 4 x 109\/L, untransfused platelets \u2265 100 x 109\/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment \u2265 1.5 x 109\/L, hemoglobin \u2265 90 g\/L Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \u2265 low limit of normal (50%). Adequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) \u2264 1.5 times ULN. Women of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration. If local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.', 'Exclusion Criteria': \"Exclusion Criteria: Hypersensitivity to any of the test drugs and their excipients, or a history of severe allergy, or a contraindication to the test drug. A history or active stage of autoimmune disease. symptomatic\/asymptomatic brain metastases CT suggestive of definite ulcerative lesions or positive fecal occult blood (risk of bleeding and suitability for enrollment as determined by the investigator) History of abnormal bleeding (except epistaxis) complained of 14 days prior to enrollment previous allogeneic bone marrow transplantation or organ transplantation congenital pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia, or CT-confirmed active pneumonia HIV positive test, active hepatitis B or C, active tuberculosis. Uncontrolled cancer pain. previous live attenuated vaccine within 4 weeks prior to study entry or expected to be administered during or within 5 months of the end of the trial Prior treatment with PD-1\/PD-L1 antibodies, CTLA-4 antibodies, or other therapies targeting PD-1\/PD-L1 and\/or VEGFR inhibitors or have not recovered from adverse events caused by dosing >4 weeks prior (i.e., have not returned to \u2264 grade 1 or baseline levels)). Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to trial start (note: inhaled glucocorticoids and salicorticoids are permitted). Known presence of symptomatic CNS metastases and\/or carcinomatous meningitis. Patients with a history of CNS metastases or spinal cord compression may be enrolled in the study if they are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study. Have a contraindication to hormone use. Have multiple factors that interfere with oral drug administration (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction) peripheral neuropathy \u2265 NCI CTCAE grade 2. Uncontrollable or symptomatic hypercalcemia. infections requiring antibiotics within 14 days prior to the start of the trial chronic enterocolitis. Patients with bone metastases at risk of paraplegia. Patients with any severe and\/ or uncontrolled disease, including: Patients with suboptimal blood pressure control (systolic blood pressure \u2265 150 mmHg or diastolic blood pressure \u2265 100 mmHg) on antihypertensive medications; patients with class II or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval \u2265 480 ms); class III-IV cardiac insufficiency by NYHA criteria, or cardiac ultrasound suggestive of left ventricular ejection fraction ( LVEF) <50% in patients. Active or uncontrolled severe infections. Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10 mmol\/L). Urine routine suggestive of urine protein \u2265++ and confirmed 24-hour urine protein quantification >1.0 g. Long-term untreated wounds or fractures 23) Subjects who are unable to receive a trans-peripheral central venous placement (PICC) Subjects with abnormal coagulation (INR > 1.5 or APTT > 1.5 \u00d7 ULN), with bleeding tendency or on thrombolytic or anticoagulant therapy. Known hereditary or acquired bleeding and thrombotic tendencies such as: hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc. Active bleeding within 14 prior to study entry. Major surgical procedure (craniotomy, open-heart or open-heart surgery) within 4 weeks prior to the first dose of study, or anticipated need for major surgery during study treatment, or non-diagnostic surgery within 4 weeks prior to the start of the trial. history of gastrointestinal perforation and\/or fistula within 3 months prior to enrollment in treatment; or arterial\/venous thrombotic events such as cerebrovascular accidents (except stable cerebral infarction as assessed by the investigator), deep vein thrombosis, and pulmonary embolism (except if cured) Clinically significant thoracoabdominal fluid, including any thoracoabdominal fluid that is detectable on physical examination, previously treated or currently still requiring treatment Those with only a small amount of thoracic ascites on imaging but asymptomatic, which the investigator assesses does not require treatment may be enrolled. Interstitial lung disease requiring steroid hormone therapy. uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer that can lead to higher medical risk and\/or uncertainty in survival evaluation Patients with significant malnutrition. Patients with a history of psychotropic substance abuse and inability to abstain or with psychiatric disorders those with a history of immunodeficiency, including testing positive for HIV or having other acquired, congenital immunodeficiency disorders, or a history of organ transplantation History of other primary malignancies, except for 1) malignancies in complete remission for at least 2 years prior to enrollment and requiring no other treatment during the study period; 2) non-melanoma skin cancers or malignant freckled nevi that have been adequately treated and have no evidence of disease recurrence; and 3) carcinomas in situ that have been adequately treated and have no evidence of disease recurrence. Female patients who are pregnant or breastfeeding. those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study Participating in another trial within 30 days prior to the start of the trial, or planning to participate in another trial while the trial is ongoing. Inclusion in the row with the most stringent conditions, if there is duplication.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 positive, Claudin 18.2 positive, HER2 negative, Claudin 18.2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced\/advanced gastric or combined gastroesophageal adenocarcinoma with different gene\/protein types. Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria. RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0\/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT). Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form. Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set. Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented. Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred. Treatment protocol: All subjects in this study were first tested for genes\/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene\/protein expression. Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment. Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer Gastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Voluntarily sign the informed consent form for this study. Male or female patients aged 18-75 years. unresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination. >6 months from the end of prior (neo)adjuvant chemotherapy\/adjuvant radiotherapy to the time of disease recurrence at least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria) ECOG score: 0 to 1. Life expectancy \u2265 3 months. Adequate organ function, with the following laboratory test values required at screening. Routine blood test criteria to be met. Hemoglobin level (HB) \u2265 90 g\/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L. Platelet count (PLT) \u2265100\u00d7109\/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) \u22654.0\u00d7109\/L (no granulocyte stimulating factor within 14 days). Biochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) \u2264 1.5 times the upper limit of normal (ULN). ALT and AST \u2264 2.5 ULN. Cr \u2264 1.5 ULN or creatinine clearance (CCr) \u2265 60 ml\/min, (Cockcroft-Gault formula). Serum albumin \u2265 25 g\/L (2.5 g\/dL). For subjects with liver metastases, AST and ALT must be \u2264 5 x ULN, leukocytes \u2265 4 x 109\/L, untransfused platelets \u2265 100 x 109\/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment \u2265 1.5 x 109\/L, hemoglobin \u2265 90 g\/L Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \u2265 low limit of normal (50%). Adequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) \u2264 1.5 times ULN. Women of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration. If local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.', 'Exclusion Criteria': \"Exclusion Criteria: Hypersensitivity to any of the test drugs and their excipients, or a history of severe allergy, or a contraindication to the test drug. A history or active stage of autoimmune disease. symptomatic\/asymptomatic brain metastases CT suggestive of definite ulcerative lesions or positive fecal occult blood (risk of bleeding and suitability for enrollment as determined by the investigator) History of abnormal bleeding (except epistaxis) complained of 14 days prior to enrollment previous allogeneic bone marrow transplantation or organ transplantation congenital pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia, or CT-confirmed active pneumonia HIV positive test, active hepatitis B or C, active tuberculosis. Uncontrolled cancer pain. previous live attenuated vaccine within 4 weeks prior to study entry or expected to be administered during or within 5 months of the end of the trial Prior treatment with PD-1\/PD-L1 antibodies, CTLA-4 antibodies, or other therapies targeting PD-1\/PD-L1 and\/or VEGFR inhibitors or have not recovered from adverse events caused by dosing >4 weeks prior (i.e., have not returned to \u2264 grade 1 or baseline levels)). Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to trial start (note: inhaled glucocorticoids and salicorticoids are permitted). Known presence of symptomatic CNS metastases and\/or carcinomatous meningitis. Patients with a history of CNS metastases or spinal cord compression may be enrolled in the study if they are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study. Have a contraindication to hormone use. Have multiple factors that interfere with oral drug administration (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction) peripheral neuropathy \u2265 NCI CTCAE grade 2. Uncontrollable or symptomatic hypercalcemia. infections requiring antibiotics within 14 days prior to the start of the trial chronic enterocolitis. Patients with bone metastases at risk of paraplegia. Patients with any severe and\/ or uncontrolled disease, including: Patients with suboptimal blood pressure control (systolic blood pressure \u2265 150 mmHg or diastolic blood pressure \u2265 100 mmHg) on antihypertensive medications; patients with class II or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval \u2265 480 ms); class III-IV cardiac insufficiency by NYHA criteria, or cardiac ultrasound suggestive of left ventricular ejection fraction ( LVEF) <50% in patients. Active or uncontrolled severe infections. Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10 mmol\/L). Urine routine suggestive of urine protein \u2265++ and confirmed 24-hour urine protein quantification >1.0 g. Long-term untreated wounds or fractures 23) Subjects who are unable to receive a trans-peripheral central venous placement (PICC) Subjects with abnormal coagulation (INR > 1.5 or APTT > 1.5 \u00d7 ULN), with bleeding tendency or on thrombolytic or anticoagulant therapy. Known hereditary or acquired bleeding and thrombotic tendencies such as: hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc. Active bleeding within 14 prior to study entry. Major surgical procedure (craniotomy, open-heart or open-heart surgery) within 4 weeks prior to the first dose of study, or anticipated need for major surgery during study treatment, or non-diagnostic surgery within 4 weeks prior to the start of the trial. history of gastrointestinal perforation and\/or fistula within 3 months prior to enrollment in treatment; or arterial\/venous thrombotic events such as cerebrovascular accidents (except stable cerebral infarction as assessed by the investigator), deep vein thrombosis, and pulmonary embolism (except if cured) Clinically significant thoracoabdominal fluid, including any thoracoabdominal fluid that is detectable on physical examination, previously treated or currently still requiring treatment Those with only a small amount of thoracic ascites on imaging but asymptomatic, which the investigator assesses does not require treatment may be enrolled. Interstitial lung disease requiring steroid hormone therapy. uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer that can lead to higher medical risk and\/or uncertainty in survival evaluation Patients with significant malnutrition. Patients with a history of psychotropic substance abuse and inability to abstain or with psychiatric disorders those with a history of immunodeficiency, including testing positive for HIV or having other acquired, congenital immunodeficiency disorders, or a history of organ transplantation History of other primary malignancies, except for 1) malignancies in complete remission for at least 2 years prior to enrollment and requiring no other treatment during the study period; 2) non-melanoma skin cancers or malignant freckled nevi that have been adequately treated and have no evidence of disease recurrence; and 3) carcinomas in situ that have been adequately treated and have no evidence of disease recurrence. Female patients who are pregnant or breastfeeding. those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study Participating in another trial within 30 days prior to the start of the trial, or planning to participate in another trial while the trial is ongoing. Inclusion in the row with the most stringent conditions, if there is duplication.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 positive, Claudin 18.2 positive, HER2 negative, Claudin 18.2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib\/II Clinical Study of First-line Treatment of Unresectable Locally Advanced\/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced\/advanced gastric or combined gastroesophageal adenocarcinoma with different gene\/protein types. Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria. RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0\/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT). Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form. Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set. Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented. Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred. Treatment protocol: All subjects in this study were first tested for genes\/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene\/protein expression. Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment. Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer Gastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Voluntarily sign the informed consent form for this study. Male or female patients aged 18-75 years. unresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination. >6 months from the end of prior (neo)adjuvant chemotherapy\/adjuvant radiotherapy to the time of disease recurrence at least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria) ECOG score: 0 to 1. Life expectancy \u2265 3 months. Adequate organ function, with the following laboratory test values required at screening. Routine blood test criteria to be met. Hemoglobin level (HB) \u2265 90 g\/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L. Platelet count (PLT) \u2265100\u00d7109\/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) \u22654.0\u00d7109\/L (no granulocyte stimulating factor within 14 days). Biochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) \u2264 1.5 times the upper limit of normal (ULN). ALT and AST \u2264 2.5 ULN. Cr \u2264 1.5 ULN or creatinine clearance (CCr) \u2265 60 ml\/min, (Cockcroft-Gault formula). Serum albumin \u2265 25 g\/L (2.5 g\/dL). For subjects with liver metastases, AST and ALT must be \u2264 5 x ULN, leukocytes \u2265 4 x 109\/L, untransfused platelets \u2265 100 x 109\/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment \u2265 1.5 x 109\/L, hemoglobin \u2265 90 g\/L Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \u2265 low limit of normal (50%). Adequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) \u2264 1.5 times ULN. Women of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration. If local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.', 'Exclusion Criteria': \"Exclusion Criteria: Hypersensitivity to any of the test drugs and their excipients, or a history of severe allergy, or a contraindication to the test drug. A history or active stage of autoimmune disease. symptomatic\/asymptomatic brain metastases CT suggestive of definite ulcerative lesions or positive fecal occult blood (risk of bleeding and suitability for enrollment as determined by the investigator) History of abnormal bleeding (except epistaxis) complained of 14 days prior to enrollment previous allogeneic bone marrow transplantation or organ transplantation congenital pulmonary fibrosis, drug-induced pneumonia, mechanized pneumonia, or CT-confirmed active pneumonia HIV positive test, active hepatitis B or C, active tuberculosis. Uncontrolled cancer pain. previous live attenuated vaccine within 4 weeks prior to study entry or expected to be administered during or within 5 months of the end of the trial Prior treatment with PD-1\/PD-L1 antibodies, CTLA-4 antibodies, or other therapies targeting PD-1\/PD-L1 and\/or VEGFR inhibitors or have not recovered from adverse events caused by dosing >4 weeks prior (i.e., have not returned to \u2264 grade 1 or baseline levels)). Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to trial start (note: inhaled glucocorticoids and salicorticoids are permitted). Known presence of symptomatic CNS metastases and\/or carcinomatous meningitis. Patients with a history of CNS metastases or spinal cord compression may be enrolled in the study if they are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study. Have a contraindication to hormone use. Have multiple factors that interfere with oral drug administration (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction) peripheral neuropathy \u2265 NCI CTCAE grade 2. Uncontrollable or symptomatic hypercalcemia. infections requiring antibiotics within 14 days prior to the start of the trial chronic enterocolitis. Patients with bone metastases at risk of paraplegia. Patients with any severe and\/ or uncontrolled disease, including: Patients with suboptimal blood pressure control (systolic blood pressure \u2265 150 mmHg or diastolic blood pressure \u2265 100 mmHg) on antihypertensive medications; patients with class II or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval \u2265 480 ms); class III-IV cardiac insufficiency by NYHA criteria, or cardiac ultrasound suggestive of left ventricular ejection fraction ( LVEF) <50% in patients. Active or uncontrolled severe infections. Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis. Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10 mmol\/L). Urine routine suggestive of urine protein \u2265++ and confirmed 24-hour urine protein quantification >1.0 g. Long-term untreated wounds or fractures 23) Subjects who are unable to receive a trans-peripheral central venous placement (PICC) Subjects with abnormal coagulation (INR > 1.5 or APTT > 1.5 \u00d7 ULN), with bleeding tendency or on thrombolytic or anticoagulant therapy. Known hereditary or acquired bleeding and thrombotic tendencies such as: hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc. Active bleeding within 14 prior to study entry. Major surgical procedure (craniotomy, open-heart or open-heart surgery) within 4 weeks prior to the first dose of study, or anticipated need for major surgery during study treatment, or non-diagnostic surgery within 4 weeks prior to the start of the trial. history of gastrointestinal perforation and\/or fistula within 3 months prior to enrollment in treatment; or arterial\/venous thrombotic events such as cerebrovascular accidents (except stable cerebral infarction as assessed by the investigator), deep vein thrombosis, and pulmonary embolism (except if cured) Clinically significant thoracoabdominal fluid, including any thoracoabdominal fluid that is detectable on physical examination, previously treated or currently still requiring treatment Those with only a small amount of thoracic ascites on imaging but asymptomatic, which the investigator assesses does not require treatment may be enrolled. Interstitial lung disease requiring steroid hormone therapy. uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer that can lead to higher medical risk and\/or uncertainty in survival evaluation Patients with significant malnutrition. Patients with a history of psychotropic substance abuse and inability to abstain or with psychiatric disorders those with a history of immunodeficiency, including testing positive for HIV or having other acquired, congenital immunodeficiency disorders, or a history of organ transplantation History of other primary malignancies, except for 1) malignancies in complete remission for at least 2 years prior to enrollment and requiring no other treatment during the study period; 2) non-melanoma skin cancers or malignant freckled nevi that have been adequately treated and have no evidence of disease recurrence; and 3) carcinomas in situ that have been adequately treated and have no evidence of disease recurrence. Female patients who are pregnant or breastfeeding. those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study Participating in another trial within 30 days prior to the start of the trial, or planning to participate in another trial while the trial is ongoing. Inclusion in the row with the most stringent conditions, if there is duplication.\"}","output":"{'Arm - Disease - Biomarker': 'Include: HER2 positive, Claudin 18.2 positive, HER2 negative, Claudin 18.2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)', 'Brief Summary': 'The purpose of this study is to define the objective response rates (ORR) of Lorlatinib in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.', 'Condition': 'Anaplastic Large Cell Lymphoma, ALK-Positive', 'Detailed Description': 'Lorlatinib is a selective and potent tyrosine kinase inhibitor of ALK and ROS1 that pre-clinically demonstrated dose-dependent inhibition of mutations that confer resistance to other ALK inhibitors; it is also a brain-penetrant thus it might be active in patients with CNS metastases. Study Objectives Primary Define the objective response rates (ORR) of PF-06463922 in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors. Secondary Define the Progression Free Survival (PFS) in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors. Define the overall survival (OS) in ALK+ lymphoma patients treated with Lorlatinib, that are resistant or refractory to ALK inhibitors. Determine the toxicity profile of Lorlatinib in ALK+ lymphoma patients resistant or refractory to ALK inhibitors. Determine the Quality of Life (QoL) in this population of patients using the EORTC-C30 Quality of Life questionnaire. Study the mutational status of ALK pre\/post Lorlatinib treatment through next-generation sequencing (NGS). Study design This is a phase 2 study open to 12 eligible patients with lymphoma with a confirmed ALK rearrangement. All patients must have been pretreated with at least one line of standard cytotoxic chemotherapy and at least one ALK inhibitor and they must have demonstrated progression (regardless of initial response) or resistance on the last treatment. The study begins with a screening period to assess eligibility, up to and including 28 days prior to the first dose of Lorlatinib. Treatment will continue until patient experiences unacceptable toxicity or progressive disease (PD), starts a new anti-cancer therapy or dies. The study will remain open until all patients have completed 3 years from the enrollment. Study treatment Patients will receive an oral administration of Lorlatinib at a dose of 100mg QD. In case of toxicity, it is possible to proceed to a dose reduction (75mg or 50mg QD) or a temporary interruption of Lorlatinib.', 'Inclusion Criteria': \"Inclusion Criteria: Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures. ALK+ Lymphoma diagnosed by IHC or FISH. Refractory disease or relapse after at least one prior chemotherapy regimen (typically a minimum of 6 cycles of CHOP) and at least one ALK inhibitor; presence of measurable disease by physical examination, CT or CT-PET scan. Any prior antitumor medical treatment or major surgeries must have been completed at least 14 days prior to initiation of study medication. This could not be respected if there is clear evidence of disease progression, manifested as growing pain attributable to the tumour, fever, growing tumour lesions, increasing LDH values. Systemic anti-cancer therapy completed within a minimum of 5 half-lives of study entry. Able to take oral therapy. Female or male, 18 years of age or older. ECOG performance status 0-3. Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \u2264 2.5 x upper limit of normal (ULN) or AST and ALT \u2264 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin 1.5 x ULN (except patients with documented Gilbert's syndrome Creatinine \u2264 1.5 x ULN. Adequate bone marrow function: Absolute neutrophil count (ANC) \u2265 1000\/\u00b5L Platelets \u2265 50.000\/\u00b5L Hemoglobin \u2265 9.0 g\/dL The hematological values will not be considered in case of bone marrow involvement. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Female and male patients who are of childbearing potential must agree to use an effective form of contraception (2 forms of contraception) with their partners throughout participation in this study and for at least 90 days after the last dose of treatment.\", 'Exclusion Criteria': 'Exclusion Criteria: Current treatment on another therapeutic clinical trial. Clinically significant cardiovascular disease (that is, active or <3 months prior to enrollment): cerebral vascular accident\/stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class \u2265 II) Ongoing cardiac dysrhythmias of NCI CTCAE Grade \u22652: second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome. Pregnancy or breastfeeding. Use of drugs or foods that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates. Prior malignancy other than basal cell carcinoma , if original diagnosis happened in the last 5 years. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g. uncontrolled hyperglycemia, current gallstone disease, alcoholism). Hypertriglyceridemia \u2265 grade 1. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and\/or sponsor, excess risk associated with study participation or study drug administration.'}","output":"{'Arm - Disease - Biomarker': 'Include: ALK positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase \u0428 Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy\u00b1Bevacizumab Versus Placebo Plus Chemotherapy\u00b1Bevacizumab for PD-L1 Positive (CPS\u22651) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy\u00b1bevacizumab versus placebo plus chemotherapy\u00b1bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS\u22651), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001\uff0bChemotherapy\u00b1Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS\u22651)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS\u22651) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase \u2162 trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase \u2162 study. The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': \"Inclusion Criteria: Age \u2265 18 and \u2264 70 on the day of signing informed consent and volunteered to participated in this study. Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and\/or radiation). (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI. Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose. Has a predicted survival period \u2265 3 months assessed by investigators. Adverse reactions from the previous anti-tumor treatment have not yet recovered to \u2264 level 1 based on CTCAE 5.0. Adequate organ function as defined below: Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) \u22651.5\u00d710^9\/L; Platelets \u2265100 \u00d710^9\/L; Hemoglobin (HGB)\u22659 g\/dL; Serum biochemical indexs: Serum creatinine \u22641.5 \u00d7 ULN or >1.5 \u00d7 ULN with creatinine clearance (CCr) \u2265 60 mL\/min; Serum total bilirubin (TBIL) \u2264 1.5 \u00d7 ULN (Patients with Gilbert's syndrome can be up to 3 \u00d7 ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u22642.5 \u00d7 ULN or \u22645 X ULN for patients with liver metastases; Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)\u22641.5 \u00d7 ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).\", 'Exclusion Criteria': 'Exclusion Criteria: Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc). History of primary immunodeficiency. History of active tuberculosis. Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers. Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled). History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy. Patients with active soft meningeal disease or poorly controlled brain metastasis. Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc. Has received prior radiotherapy within 14 days prior to the first dose. Has received prior chemosensitizer within 14 days prior to the first dose. Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator. Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage. Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose. Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg\/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period. planned to receive during the study period. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose. History of organ transplant or allogenic haemopoietic stem cell transplantation. Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and\/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded. Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening. History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation. Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab. Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted). Women of child-bearing potential (WOCBP) refuse to take reliable contraceptive methods from signing the informed consent form to 6 months after last dose of investigational drug. Not suitable for this study as determined by the investigator due to other reasons.'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase \u0428 Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy\u00b1Bevacizumab Versus Placebo Plus Chemotherapy\u00b1Bevacizumab for PD-L1 Positive (CPS\u22651) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy\u00b1bevacizumab versus placebo plus chemotherapy\u00b1bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS\u22651), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001\uff0bChemotherapy\u00b1Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS\u22651)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS\u22651) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase \u2162 trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase \u2162 study. The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': \"Inclusion Criteria: Age \u2265 18 and \u2264 70 on the day of signing informed consent and volunteered to participated in this study. Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and\/or radiation). (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI. Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose. Has a predicted survival period \u2265 3 months assessed by investigators. Adverse reactions from the previous anti-tumor treatment have not yet recovered to \u2264 level 1 based on CTCAE 5.0. Adequate organ function as defined below: Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) \u22651.5\u00d710^9\/L; Platelets \u2265100 \u00d710^9\/L; Hemoglobin (HGB)\u22659 g\/dL; Serum biochemical indexs: Serum creatinine \u22641.5 \u00d7 ULN or >1.5 \u00d7 ULN with creatinine clearance (CCr) \u2265 60 mL\/min; Serum total bilirubin (TBIL) \u2264 1.5 \u00d7 ULN (Patients with Gilbert's syndrome can be up to 3 \u00d7 ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u22642.5 \u00d7 ULN or \u22645 X ULN for patients with liver metastases; Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)\u22641.5 \u00d7 ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).\", 'Exclusion Criteria': 'Exclusion Criteria: Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc). History of primary immunodeficiency. History of active tuberculosis. Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers. Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled). History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy. Patients with active soft meningeal disease or poorly controlled brain metastasis. Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc. Has received prior radiotherapy within 14 days prior to the first dose. Has received prior chemosensitizer within 14 days prior to the first dose. Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator. Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage. Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose. Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg\/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period. planned to receive during the study period. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose. History of organ transplant or allogenic haemopoietic stem cell transplantation. Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and\/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded. Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening. History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation. Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab. Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted). Women of child-bearing potential (WOCBP) refuse to take reliable contraceptive methods from signing the informed consent form to 6 months after last dose of investigational drug. Not suitable for this study as determined by the investigator due to other reasons.'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'An Open Label, Single-Arm, Multi-center Phase Ib\/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent\/Advanced Gastric Cancer With FGFs\/FGFRs Genetic Aberration.', 'Brief Summary': 'This study was conducted as a second-line treatment of recurrent \/ progressive gastric cancer patients with FGFs \/ FGFRs genetic mutations in the Ib \/ II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs \/ FGFRs genetic mutations.', 'Condition': 'Fibroblast Growth Factors (FGFs)\/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel', 'Detailed Description': 'phase> - Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle. phase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs \/ FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.', 'Inclusion Criteria': 'Inclusion Criteria: Patients who agreed in writing to the clinical study consent Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum. FGFs \/ FGFRs have genetic variation on NGS. Patients whose life expectancy is at least 3 months If the Eastern Cooperative Oncology Group (ECOG) is 0 or 1 Measurable or assessable lesion based on RECIST 1.1 scale Must be swallowed, should be able to take oral medication Possible long-term function to receive chemotherapy. Patients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment', 'Exclusion Criteria': 'Exclusion Criteria: When chemotherapy exceeded the first treatment Patients with multiple cancers Severe hypersensitivity reactions to anti-FGFR2 agents either now or in the past Patients with endocrine metabolic syndrome or history of calcium-phosphate homeostasis Patients with ectopic neoplasm or history of soft tissue, kidney, large intestine, heart, or abdomen Corneal lesions such as bullous keratopathy, corneal erosion, corneal erosion, corneal ulcer, corneal inflammation and keratoconjunctivitis were confirmed by ophthalmic examination Patients with metastasis to the brain or meninges. However, patients who do not have symptoms and do not need treatment can register. Clinically significant digestive system problems that can cause abnormalities in taking or absorbing clinical drugs Patients with uncontrollable or significant cardiovascular disease Patients with systemic infections requiring treatment Patients who were exposed to paclitaxel at or before the taxane If you undergo major surgery within 28 days before enrollment for this trial Patients who received radiotherapy for gastric cancer within 28 days prior to enrollment for this trial. However, the investigation of bone turnover was conducted within 14 days before the registration for this trial If you received general chemotherapy within 14 days of enrollment for this trial Patients who are positive for human immunodeficiency virus (HIV-1) antibody test, HBsAg results positive, HBV viral load greater than 2000 IU \/ ml (104 copies \/ ml), or HCV antibody test positive Patients who are pregnant, lactating, or are likely to be pregnant Anemia and hair loss are excluded if previous chemotherapy treatment has toxicity that is not recovered below grade 2. Patients who are judged to have lost their ability to cope with dementia or other comorbid conditions Other Patients who the examiner or the examiner deemed inappropriate for the clinical trial.'}","output":"{'Arm - Disease - Biomarker': 'Include: FGFs\/FGFRs Genetic Aberration'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria: Age \u226518 years at the time of screening and female. Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. Patient must have endometrial cancer in one of the following categories: Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. Na\u00efve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse FPPE tumor sample must be available for MMR evaluation. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.', 'Exclusion Criteria': 'Exclusion Criteria: History of leptomeningeal carcinomatosis. Brain metastases or spinal cord compression. Prior treatment with PARP inhibitors. Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.'}","output":"{'Arm - Disease - Biomarker': 'Include: MMR evaluation.'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria: Age \u226518 years at the time of screening and female. Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. Patient must have endometrial cancer in one of the following categories: Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. Na\u00efve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse FPPE tumor sample must be available for MMR evaluation. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.', 'Exclusion Criteria': 'Exclusion Criteria: History of leptomeningeal carcinomatosis. Brain metastases or spinal cord compression. Prior treatment with PARP inhibitors. Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.'}","output":"{'Arm - Disease - Biomarker': 'Include: MMR evaluation.'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria: Age \u226518 years at the time of screening and female. Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. Patient must have endometrial cancer in one of the following categories: Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. Na\u00efve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse FPPE tumor sample must be available for MMR evaluation. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.', 'Exclusion Criteria': 'Exclusion Criteria: History of leptomeningeal carcinomatosis. Brain metastases or spinal cord compression. Prior treatment with PARP inhibitors. Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.'}","output":"{'Arm - Disease - Biomarker': 'Include: MMR evaluation.'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2\/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed\/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided). Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy. Maintenance therapy will not be counted as a separate line of systemic therapy. Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\/CT should be between 3 to 5. Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician. Adequate bone marrow function at screening, defined as: Absolute neutrophil count (ANC) \u22651*10^9 per liter (\/L). Platelet count \u2265100*10^9\/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]). Hemoglobin \u22658.5 gram per deciliter (g\/dL) (without red blood cell transfusion <14 days prior to C1D1). Circulating lymphocytes less than or equal to (\u2264) 50*10^9\/L. Adequate liver and kidney function, defined as: Aspartate transaminase (AST) or alanine transaminase (ALT) \u22642.5*upper limit of normal (ULN), or \u22645*ULN in cases with known lymphoma involvement in the liver. Serum total bilirubin \u22642*ULN, or \u22645*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver. Calculated creatinine clearance (CrCl) \u226530 milliliter per minute (mL\/min) based on Cockcroft-Gault formula. Eastern Cooperative Oncology Group (ECOG) performance status of \u22642. An estimated life expectancy of >3 months at Screening. Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study. Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma. Previous treatment with selinexor or other XPO1 inhibitors. Contraindication to any drug contained in the combination therapy regimen (SR-GDP). Known active central nervous system or meningeal involvement by DLBCL at time of Screening. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions). Any AE, by C1D1, which has not recovered to Grade \u22641 (Common Terminology Criteria for Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia. Major surgery <14 days of Cycle 1 Day 1. Hematopoietic stem cell transplantation\/CAR-T therapy as follows: Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis) CAR-T cell infusion <90 days prior to Cycle 1 Neuropathy Grade \u22652 (CTCAE, v.5.0). Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections: Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units (IU)\/mL prior to first dose of study treatment. Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment. Breastfeeding or pregnant women. Inability or unwillingness to sign an informed consent form (ICF). In the opinion of the Investigator, patient who are significantly below their ideal body weight. Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.\"}","output":"{'Arm - Disease - Biomarker': 'Include: c-MYC, Bcl2 and\/or Bcl6 rearrangements'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Multicentric Randomized Phase I\/II Study to Evaluate Efficacy of Trifluridine\/Tipiracil Plus XB2001 (Anti-IL-1\u03b1 True Human Antibody) Versus Trifluridine\/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine\/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine\/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments. Based on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine\/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine\/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine\/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor. The project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms: Experimental arm: trifluridine\/tipiracil + XB2001 Control arm: trifluridine\/tipiracil + placebo', 'Inclusion Criteria': \"Inclusion Criteria: Male or female that must have signed a written informed consent prior to any study specific procedures Aged \u2265 18 years at randomization Patient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1\/PDL1 therapy) Have a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG) Knowledge of RAS, BRAF, Microsatellite status Baseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria. Patient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance. Adequat hepatic, renal and bone marrow function within the following limits: Total bilirubin \u2264 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome); ASAT et ALAT \u2264 5 times ULN; Measured Creatinine clearance (Cockcroft and Gault) > 30 ml \/ min Absolute Neutrophil Count (ANC) > 1,5. 109 \/ L; Platelet count \u2265 150. 109 \/ L; Haemoglobin \u2265 9 g \/ dL (patients can be included even if they have been transfused) Albuminemia \u2265 30 g \/ L; Negative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis Urea protein, urine dipstick should be less than 2 crossese or <1g\/kg Availability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides) Patient must be affiliated to a social health insurance Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion). Women of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment. Male patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment. Normal ECG or ECG without clinically significant findings with QTc < 470 ms.\", 'Exclusion Criteria': 'Exclusion Criteria: Other concurrent malignancies the last 3 years, except adequately treated cone-biopsied in situ carcinoma of the cervix, basal cell, squamous cell carcinoma of the skin or low risk prostate cancer. Patient who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for \u2265 5 years and the risk of recurrence is considered low. Symptomatic brain metastases Estimated prognosis <3 months. Mutational status BRAF mutant Participation in progress, or in the 30 days preceding the first scheduled day of dosing in this study, in another therapeutic trial with an experimental molecule or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer. Severe unbalanced illness, underlying infection that may prevent the patient from receiving treatment. Patients with a clinically important and unresolved Grade 3 or 4 non-haematologic adverse reaction related to previous therapies. Also participant with any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. Bowel obstruction or sub-obstruction or a history of inflammatory bowel disease or significant gasto intestinal disorder History of autoimmune or inflammatory disease or interstitial lung disease. Patient with congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome Severe arterial thromboembolic events less than 6 months before randomization New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as \u2265 160\/100 mm Hg) Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration. -Contraindication to receive a treatment with trifluridine\/tipiracil or an anti-IL-1\u03b1 (XB2001 True Human antibody) Concomitant systemic treatment with immunotherapy, immunosuppressants, corticosteroid therapy \u2265 10 mg equivalent prednisone\/prednisolone or hormone therapy: corticosteroid therapy administered chronically, immunosuppressive treatment, biotherapy administered as part of the management of an inflammatory disease (anti-TNF, anti-IL6, anti-IL1, anti PD-1, anti EGFR etc.) and live virus vaccines administered up to 14 days prior the first scheduled dose of treatement administration. Current pregnancy (mandatory pregnancy test at baseline for female of childbearing potential) or breastfeeding. Patient with any psychiatric, psychological, sociological, geographical problem or other severe concomitant disease, disorder or condition that potentially compromising the understanding of the information, the safety of the patient, the interpretation of study results or the conduct of the study compliance with the study protocol and follow-up schedule. Patient deprived of their liberty or under guardianship, curatorship or safeguard of justice. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever. Major surgery within 2 weeks prior to randomization or have an unhealed operation wounds.'}","output":"{'Arm - Disease - Biomarker': 'Exclude: Mutational status BRAF mutant'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Multicentric Randomized Phase I\/II Study to Evaluate Efficacy of Trifluridine\/Tipiracil Plus XB2001 (Anti-IL-1\u03b1 True Human Antibody) Versus Trifluridine\/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine\/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine\/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments. Based on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine\/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine\/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine\/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor. The project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms: Experimental arm: trifluridine\/tipiracil + XB2001 Control arm: trifluridine\/tipiracil + placebo', 'Inclusion Criteria': \"Inclusion Criteria: Male or female that must have signed a written informed consent prior to any study specific procedures Aged \u2265 18 years at randomization Patient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1\/PDL1 therapy) Have a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG) Knowledge of RAS, BRAF, Microsatellite status Baseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria. Patient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance. Adequat hepatic, renal and bone marrow function within the following limits: Total bilirubin \u2264 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome); ASAT et ALAT \u2264 5 times ULN; Measured Creatinine clearance (Cockcroft and Gault) > 30 ml \/ min Absolute Neutrophil Count (ANC) > 1,5. 109 \/ L; Platelet count \u2265 150. 109 \/ L; Haemoglobin \u2265 9 g \/ dL (patients can be included even if they have been transfused) Albuminemia \u2265 30 g \/ L; Negative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis Urea protein, urine dipstick should be less than 2 crossese or <1g\/kg Availability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides) Patient must be affiliated to a social health insurance Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion). Women of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment. Male patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment. Normal ECG or ECG without clinically significant findings with QTc < 470 ms.\", 'Exclusion Criteria': 'Exclusion Criteria: Other concurrent malignancies the last 3 years, except adequately treated cone-biopsied in situ carcinoma of the cervix, basal cell, squamous cell carcinoma of the skin or low risk prostate cancer. Patient who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for \u2265 5 years and the risk of recurrence is considered low. Symptomatic brain metastases Estimated prognosis <3 months. Mutational status BRAF mutant Participation in progress, or in the 30 days preceding the first scheduled day of dosing in this study, in another therapeutic trial with an experimental molecule or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer. Severe unbalanced illness, underlying infection that may prevent the patient from receiving treatment. Patients with a clinically important and unresolved Grade 3 or 4 non-haematologic adverse reaction related to previous therapies. Also participant with any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. Bowel obstruction or sub-obstruction or a history of inflammatory bowel disease or significant gasto intestinal disorder History of autoimmune or inflammatory disease or interstitial lung disease. Patient with congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome Severe arterial thromboembolic events less than 6 months before randomization New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as \u2265 160\/100 mm Hg) Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration. -Contraindication to receive a treatment with trifluridine\/tipiracil or an anti-IL-1\u03b1 (XB2001 True Human antibody) Concomitant systemic treatment with immunotherapy, immunosuppressants, corticosteroid therapy \u2265 10 mg equivalent prednisone\/prednisolone or hormone therapy: corticosteroid therapy administered chronically, immunosuppressive treatment, biotherapy administered as part of the management of an inflammatory disease (anti-TNF, anti-IL6, anti-IL1, anti PD-1, anti EGFR etc.) and live virus vaccines administered up to 14 days prior the first scheduled dose of treatement administration. Current pregnancy (mandatory pregnancy test at baseline for female of childbearing potential) or breastfeeding. Patient with any psychiatric, psychological, sociological, geographical problem or other severe concomitant disease, disorder or condition that potentially compromising the understanding of the information, the safety of the patient, the interpretation of study results or the conduct of the study compliance with the study protocol and follow-up schedule. Patient deprived of their liberty or under guardianship, curatorship or safeguard of justice. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever. Major surgery within 2 weeks prior to randomization or have an unhealed operation wounds.'}","output":"{'Arm - Disease - Biomarker': 'Exclude: Mutational status BRAF mutant'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2\/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: ECOG 0-1 Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 Adequate hematologic, hepatic and renal function (within 14 days)', 'Exclusion Criteria': 'Exclusion Criteria: Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) Indwelling surgical drains Grade 2 or higher QTc prolongation History of major organ transplant History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)'}","output":"{'Arm - Disease - Biomarker': 'Include: TP53WT'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria: Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required. Eastern Cooperative oncology group (ECOG) performance status of 0 or 1. At least 1 measurable lesion by RECIST 1.1', 'Exclusion Criteria': 'Exclusion criteria: Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways). Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1\u03b2 inhibitor). Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and\/or ALK rearrangement by locally approved laboratory testing. Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease. Subject with suspected or proven immune-compromised state or infections. Subject has prior to starting study drug: received live vaccination \u22643 months, had major surgery \u22644 weeks prior to starting study drug, has thoracic radiotherapy: lung fields \u2264 4 weeks, other anatomic sites \u2264 2 weeks, palliative radiotherapy for bone lesions \u2264 2 weeks.'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 status. Exclude: Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21),'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria: Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required. Eastern Cooperative oncology group (ECOG) performance status of 0 or 1. At least 1 measurable lesion by RECIST 1.1', 'Exclusion Criteria': 'Exclusion criteria: Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways). Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1\u03b2 inhibitor). Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and\/or ALK rearrangement by locally approved laboratory testing. Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease. Subject with suspected or proven immune-compromised state or infections. Subject has prior to starting study drug: received live vaccination \u22643 months, had major surgery \u22644 weeks prior to starting study drug, has thoracic radiotherapy: lung fields \u2264 4 weeks, other anatomic sites \u2264 2 weeks, palliative radiotherapy for bone lesions \u2264 2 weeks.'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 status. Exclude: Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21),'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b \u226510% 2+\/3+ tumor cell staining (FGFR2b \u226510% 2+\/3+TC)', 'Condition': 'Gastric Cancer Gastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy Fibroblast growth factor receptor 2b (FGFR2b) \u226510% 2+\/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months\/180 days prior to signing pre-screening informed consent) or a fresh biopsy Eastern Cooperative Oncology Group (ECOG) less than or equal to 1 Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1 Participant has no contraindications to mFOLFOX6 chemotherapy Adequate organ and bone marrow function: absolute neutrophil count greater than or equal to 1.5 times 10^9\/L platelet count greater than or equal to 100 times 10^9\/L hemoglobin \u2265 9 g\/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease) calculated or measured creatinine clearance (CrCl) of \u2265 30 mL\/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) \u00d7 Mass [kg]\/[72 \u00d7 Creatinine mg\/dL]) (x 0.85 if female) international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment\", 'Exclusion Criteria': 'Exclusion Criteria: Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment) Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway Known human epidermal growth factor receptor 2 (HER2) positive Untreated or symptomatic central nervous system (CNS) disease or brain metastases Peripheral sensory neuropathy greater than or equal to Grade 2 Clinically significant cardiac disease Other malignancy within the last 2 years (exceptions for definitively treated disease) Chronic or systemic ophthalmological disorders Major surgery or other investigational study within 28 days prior to first dose of study treatment Palliative radiotherapy within 14 days prior to the first dose of study treatment Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.'}","output":"{'Arm - Disease - Biomarker': 'Include: Fibroblast growth factor receptor 2b (FGFR2b) \u226510% 2+\/3+ tumor cell staining Exclude: Known human epidermal growth factor receptor 2 (HER2) positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b \u226510% 2+\/3+ tumor cell staining (FGFR2b \u226510% 2+\/3+TC)', 'Condition': 'Gastric Cancer Gastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy Fibroblast growth factor receptor 2b (FGFR2b) \u226510% 2+\/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months\/180 days prior to signing pre-screening informed consent) or a fresh biopsy Eastern Cooperative Oncology Group (ECOG) less than or equal to 1 Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1 Participant has no contraindications to mFOLFOX6 chemotherapy Adequate organ and bone marrow function: absolute neutrophil count greater than or equal to 1.5 times 10^9\/L platelet count greater than or equal to 100 times 10^9\/L hemoglobin \u2265 9 g\/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease) calculated or measured creatinine clearance (CrCl) of \u2265 30 mL\/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) \u00d7 Mass [kg]\/[72 \u00d7 Creatinine mg\/dL]) (x 0.85 if female) international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment\", 'Exclusion Criteria': 'Exclusion Criteria: Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment) Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway Known human epidermal growth factor receptor 2 (HER2) positive Untreated or symptomatic central nervous system (CNS) disease or brain metastases Peripheral sensory neuropathy greater than or equal to Grade 2 Clinically significant cardiac disease Other malignancy within the last 2 years (exceptions for definitively treated disease) Chronic or systemic ophthalmological disorders Major surgery or other investigational study within 28 days prior to first dose of study treatment Palliative radiotherapy within 14 days prior to the first dose of study treatment Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.'}","output":"{'Arm - Disease - Biomarker': 'Include: Fibroblast growth factor receptor 2b (FGFR2b) \u226510% 2+\/3+ tumor cell staining Exclude: Known human epidermal growth factor receptor 2 (HER2) positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer', 'Brief Summary': 'This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer', 'Condition': 'Pancreatic Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Informed consent has been signed Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer Age \u2265 18 years, \u226475 years, male or female ECOG PS\uff1a0-1, expected overall survival \u226512 months Patients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1\/2 germline mutations have previously received platinum-containing regimens Patients must have at least one measurable liver metastases (RECIST 1.1) No serious organic diseases of the heart, lungs, brain and other organs Patients must have adequate organ and bone marrow function Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration', 'Exclusion Criteria': 'Exclusion Criteria: Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment Previously received VEGFR inhibitors or immune checkpoint inhibitors Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ Patients previously had brain metastasis or current brain metastasis Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal\/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment Clinically significant electrolyte abnormality Patient currently has uncontrolled hypertension, defined as: systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg Proteinuria \u2265 2+ (1.0g\/24hr) Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study as judged by the investigator Have evidence or history of bleeding tendency within 3 months, significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification > 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval \u2265 480 ms Active or uncontrolled serious infection (\u2265CTCAE grade 2 infection) Unrelieved toxic reactions \u2265 CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of \u2264 grade 2 caused by oxaliplatin Pregnant or lactating women Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk Clinical confirmed human immunodeficiency virus (HIV) infection, history of clinically significant liver disease, including viral hepatitis (hepatitis B \/ C (HBV DNA Positive[1\u00d7104 copies\/mL or >2000 IU\/ml], HCV RNA positive[>1\u00d7103 copies\/mL]), or other hepatitis, cirrhosis]) Patients with autoimmune disease or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple Sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.) Patients who are allergic or suspected to be allergic to the study drug or similar drugs Patients have other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities. Accompanied by family or social factors, which will affect the safety of patients'}","output":"{'Arm - Disease - Biomarker': 'Include: BRCA1\/2 germline mutations'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)\/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry Participants must have: progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or; been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately', 'Exclusion Criteria': 'Exclusion Criteria: Prior treatment with either an immunotherapy or with regorafenib or with TAS-102 Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease\/pneumonitis or an active, known or suspected autoimmune disease Confirmed tumor microsatellite instable high\/deficient mismatch repair (MSI-H\/dMMR) status as per local standard testing; MSI\/MMR test results from initial diagnosis are acceptable.'}","output":"{'Arm - Disease - Biomarker': 'Include: evaluable PD-L1 expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)\/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry Participants must have: progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or; been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately', 'Exclusion Criteria': 'Exclusion Criteria: Prior treatment with either an immunotherapy or with regorafenib or with TAS-102 Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease\/pneumonitis or an active, known or suspected autoimmune disease Confirmed tumor microsatellite instable high\/deficient mismatch repair (MSI-H\/dMMR) status as per local standard testing; MSI\/MMR test results from initial diagnosis are acceptable.'}","output":"{'Arm - Disease - Biomarker': 'Include: evaluable PD-L1 expression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Volunteer to participate in clinical research; fully understand and know the research and sign informed consent; Age \u2265 18 years old and \u2264 75 years old, either sex; Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2; Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC; Have at least one measurable lesion as defined by RECIST 1.1; Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1; Patients without activating EGFR mutation; Normal hepatic function: total bilirubin\u22641.5\u00d7normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels \u22642.5\u00d7ULN or \u22645\u00d7ULN if liver metastasis is present; Normal renal function: Creatinine \u22641.5\u00d7ULN or calculated creatinine clearance \u226545 mL\/min (using Cockcroft\/Gault formula to calculate ); Normal hematological function: absolute neutrophil count \u22651.5\u00d7109\/L, platelet count \u226570\u00d7109\/L, hemoglobin\u226580g\/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency]; Has a life expectancy of at \u22653 months.', 'Exclusion Criteria': 'Exclusion Criteria: ECOG PS >2; Small cell lung cancer and squamous NSCLC; EGFR mutation or mutation status unknown; Known hypersensitivity or allergy to monoclonal antibody; Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); Active autoimmune disease, or a documented history of autoimmune disease; Treatment with systemic corticosteroids (prednisone\u226510mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose; Known history or active human immunodeficiency virus (HIV); Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection; Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment; Active or poorly controlled severe infection; Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization; Received thoracic radiation therapy of >30 Gy within 6 months prior to first dose of study drug; Completed palliative radiotherapy within 7 days prior to first dose of study drug; Pregnant or lactating women.'}","output":"{'Arm - Disease - Biomarker': 'Include: Wild type EGFR '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Volunteer to participate in clinical research; fully understand and know the research and sign informed consent; Age \u2265 18 years old and \u2264 75 years old, either sex; Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2; Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC; Have at least one measurable lesion as defined by RECIST 1.1; Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1; Patients without activating EGFR mutation; Normal hepatic function: total bilirubin\u22641.5\u00d7normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels \u22642.5\u00d7ULN or \u22645\u00d7ULN if liver metastasis is present; Normal renal function: Creatinine \u22641.5\u00d7ULN or calculated creatinine clearance \u226545 mL\/min (using Cockcroft\/Gault formula to calculate ); Normal hematological function: absolute neutrophil count \u22651.5\u00d7109\/L, platelet count \u226570\u00d7109\/L, hemoglobin\u226580g\/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency]; Has a life expectancy of at \u22653 months.', 'Exclusion Criteria': 'Exclusion Criteria: ECOG PS >2; Small cell lung cancer and squamous NSCLC; EGFR mutation or mutation status unknown; Known hypersensitivity or allergy to monoclonal antibody; Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); Active autoimmune disease, or a documented history of autoimmune disease; Treatment with systemic corticosteroids (prednisone\u226510mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose; Known history or active human immunodeficiency virus (HIV); Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection; Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment; Active or poorly controlled severe infection; Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization; Received thoracic radiation therapy of >30 Gy within 6 months prior to first dose of study drug; Completed palliative radiotherapy within 7 days prior to first dose of study drug; Pregnant or lactating women.'}","output":"{'Arm - Disease - Biomarker': 'Include: Wild type EGFR '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) \u2265 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) \u2265 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC. Have measurable disease as assessed by RECIST v1.1. Have confirmed PD-L1 TAP \u2265 10% in tumor tissues tested by the central lab. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.', 'Exclusion Criteria': 'Exclusion Criteria: Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. Participants with evidence of fistula (either esophageal\/bronchial or esophageal\/aorta). Evidence of complete esophageal obstruction not amenable to treatment. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention). Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 TAP \u2265 10% in tumor tissues'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) \u2265 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) \u2265 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC. Have measurable disease as assessed by RECIST v1.1. Have confirmed PD-L1 TAP \u2265 10% in tumor tissues tested by the central lab. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.', 'Exclusion Criteria': 'Exclusion Criteria: Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. Participants with evidence of fistula (either esophageal\/bronchial or esophageal\/aorta). Evidence of complete esophageal obstruction not amenable to treatment. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention). Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug'}","output":"{'Arm - Disease - Biomarker': 'Include: PD-L1 TAP \u2265 10% in tumor tissues'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 \/ ENGOT-ov43 \/ GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin\/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin\/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin\/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]\u226510) and in all participants, and that the combination of pembrolizumab plus carboplatin\/paclitaxel followed by continued pembrolizumab is superior to carboplatin\/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS\u226510) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': \"Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin\/paclitaxel*, participants will be randomly assigned in to one of three treatment arms: Pembrolizumab + Olaparib, Pembrolizumab + Placebo for Olaparib Placebo for Pembrolizumab + Placebo for Olaparib At Investigator's discretion and prior to participant randomization, one of the following carboplatin\/paclitaxel regimens is to be selected: up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg\/m^2 on Day 1 of each 3-week cycle up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle; or up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle. Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg\/m^2 Q3W plus carboplatin AUC 5 Q3W.\", 'Inclusion Criteria': 'Inclusion Criteria: Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits\/L):carcinoembryonic antigen (CEA; ng\/mL) ratio greater than or equal to 25 Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1\/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1 Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze\/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Has adequate organ function', 'Exclusion Criteria': \"Exclusion Criteria: Has mucinous, germ cell, or borderline tumor of the ovary Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2 Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis Has either myelodysplastic syndrome (MDS)\/acute myeloid leukemia (AML) or has features suggestive of MDS\/AML Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period Has known active central nervous system metastases and\/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Has a known history of active tuberculosis (TB; Bacillus Tuberculosis) Has an active infection requiring systemic therapy Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening Has a known history of human immunodeficiency virus (HIV) infection Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption) Has uncontrolled hypertension Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab) Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab) Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy) Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137) Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor Has intraperitoneal chemotherapy planned or has been administered as first-line therapy Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1 Has severe hypersensitivity (\u2265Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and\/or any of their excipients Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome Has had an allogenic tissue\/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery\"}","output":"{'Arm - Disease - Biomarker': 'BRCA Non-mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 \/ ENGOT-ov43 \/ GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin\/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin\/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin\/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]\u226510) and in all participants, and that the combination of pembrolizumab plus carboplatin\/paclitaxel followed by continued pembrolizumab is superior to carboplatin\/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS\u226510) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': \"Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin\/paclitaxel*, participants will be randomly assigned in to one of three treatment arms: Pembrolizumab + Olaparib, Pembrolizumab + Placebo for Olaparib Placebo for Pembrolizumab + Placebo for Olaparib At Investigator's discretion and prior to participant randomization, one of the following carboplatin\/paclitaxel regimens is to be selected: up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg\/m^2 on Day 1 of each 3-week cycle up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle; or up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle. Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg\/m^2 Q3W plus carboplatin AUC 5 Q3W.\", 'Inclusion Criteria': 'Inclusion Criteria: Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits\/L):carcinoembryonic antigen (CEA; ng\/mL) ratio greater than or equal to 25 Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1\/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1 Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze\/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Has adequate organ function', 'Exclusion Criteria': \"Exclusion Criteria: Has mucinous, germ cell, or borderline tumor of the ovary Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2 Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis Has either myelodysplastic syndrome (MDS)\/acute myeloid leukemia (AML) or has features suggestive of MDS\/AML Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period Has known active central nervous system metastases and\/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Has a known history of active tuberculosis (TB; Bacillus Tuberculosis) Has an active infection requiring systemic therapy Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening Has a known history of human immunodeficiency virus (HIV) infection Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption) Has uncontrolled hypertension Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab) Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab) Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy) Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137) Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor Has intraperitoneal chemotherapy planned or has been administered as first-line therapy Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1 Has severe hypersensitivity (\u2265Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and\/or any of their excipients Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome Has had an allogenic tissue\/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery\"}","output":"{'Arm - Disease - Biomarker': 'BRCA Non-mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 \/ ENGOT-ov43 \/ GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin\/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin\/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin\/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]\u226510) and in all participants, and that the combination of pembrolizumab plus carboplatin\/paclitaxel followed by continued pembrolizumab is superior to carboplatin\/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS\u226510) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': \"Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin\/paclitaxel*, participants will be randomly assigned in to one of three treatment arms: Pembrolizumab + Olaparib, Pembrolizumab + Placebo for Olaparib Placebo for Pembrolizumab + Placebo for Olaparib At Investigator's discretion and prior to participant randomization, one of the following carboplatin\/paclitaxel regimens is to be selected: up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg\/m^2 on Day 1 of each 3-week cycle up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle; or up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg\/m^2 on Days 1, 8 and 15 of each 3-week cycle. Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg\/m^2 Q3W plus carboplatin AUC 5 Q3W.\", 'Inclusion Criteria': 'Inclusion Criteria: Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits\/L):carcinoembryonic antigen (CEA; ng\/mL) ratio greater than or equal to 25 Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1\/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1 Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze\/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Has adequate organ function', 'Exclusion Criteria': \"Exclusion Criteria: Has mucinous, germ cell, or borderline tumor of the ovary Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2 Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis Has either myelodysplastic syndrome (MDS)\/acute myeloid leukemia (AML) or has features suggestive of MDS\/AML Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period Has known active central nervous system metastases and\/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Has a known history of active tuberculosis (TB; Bacillus Tuberculosis) Has an active infection requiring systemic therapy Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening Has a known history of human immunodeficiency virus (HIV) infection Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption) Has uncontrolled hypertension Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab) Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab) Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy) Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137) Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor Has intraperitoneal chemotherapy planned or has been administered as first-line therapy Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1 Has severe hypersensitivity (\u2265Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and\/or any of their excipients Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome Has had an allogenic tissue\/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery\"}","output":"{'Arm - Disease - Biomarker': 'BRCA Non-mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the EGFR inhibitor, Cetuximab in patients with mCRC harboring APC, TP53 and RAS mutations.', 'Condition': 'Colorectal Cancer', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Male or female subject aged \u2265 18 years. Histologically confirmed metastatic colorectal adenocarcinoma with mutant APC, TP53 and KRAS genes as determined by the local CLIA-certified laboratory are eligible. All RAS mutations are allowed (KRAS, NRAS, HRAS). Patients with wild type KRAS, APC or TP53 are ineligible.. Progression or unwanted toxicities on atleast 2 prior lines of treatment including 5-Flourouracil, oxaliplatin and irinotecan based regimen Study participants must have measurable disease by RECIST 1.1 criteria by CT or MRI. ECOG Performance Status \u2264 2. Study participants with treated and\/or stable brain metastases are allowed Study participants must have anticipated life expectancy > 3 months Adequate organ function as defined as: Hematologic: Absolute neutrophil count (ANC) \u2265 \u22651000\/\u00b5L Platelet count \u2265 100,000\/mm3 Hemoglobin \u2265 9 g\/dL Hepatic: Serum Bilirubin \u2264 2 x ULN or \u2264 3 x ULN for subjects with Gilbert's syndrome Aspartate transaminase (AST) and alanine transaminase (ALT) \u2264 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases) Renal: Serum creatinine \u22641.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) \u226540 mL\/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women < 50 years of age: Amenorrheic for \u2265 12 months following cessation of exogenous hormonal treatments; and Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy). Women \u2265 50 years of age: Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or Had radiation-induced menopause with last menses >1 year ago; or Had chemotherapy-induced menopause with last menses >1 year ago; or Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 12 months after last study treatment administration. Male subjects must agree to use a condom during intercourse for the duration of study therapy and for atleast 12 months after last study treatment administration. Recovery to baseline or \u2264 Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\", 'Exclusion Criteria': \"Exclusion Criteria: Prior use of systemic anti-EGFR therapy including cetuximab or panitumumab is not allowed but prior use irinotecan, oxaliplatin, regorafenib or TAS-102 is allowed Study participants with prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen, as determined by the investigator Study participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease who need immediate CNS specific treatment during first cycle of treatment as determined by the treating physician. --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions: The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency. The patient has uncontrolled or poorly-controlled hypertension (>180 mmHg systolic or > 130 mmHg diastolic. Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social\/ psychological issues, etc.) Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. --Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study. Known prior severe hypersensitivity attributed to compounds of chemical or biologic composition similar to those of cetuximab, or if the patient had red meat allergy\/tick bite history (NCI CTCAE v5.0 Grade \u2265 3). Live attenuated and inactive vaccinations within 4 weeks of the first dose of study treatment and while on trial is prohibited. COVID-19 vaccines are allowed The patient is pregnant or breast-feeding.\"}","output":"{'Arm - Disease - Biomarker': 'Include: Mutant APC, TP53 and KRAS genes, RAS mutations are allowed (KRAS, NRAS, HRAS). Exlcude: wild type KRAS'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation. ', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma. ', 'Condition': 'Biliary Carcinoma ', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: age \u226518 years old, \u226475 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2. Tumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections). Patients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period. The main organs have good functions. Meet the criteria for advanced biliary carcinoma: cholangiocarcinoma histologically or cytologically confirmed Locally advanced, relapsing, and\/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria. Previous gemcitabine and fluorouracil (and\/or platinum-based) drug therapy failed. Women of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.', 'Exclusion Criteria': \"Exclusion Criteria: Complicated diseases and medical history. The patient had or was currently present with other malignant tumors within 3 years prior to the first medication. Unmitigated toxic reactions above class 1 of Common Terminology Criteria for Adverse Events V5.0 (CTCAE) due to any previous treatment, excluding hair loss; Received major surgical treatment, significant traumatic injury, or long-standing unhealed wounds or fractures within 4 weeks prior to initial medication; Patients with any bleeding or bleeding events \u2265CTCAE grade 3 within 4 weeks prior to initial administration; Patients with arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism, occurring within 6 months prior to initial administration; Treatment with low molecular weight heparin was allowed and antiplatelet drugs were prohibited throughout the study; There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms; Those who have the history of psychotropic drug abuse and cannot abstain or have mental disorders; Those who plan to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation; A history of hepatic encephalopathy; Current or recent use (within 7 days prior to the start of study treatment) of aspirin (>325 mg\/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; Subjects with any severe and\/or uncontrolled medical conditions, including: Poor blood pressure control (systolic blood pressure \u2265150 mmHg or diastolic blood pressure \u2265100 mmHg); have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including Corrected Q-T interval (QTC) \u2265 450ms in men and 470ms in women), and grade 2 congestive heart failure (New York Heart Association (NYHA) rating); Active or uncontrolled severe infection (\u2265CTCAE grade 2 infection); Patients with renal failure requiring hemodialysis or peritoneal dialysis; A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases; People who have epilepsy and need treatment. Tumor related and treatment: Hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, etc. confirmed by histology or cytology; According to imaging examination, cancer thrombus of the portal vein involved both the main trunk and the left and right primary branches, or involved both the main trunk and above veins (superior mesenteric vein, inferior mesenteric vein, spleen vein), or had cancer thrombus of the inferior vena cava or involved the heart; Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage (the investigator's judgment); Known spinal cord compression, cancerous meningitis, symptoms of brain metastases, or symptoms controlled for less than 4 weeks. Research and treatment related: Known allergy to study drug excipients. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it within 7 days prior to initial administration (except for those whose daily dose of corticosteroids is less than 10 mg prednisone or other therapeutic hormones). Patients who participated in and used other antitumor clinical trials within 4 weeks before the first drug administration; According to the judgment of the researcher, there is any situation that seriously endangers the safety of the subject or affects the completion of the study.\"}","output":"{'Arm - Disease - Biomarker': 'IDH1 Mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation. ', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma. ', 'Condition': 'Biliary Carcinoma ', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: age \u226518 years old, \u226475 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2. Tumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections). Patients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period. The main organs have good functions. Meet the criteria for advanced biliary carcinoma: cholangiocarcinoma histologically or cytologically confirmed Locally advanced, relapsing, and\/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria. Previous gemcitabine and fluorouracil (and\/or platinum-based) drug therapy failed. Women of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.', 'Exclusion Criteria': \"Exclusion Criteria: Complicated diseases and medical history. The patient had or was currently present with other malignant tumors within 3 years prior to the first medication. Unmitigated toxic reactions above class 1 of Common Terminology Criteria for Adverse Events V5.0 (CTCAE) due to any previous treatment, excluding hair loss; Received major surgical treatment, significant traumatic injury, or long-standing unhealed wounds or fractures within 4 weeks prior to initial medication; Patients with any bleeding or bleeding events \u2265CTCAE grade 3 within 4 weeks prior to initial administration; Patients with arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism, occurring within 6 months prior to initial administration; Treatment with low molecular weight heparin was allowed and antiplatelet drugs were prohibited throughout the study; There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms; Those who have the history of psychotropic drug abuse and cannot abstain or have mental disorders; Those who plan to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation; A history of hepatic encephalopathy; Current or recent use (within 7 days prior to the start of study treatment) of aspirin (>325 mg\/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; Subjects with any severe and\/or uncontrolled medical conditions, including: Poor blood pressure control (systolic blood pressure \u2265150 mmHg or diastolic blood pressure \u2265100 mmHg); have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including Corrected Q-T interval (QTC) \u2265 450ms in men and 470ms in women), and grade 2 congestive heart failure (New York Heart Association (NYHA) rating); Active or uncontrolled severe infection (\u2265CTCAE grade 2 infection); Patients with renal failure requiring hemodialysis or peritoneal dialysis; A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases; People who have epilepsy and need treatment. Tumor related and treatment: Hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, etc. confirmed by histology or cytology; According to imaging examination, cancer thrombus of the portal vein involved both the main trunk and the left and right primary branches, or involved both the main trunk and above veins (superior mesenteric vein, inferior mesenteric vein, spleen vein), or had cancer thrombus of the inferior vena cava or involved the heart; Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage (the investigator's judgment); Known spinal cord compression, cancerous meningitis, symptoms of brain metastases, or symptoms controlled for less than 4 weeks. Research and treatment related: Known allergy to study drug excipients. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it within 7 days prior to initial administration (except for those whose daily dose of corticosteroids is less than 10 mg prednisone or other therapeutic hormones). Patients who participated in and used other antitumor clinical trials within 4 weeks before the first drug administration; According to the judgment of the researcher, there is any situation that seriously endangers the safety of the subject or affects the completion of the study.\"}","output":"{'Arm - Disease - Biomarker': 'IDH1 Mutated'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and\/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Brief Summary': \"This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and\/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer. \", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant ', 'Detailed Description': 'PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of nivolumab\/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection. SECONDARY OBJECTIVES: I. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG. II. To determine whether nivolumab\/ipilimumab and\/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG. OUTLINE: Patients are sequentially assigned to 2 cohorts. COHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms. ARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection. ARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. ARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection. COHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms. ARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. ARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria: Participants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study All participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction Participants must undergo human leukocyte antigen (HLA) testing A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial Have unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment An interval of the following durations prior to enrollment: At least 14 days from prior surgical resection At least 7 days from prior stereotactic biopsy At least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression At least 23 days from prior chemotherapy At least 42 days from nitrosureas Have sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick) Have a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16 Absolute neutrophil count (ANC) >= 1500\/uL (within 14 days prior to start of study treatment) Platelets >= 100 000\/uL (microliter) (within 14 days prior to the start of study treatment) Hemoglobin >= 9.0 g\/dL or >= 5.6 mmol\/L (within 14 days prior to the start of study treatment) Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL\/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment) Note: Creatinine clearance (CrCl) should be calculated per institutional standard Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment) International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)', 'Exclusion Criteria': \"Exclusion Criteria: Age < 13 years or > 60 years Have had more than 2 separately-treated recurrences of the index tumor A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory target (e.g., CTLA-4, OX 40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgical resection, they must have recovered adequately from the toxicity and\/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 12 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 12 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg\/kg\/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and\/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Has a known history of active tuberculosis (bacillus tuberculosis) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Kidney dysfunction precluding administration of gadolinium-based contrast Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\"}","output":"{'Arm - Disease - Biomarker': 'H3 G34 Mutant '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) ', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo) ', 'Condition': 'Gastro-Oesophageal Cancer ', 'Detailed Description': 'Purpose: The purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma. Who is it for: You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy. Trial Details: Participants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria Adults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which: has arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and is of adenocarcinoma or undifferentiated carcinoma histology , and is evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and has failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent\/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue. Note: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment. HER2-positive participants must have received trastuzumab. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Ability to swallow oral medication. Adequate bone marrow function (Platelets \u2265100x109\/L; Absolute Neutrophil Count (ANC) \u22651.5x109\/L and Haemoglobin \u2265 9.0g\/dL). Adequate renal function (Creatinine clearance >50 ml\/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine \u22641.5 x Upper Limit of Normal (ULN). Adequate liver function (Serum total bilirubin \u22641.5 x ULN, and INR \u2264 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) \u22642.5 x ULN (\u2264 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists. Adequate cardiac function (Left Ventricular Ejection Fraction (LVEF) \u2265 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy. Willing and able to comply with all study requirements, including treatment, timing, and\/or nature of required assessments and follow-up. Study treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday). Signed, written informed consent.', 'Exclusion Criteria': 'Exclusion Criteria Known allergy to the investigational product drug class or excipients in the regorafenib. Poorly-controlled hypertension (systolic blood pressure >140mmHg or diastolic pressure> 90mmHg despite optimal medical management). Participants with known, uncontrolled malabsorption syndromes. Any prior anti-VEGF targeted therapy using small molecule VEGF TKIs (e.g. apatinib). Prior anti-VEGF targeted monoclonal antibody therapies (e.g. bevacizumab and ramucirumab) are permitted. Treatment with any previous drug therapy within 2 weeks prior to first dose of study treatment. This includes any investigational therapy. Use of biological response modifiers, such as granulocyte colony stimulating factor (G-CSF), within 3 weeks prior to randomisation. Concurrent treatment with strong CYP3A4 inhibitors or inducers. Palliative radiotherapy, unless more than 14 days have elapsed between completion of radiation and the date of registration, and adverse events resulting from radiation have resolved to< Grade 2 according to CTCAE V4.03. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization. Arterial thrombotic or ischaemic events, such as cerebrovascular accident, within 6 months prior to randomization. Venous thrombotic events and pulmonary embolism within 3 months prior to randomization. Any haemorrhage or bleeding event \u2265 Grade 3 according to CTCAE v4.03 within 4 weeks prior to randomization. Non-healing wound, ulcer, or bone fracture. Interstitial lung disease with ongoing signs and symptoms. Clinical hyperthyroidism or hypothyroidism. Note: non-clinically significant abnormal TFTs (abnormal TSH and abnormal T3 and\/or abnormal T4) considered to be due to sick euthyroid syndrome is allowed. Persistent proteinuria of \u2265 Grade 3 according to CTCAE v4.03 (equivalent to > 3.5g of protein over 24 hours, measured on either a random specimen or 24 hour collection). Uncontrolled metastatic disease to the central nervous system. To be eligible, CNS metastases should have been treated with surgery and\/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomization, with no deterioration in neurological symptoms during this time. History of another malignancy within 2 years prior to randomization. Participants with the following are eligible for this study: curatively treated cervical carcinoma in situ, non-melanomatous carcinoma of the skin, superficial bladder tumours (T1a [Non-invasive tumour], and Tis[Carcinoma in situ]), treated thyroid papillary cancer Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known Hepatitis B\/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy. Serious medical or psychiatric condition(s) that might limit the ability of the patient to comply with the protocol. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomization. Men must have been surgically sterilized or use a barrier method of contraception'}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-positive participants who have received trastuzumab'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) ', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo) ', 'Condition': 'Gastro-Oesophageal Cancer ', 'Detailed Description': 'Purpose: The purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma. Who is it for: You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy. Trial Details: Participants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria Adults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which: has arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and is of adenocarcinoma or undifferentiated carcinoma histology , and is evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and has failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent\/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue. Note: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment. HER2-positive participants must have received trastuzumab. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Ability to swallow oral medication. Adequate bone marrow function (Platelets \u2265100x109\/L; Absolute Neutrophil Count (ANC) \u22651.5x109\/L and Haemoglobin \u2265 9.0g\/dL). Adequate renal function (Creatinine clearance >50 ml\/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine \u22641.5 x Upper Limit of Normal (ULN). Adequate liver function (Serum total bilirubin \u22641.5 x ULN, and INR \u2264 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) \u22642.5 x ULN (\u2264 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists. Adequate cardiac function (Left Ventricular Ejection Fraction (LVEF) \u2265 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy. Willing and able to comply with all study requirements, including treatment, timing, and\/or nature of required assessments and follow-up. Study treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday). Signed, written informed consent.', 'Exclusion Criteria': 'Exclusion Criteria Known allergy to the investigational product drug class or excipients in the regorafenib. Poorly-controlled hypertension (systolic blood pressure >140mmHg or diastolic pressure> 90mmHg despite optimal medical management). Participants with known, uncontrolled malabsorption syndromes. Any prior anti-VEGF targeted therapy using small molecule VEGF TKIs (e.g. apatinib). Prior anti-VEGF targeted monoclonal antibody therapies (e.g. bevacizumab and ramucirumab) are permitted. Treatment with any previous drug therapy within 2 weeks prior to first dose of study treatment. This includes any investigational therapy. Use of biological response modifiers, such as granulocyte colony stimulating factor (G-CSF), within 3 weeks prior to randomisation. Concurrent treatment with strong CYP3A4 inhibitors or inducers. Palliative radiotherapy, unless more than 14 days have elapsed between completion of radiation and the date of registration, and adverse events resulting from radiation have resolved to< Grade 2 according to CTCAE V4.03. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization. Arterial thrombotic or ischaemic events, such as cerebrovascular accident, within 6 months prior to randomization. Venous thrombotic events and pulmonary embolism within 3 months prior to randomization. Any haemorrhage or bleeding event \u2265 Grade 3 according to CTCAE v4.03 within 4 weeks prior to randomization. Non-healing wound, ulcer, or bone fracture. Interstitial lung disease with ongoing signs and symptoms. Clinical hyperthyroidism or hypothyroidism. Note: non-clinically significant abnormal TFTs (abnormal TSH and abnormal T3 and\/or abnormal T4) considered to be due to sick euthyroid syndrome is allowed. Persistent proteinuria of \u2265 Grade 3 according to CTCAE v4.03 (equivalent to > 3.5g of protein over 24 hours, measured on either a random specimen or 24 hour collection). Uncontrolled metastatic disease to the central nervous system. To be eligible, CNS metastases should have been treated with surgery and\/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomization, with no deterioration in neurological symptoms during this time. History of another malignancy within 2 years prior to randomization. Participants with the following are eligible for this study: curatively treated cervical carcinoma in situ, non-melanomatous carcinoma of the skin, superficial bladder tumours (T1a [Non-invasive tumour], and Tis[Carcinoma in situ]), treated thyroid papillary cancer Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known Hepatitis B\/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy. Serious medical or psychiatric condition(s) that might limit the ability of the patient to comply with the protocol. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomization. Men must have been surgically sterilized or use a barrier method of contraception'}","output":"{'Arm - Disease - Biomarker': 'Include: HER2-positive participants who have received trastuzumab'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB\/C BRAF V600E\/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E\/K mutant stage IIB\/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial. Participants with completely resected cutaneous melanoma and documented BRAF V600E\/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between: stage IIB (i.e., pT3b or pT4a) stage IIC (i.e., pT4b). The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': \"Inclusion Criteria: Pre-Screening Male or female \u2265 18 years of age; Surgically resected, with tumour free margins, and histologically\/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa; Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma. Sentinel node (SN) staged node negative (pN0); Available tumour sample for central determination of the BRAF V600E\/K mutation. Screening Melanoma confirmed centrally to be BRAF V600E\/K mutation-positive; Participant still free of disease as evidenced by the required baseline imaging and physical\/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1); No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization; Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains); ECOG performance status of 0 or 1; Adequate haematological function as defined as Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L, Platelets \u2265 100 x 109\/L and Hemoglobin \u2265 9.0 g\/dL; Adequate renal function as defined as Serum creatinine \u2264 1.5 \u00d7 ULN; or calculated creatinine clearance \u2265 50 mL\/min; Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits; Adequate hepatic function as defined as Serum total bilirubin \u2264 1.5 x ULN and < 2 mg\/dL, Alanine aminotransferase (ALT) and\/or aspartate aminotransferase (AST) \u2264 2.5 x ULN; Adequate cardiac function as defined as LVEF \u2265 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value \u2264 480 msec and no history of QT syndrome; Adequate coagulation function, defined as INR \u22641.5\u00d7 ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range; Negative serum \u03b2-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1; Female patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for \u226530 days after last administration.\", 'Exclusion Criteria': 'Exclusion Criteria: Pre-screening Unknown ulceration status; Uveal and mucosal melanoma; Clinically apparent metastases (N+\/M1); Microsatellites, satellites and\/or in-transit metastases, Local (scar) recurrences. Screening Breast feeding women; Pregnant women; History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; History of thromboembolic or cerebrovascular events \u2264 12 weeks prior to randomization; History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years; Participants with a prior cancer associated with RAS mutation; Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma; Hypersensitivity to the study drugs or to any of the excipients; Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption); Impaired cardiovascular function or clinically significant cardiovascular diseases; Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy); Non-infectious pneumonitis and Interstitial Lung Disease; Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending; Active bacterial, fungal, or viral infection, including, but not limited to HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.'}","output":"{'Arm - Disease - Biomarker': 'BRAF V600E\/K mutation-positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB\/C BRAF V600E\/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E\/K mutant stage IIB\/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial. Participants with completely resected cutaneous melanoma and documented BRAF V600E\/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between: stage IIB (i.e., pT3b or pT4a) stage IIC (i.e., pT4b). The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': \"Inclusion Criteria: Pre-Screening Male or female \u2265 18 years of age; Surgically resected, with tumour free margins, and histologically\/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa; Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma. Sentinel node (SN) staged node negative (pN0); Available tumour sample for central determination of the BRAF V600E\/K mutation. Screening Melanoma confirmed centrally to be BRAF V600E\/K mutation-positive; Participant still free of disease as evidenced by the required baseline imaging and physical\/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1); No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization; Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains); ECOG performance status of 0 or 1; Adequate haematological function as defined as Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L, Platelets \u2265 100 x 109\/L and Hemoglobin \u2265 9.0 g\/dL; Adequate renal function as defined as Serum creatinine \u2264 1.5 \u00d7 ULN; or calculated creatinine clearance \u2265 50 mL\/min; Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits; Adequate hepatic function as defined as Serum total bilirubin \u2264 1.5 x ULN and < 2 mg\/dL, Alanine aminotransferase (ALT) and\/or aspartate aminotransferase (AST) \u2264 2.5 x ULN; Adequate cardiac function as defined as LVEF \u2265 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value \u2264 480 msec and no history of QT syndrome; Adequate coagulation function, defined as INR \u22641.5\u00d7 ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range; Negative serum \u03b2-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1; Female patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for \u226530 days after last administration.\", 'Exclusion Criteria': 'Exclusion Criteria: Pre-screening Unknown ulceration status; Uveal and mucosal melanoma; Clinically apparent metastases (N+\/M1); Microsatellites, satellites and\/or in-transit metastases, Local (scar) recurrences. Screening Breast feeding women; Pregnant women; History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; History of thromboembolic or cerebrovascular events \u2264 12 weeks prior to randomization; History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years; Participants with a prior cancer associated with RAS mutation; Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma; Hypersensitivity to the study drugs or to any of the excipients; Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption); Impaired cardiovascular function or clinically significant cardiovascular diseases; Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy); Non-infectious pneumonitis and Interstitial Lung Disease; Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending; Active bacterial, fungal, or viral infection, including, but not limited to HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.'}","output":"{'Arm - Disease - Biomarker': 'BRAF V600E\/K mutation-positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H\/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate. Metastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': \"Inclusion Criteria: Provide written informed consent; Age \u226518 years; Histologically and\/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)\/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines; Participants must have progressed on or been intolerant to treatment with either trifluridine\/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy; Participants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor; Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible; Body weight \u226540kg; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Have measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions; Expected survival >12 weeks. For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen\/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom. Participants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.\", 'Exclusion Criteria': \"Exclusion Criteria: Absolute neutrophil count (ANC) <1.5\u00d7109\/L, platelet count <100\u00d7109\/L, or hemoglobin <9.0 g\/dL. Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed; Serum total bilirubin >1.5 \u00d7 the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin <2 X ULN, and normal AST\/ALT are eligible; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 \u00d7 ULN in participants without hepatic metastases; ALT or AST >5 \u00d7 ULN in participants with hepatic metastases; Serum creatinine >1.5 \u00d7 ULN or creatinine clearance <60 mL\/min. Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockroft-Gault equation. Urine dipstick protein \u22652+ or 24-hour urine protein \u22651.0 g\/24-h. Participants with greater than 2+ proteinuria by dipstick must undergo a 24-hour urine collection to assess urine protein level; Uncontrolled hypertension, defined as: systolic blood pressure \u2265140 mm Hg and\/or diastolic blood pressure \u226590 mm Hg despite optimal medical management. Participants were required to have blood pressure values below both limits. Repeated assessments were permitted; International Normalized Ratio (INR) >1.5 x ULN or activated partial thromboplastin time (aPTT) >1.5 \u00d7 ULN, unless the patient is currently receiving or intended to receive anticoagulants for prophylactic purposes; History of, or active gastric\/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas; or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation; within the 6 months prior to screening; History or presence of hemorrhage from any other site (eg, hemoptysis or hematemesis) within 2 months prior to screening; History of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within 6 months prior to screening. Stroke and\/or transient ischemic attack within 12 months prior to screening; Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III\/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50% by echocardiogram; Mean corrected QT interval using the Fridericia method (QTcF) >480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative. Concomitant medications with a known risk of causing QT prolongation and\/or Torsades de Pointes. Systemic anti-neoplastic therapies (except for those described in Exclusion 18) or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy; Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug; Palliative radiotherapy for bone metastasis\/lesion within 2 weeks prior to the initiation of study drug; Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of study drug. Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug; Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 60 days prior to the first dose of study drug or unhealed surgical incision; Any unresolved toxicities from a previous antitumor treatment greater than CTCAE v5.0 Grade 1 (except for alopecia or neurotoxicity grade\u22642); Known human immunodeficiency virus (HIV) infection; Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load. Clinically uncontrolled active infection requiring IV antibiotics; Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava; Women who are pregnant or lactating; Brain metastases and\/or spinal cord compression untreated with surgery and\/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; participants requiring steroids within 4 weeks prior to start of study treatment are excluded; Other malignancy, except for non-melanoma skin cancer, in situ cervical ca or bladder ca (Tis and T1) that have been adequately treated during the 5 years prior to screening; Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product; Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment; Known hypersensitivity to fruquintinib (or placebo) or any of its inactive ingredients including the azo dyes Tartrazine - FD&C Yellow 5 and Sunset yellow FCF - FD&C Yellow 6; Participants who have received prior fruquintinib; Live vaccine <28days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\"}","output":"{'Arm - Disease - Biomarker': 'RAS, BRAF, MSI, MMR'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H\/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate. Metastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': \"Inclusion Criteria: Provide written informed consent; Age \u226518 years; Histologically and\/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)\/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines; Participants must have progressed on or been intolerant to treatment with either trifluridine\/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy; Participants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor; Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible; Body weight \u226540kg; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Have measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions; Expected survival >12 weeks. For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen\/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom. Participants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.\", 'Exclusion Criteria': \"Exclusion Criteria: Absolute neutrophil count (ANC) <1.5\u00d7109\/L, platelet count <100\u00d7109\/L, or hemoglobin <9.0 g\/dL. Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed; Serum total bilirubin >1.5 \u00d7 the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin <2 X ULN, and normal AST\/ALT are eligible; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 \u00d7 ULN in participants without hepatic metastases; ALT or AST >5 \u00d7 ULN in participants with hepatic metastases; Serum creatinine >1.5 \u00d7 ULN or creatinine clearance <60 mL\/min. Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockroft-Gault equation. Urine dipstick protein \u22652+ or 24-hour urine protein \u22651.0 g\/24-h. Participants with greater than 2+ proteinuria by dipstick must undergo a 24-hour urine collection to assess urine protein level; Uncontrolled hypertension, defined as: systolic blood pressure \u2265140 mm Hg and\/or diastolic blood pressure \u226590 mm Hg despite optimal medical management. Participants were required to have blood pressure values below both limits. Repeated assessments were permitted; International Normalized Ratio (INR) >1.5 x ULN or activated partial thromboplastin time (aPTT) >1.5 \u00d7 ULN, unless the patient is currently receiving or intended to receive anticoagulants for prophylactic purposes; History of, or active gastric\/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas; or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation; within the 6 months prior to screening; History or presence of hemorrhage from any other site (eg, hemoptysis or hematemesis) within 2 months prior to screening; History of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within 6 months prior to screening. Stroke and\/or transient ischemic attack within 12 months prior to screening; Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III\/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50% by echocardiogram; Mean corrected QT interval using the Fridericia method (QTcF) >480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative. Concomitant medications with a known risk of causing QT prolongation and\/or Torsades de Pointes. Systemic anti-neoplastic therapies (except for those described in Exclusion 18) or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy; Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug; Palliative radiotherapy for bone metastasis\/lesion within 2 weeks prior to the initiation of study drug; Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of study drug. Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug; Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 60 days prior to the first dose of study drug or unhealed surgical incision; Any unresolved toxicities from a previous antitumor treatment greater than CTCAE v5.0 Grade 1 (except for alopecia or neurotoxicity grade\u22642); Known human immunodeficiency virus (HIV) infection; Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load. Clinically uncontrolled active infection requiring IV antibiotics; Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava; Women who are pregnant or lactating; Brain metastases and\/or spinal cord compression untreated with surgery and\/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; participants requiring steroids within 4 weeks prior to start of study treatment are excluded; Other malignancy, except for non-melanoma skin cancer, in situ cervical ca or bladder ca (Tis and T1) that have been adequately treated during the 5 years prior to screening; Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product; Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment; Known hypersensitivity to fruquintinib (or placebo) or any of its inactive ingredients including the azo dyes Tartrazine - FD&C Yellow 5 and Sunset yellow FCF - FD&C Yellow 6; Participants who have received prior fruquintinib; Live vaccine <28days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\"}","output":"{'Arm - Disease - Biomarker': 'RAS, BRAF, MSI, MMR'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4\/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers ', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer. ', 'Condition': 'Metastatic Colorectal Carcinoma Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Unresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE: I. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib\/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC). SECONDARY OBJECTIVES: I. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib\/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC. II. To compare the overall survival (OS) between those randomized to palbociclib\/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC. III. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC. CORRELATIVE RESEARCH OBJECTIVES: I. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib\/binimetinib. II. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib\/binimetinib or TAS-102. III. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib\/binimetinib. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A. After completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria: Histological confirmation of colorectal cancer that is metastatic and\/or unresectable Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy Absolute neutrophil count (ANC) >= 1.5 x 10^9\/L (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Platelet count >= 75 x 10^9\/L without transfusions (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Hemoglobin (Hgb) >= 9 g\/dL (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Serum creatinine =< 1.5 mg\/dL OR calculated creatinine clearance >= 50 mL\/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Negative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration\/randomization for women of childbearing potential only Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications Able and willing to provide informed written consent and able to comply with protocol requirement Able and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) NOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up Willing to provide blood and tissue samples for mandatory correlative research purposes Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up) CROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and\/or unresectable CROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory CROSSOVER INCLUSION CRITERIA: Measurable disease CROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1 CROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy CROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9\/L (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9\/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Hgb >= 9 g\/dL (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg\/dL OR calculated creatinine clearance >= 50 mL\/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only CROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications CROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements CROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) NOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up CROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes CROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)', 'Exclusion Criteria': \"Exclusion Criteria: Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed Prior treatment with trifluridine\/tipiracil (TAS-102) Pregnant or nursing (lactating women), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test Women of child-bearing potential NOTE: defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days prior to registration\/randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential Sexually active males NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period Any symptomatic brain metastasis NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks prior to registration\/randomization, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases at registration\/randomization Prior treatment =< 21 days prior to registration\/randomization with any other chemotherapy, small molecule inhibitor (e.g. regorafenib), monoclonal antibody, immunotherapy, or radiotherapy NOTE: All toxicities from prior therapy must be =< grade 1 (or =< grade 2 for peripheral neuropathy or alopecia) Impaired cardiovascular function or clinically significant cardiac diseases, including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to registration\/randomization Symptomatic chronic heart failure (i.e. grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\/or conduction abnormality < 6 months prior to registration\/randomization except atrial fibrillation and paroxysmal supraventricular tachycardia Left ventricular ejection fraction (LVEF) < 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram =< 28 days prior to registration\/randomization Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100mmHg despite current therapy History of thromboembolic or cerebrovascular events =< 12 weeks prior registration\/randomization. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or submassive) deep vein thrombosis or pulmonary emboli Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled Known history of acute or chronic pancreatitis =< 6 months prior to registration\/randomization Known positive serology for HIV (human immunodeficiency virus), active hepatitis B, and\/or active hepatitis C infection Patients who have neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) =< 12 months prior to registration\/randomization Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of binimetinib or palbociclib (e.g., ulcerative disease, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption) in the opinion of the investigator History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) Leptomeningeal disease Known hypersensitivity to the components of study drugs or its analogs Known medical, psychiatric, substance abuse, or cognitive disorder that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\/social situations that would limit compliance with study requirements in the opinion of the investigator Patients who have undergone major surgery =< 21 days prior to registration\/randomization or who have not recovered from side effects of such procedures Any other co-morbid, systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Previous or concurrent malignancy =< 3 years prior to registration\/randomization with the following exceptions: Adequately treated basal cell or squamous cell carcinoma of the skin Superficial bladder cancer Prostate intraepithelial neoplasm In situ carcinoma of the cervix Other solid tumors treated curatively without evidence of recurrence for >= 3 years prior to registration\/randomization NOTE: If there is a history or prior malignancy, must not be receiving other specific anti-cancer treatment such as anti-estrogen, anti-androgen, or other tyrosine kinase inhibitor therapy CROSSOVER EXCLUSION CRITERIA: Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed CROSSOVER EXCLUSION CRITERIA: Pregnant or nursing (lactating women), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test CROSSOVER EXCLUSION CRITERIA: Women of child-bearing potential NOTE: Defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days of re-registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential CROSSOVER EXCLUSION CRITERIA: Sexually active males NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period CROSSOVER EXCLUSION CRITERIA: Any symptomatic brain metastasis NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks, with imaging (e.g., MRI or CT) demonstrating no current evidence of progressive brain metastases at re-registration CROSSOVER EXCLUSION CRITERIA: Impaired cardiovascular function or clinically significant cardiac diseases, including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to re-registration Symptomatic chronic heart failure (i.e., grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\/or conduction abnormality < 6 months prior to re-registration except atrial fibrillation and paroxysmal supraventricular tachycardia Left ventricular ejection fraction (LVEF) < 50% as determined by a MUGA scan or echocardiogram CROSSOVER EXCLUSION CRITERIA: Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy CROSSOVER EXCLUSION CRITERIA: History of thromboembolic or cerebrovascular events =< 12 weeks prior re-registration. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks Note: Patients with thromboembolic events relat\"}","output":"{'Arm - Disease - Biomarker': 'KRAS\/NRAS Positive '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4\/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers ', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer. ', 'Condition': 'Metastatic Colorectal Carcinoma Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Unresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE: I. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib\/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC). SECONDARY OBJECTIVES: I. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib\/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC. II. To compare the overall survival (OS) between those randomized to palbociclib\/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC. III. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC. CORRELATIVE RESEARCH OBJECTIVES: I. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib\/binimetinib. II. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib\/binimetinib or TAS-102. III. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib\/binimetinib. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A. After completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria: Histological confirmation of colorectal cancer that is metastatic and\/or unresectable Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy Absolute neutrophil count (ANC) >= 1.5 x 10^9\/L (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Platelet count >= 75 x 10^9\/L without transfusions (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Hemoglobin (Hgb) >= 9 g\/dL (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Serum creatinine =< 1.5 mg\/dL OR calculated creatinine clearance >= 50 mL\/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration\/randomization unless otherwise noted) Negative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration\/randomization for women of childbearing potential only Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications Able and willing to provide informed written consent and able to comply with protocol requirement Able and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) NOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up Willing to provide blood and tissue samples for mandatory correlative research purposes Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up) CROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and\/or unresectable CROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory CROSSOVER INCLUSION CRITERIA: Measurable disease CROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1 CROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy CROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9\/L (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9\/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Hgb >= 9 g\/dL (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg\/dL OR calculated creatinine clearance >= 50 mL\/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted) CROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only CROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications CROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements CROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) NOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up CROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes CROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)', 'Exclusion Criteria': \"Exclusion Criteria: Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed Prior treatment with trifluridine\/tipiracil (TAS-102) Pregnant or nursing (lactating women), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test Women of child-bearing potential NOTE: defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days prior to registration\/randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential Sexually active males NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period Any symptomatic brain metastasis NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks prior to registration\/randomization, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases at registration\/randomization Prior treatment =< 21 days prior to registration\/randomization with any other chemotherapy, small molecule inhibitor (e.g. regorafenib), monoclonal antibody, immunotherapy, or radiotherapy NOTE: All toxicities from prior therapy must be =< grade 1 (or =< grade 2 for peripheral neuropathy or alopecia) Impaired cardiovascular function or clinically significant cardiac diseases, including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to registration\/randomization Symptomatic chronic heart failure (i.e. grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\/or conduction abnormality < 6 months prior to registration\/randomization except atrial fibrillation and paroxysmal supraventricular tachycardia Left ventricular ejection fraction (LVEF) < 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram =< 28 days prior to registration\/randomization Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100mmHg despite current therapy History of thromboembolic or cerebrovascular events =< 12 weeks prior registration\/randomization. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or submassive) deep vein thrombosis or pulmonary emboli Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled Known history of acute or chronic pancreatitis =< 6 months prior to registration\/randomization Known positive serology for HIV (human immunodeficiency virus), active hepatitis B, and\/or active hepatitis C infection Patients who have neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) =< 12 months prior to registration\/randomization Impaired gastrointestinal (GI) function or disease that may significantly alter the absorption of binimetinib or palbociclib (e.g., ulcerative disease, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption) in the opinion of the investigator History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) Leptomeningeal disease Known hypersensitivity to the components of study drugs or its analogs Known medical, psychiatric, substance abuse, or cognitive disorder that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\/social situations that would limit compliance with study requirements in the opinion of the investigator Patients who have undergone major surgery =< 21 days prior to registration\/randomization or who have not recovered from side effects of such procedures Any other co-morbid, systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Previous or concurrent malignancy =< 3 years prior to registration\/randomization with the following exceptions: Adequately treated basal cell or squamous cell carcinoma of the skin Superficial bladder cancer Prostate intraepithelial neoplasm In situ carcinoma of the cervix Other solid tumors treated curatively without evidence of recurrence for >= 3 years prior to registration\/randomization NOTE: If there is a history or prior malignancy, must not be receiving other specific anti-cancer treatment such as anti-estrogen, anti-androgen, or other tyrosine kinase inhibitor therapy CROSSOVER EXCLUSION CRITERIA: Prior treatment with drug targeting BRAF, MEK, ERK, or CDK family NOTE: For the purpose of this protocol, prior treatment with regorafenib is allowed CROSSOVER EXCLUSION CRITERIA: Pregnant or nursing (lactating women), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test CROSSOVER EXCLUSION CRITERIA: Women of child-bearing potential NOTE: Defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception throughout the study and for 8 weeks after study drug discontinuation NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation >= 42 days of re-registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential CROSSOVER EXCLUSION CRITERIA: Sexually active males NOTE: unless they agree to use highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation and should not father a child in this period CROSSOVER EXCLUSION CRITERIA: Any symptomatic brain metastasis NOTE: Patients previously treated or untreated for this condition who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for >= 4 weeks, with imaging (e.g., MRI or CT) demonstrating no current evidence of progressive brain metastases at re-registration CROSSOVER EXCLUSION CRITERIA: Impaired cardiovascular function or clinically significant cardiac diseases, including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to re-registration Symptomatic chronic heart failure (i.e., grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and\/or conduction abnormality < 6 months prior to re-registration except atrial fibrillation and paroxysmal supraventricular tachycardia Left ventricular ejection fraction (LVEF) < 50% as determined by a MUGA scan or echocardiogram CROSSOVER EXCLUSION CRITERIA: Uncontrolled hypertension, defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy CROSSOVER EXCLUSION CRITERIA: History of thromboembolic or cerebrovascular events =< 12 weeks prior re-registration. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks Note: Patients with thromboembolic events relat\"}","output":"{'Arm - Disease - Biomarker': 'KRAS\/NRAS Positive '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB\/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing No history of systemic anticancer therapy in metastatic\/non-curable settings Eastern Cooperative Oncology Group (ECOG) \u2264 1', 'Exclusion Criteria': 'Exclusion Criteria: Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved Symptomatic (treated or untreated) brain metastases Gastrointestinal (GI) tract disease causing the inability to take oral medication Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina Prior therapy with a KRAS G12C inhibitor'}","output":"{'Arm - Disease - Biomarker': 'KRAS p. G12C positive, PD-L1 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB\/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing No history of systemic anticancer therapy in metastatic\/non-curable settings Eastern Cooperative Oncology Group (ECOG) \u2264 1', 'Exclusion Criteria': 'Exclusion Criteria: Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved Symptomatic (treated or untreated) brain metastases Gastrointestinal (GI) tract disease causing the inability to take oral medication Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina Prior therapy with a KRAS G12C inhibitor'}","output":"{'Arm - Disease - Biomarker': 'KRAS p. G12C positive, PD-L1 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies', 'Brief Summary': 'This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.', 'Condition': 'Recurrent Lung Non-Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To evaluate the response rate (confirmed and unconfirmed) to trametinib plus docetaxel in the entire study population of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive non-small cell lung cancer (NSCLC) patients following one or two prior systemic therapies. SECONDARY OBJECTIVES: I. To evaluate if trametinib plus docetaxel is consistent with promise of activity measured by the response rate in G12C KRAS mutation positive NSCLC patients following one or two prior systemic therapies. II. To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients. III. To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population. IV. To evaluate the toxicity of the regimen. V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population. TRANSLATIONAL MEDICINE OBJECTIVES: I. To evaluate the response rates in the presence of comutations p53 and LKB1. II. To bank specimens for future research. OUTLINE: Patients receive trametinib orally (PO) on days 1-21. Patients also receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years. ', 'Inclusion Criteria': 'Inclusion Criteria: DISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable DISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)\/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) DISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 2 days prior to registration PRIOR\/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient\\'s lung cancer occurred more than 12 months after the last day of chemotherapy PRIOR\/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration PRIOR\/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required PRIOR\/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)\/v-akt murine thymoma viral oncogene homolog 1 (AKT)\/mammalian target of rapamycin (mTOR) pathway inhibitor PRIOR\/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration PRIOR\/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =< CTCAE grade 1 PRIOR\/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery PRIOR\/CONCURRENT THERAPY CRITERIA: Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John\\'s wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng) CLINICAL\/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2 CLINICAL\/LABORATORY CRITERIA: Absolute neutrophil count (ANC) >= 1500\/mcL; these results must be obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Platelet count >= 100,000\/mcL; these results must be obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Hemoglobin >= 9 grams\/dl; these results must be obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases); these results must be obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL\/min; this result must have been obtained within 28 days prior to registration CLINICAL\/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection CLINICAL\/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis CLINICAL\/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to New York Heart Association class II, congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study CLINICAL\/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett\\'s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation CLINICAL\/LABORATORY CRITERIA: Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) within 42 days prior to registration CLINICAL\/LABORATORY CRITERIA: Patients must not have untreated or unresolved retinopathy or have a history (or current evidence) of retinal vein occlusion determined by an ophthalmology exam within 42 days prior to registration CLINICAL\/LABORATORY CRITERIA: Patients must not have an immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO) or other agents used in the study CLINICAL\/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and\/or Hep B deoxyribonucleic acid [DNA] and\/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity CLINICAL\/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible CLINICAL\/LABORATORY CRITERIA: Patients must not be pregnant or nursing due to the risk of fetal or nursing infant harm; women\/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation and for 4 months after the last dose of the drug; a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\/she is responsible for beginning contraceptive measures SPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines REGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system', 'Exclusion Criteria': '-'}","output":"{'Arm - Disease - Biomarker': 'KRAS Mutation Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Phase IB\/II Study of Alpelisib in Combination With Paclitaxel in Patients With PIK3CA-altered Metastatic\/Recurrent Gastric Cancer', 'Brief Summary': 'Alpelisib (BYL719) is a PIK3CA-specific inhibitor, which was developed by Novartis (Basel, Switzerland). Our group conducted pre-clinical study of alpelisib in eight gastric cancer cell lines: four PIK3CA wild-type (SNU638, SNU668, SNU1, and SNU16) and four PIK3CA mutant (SNU719, AGS, SNU601, and MKN). As a result, alpelisib preferentially inhibited the growth of gastric cancer cells with PIK3CA mutations. In addition, alpelisib inhibited cell growth via G1 arrest and subsequently induces apoptosis in GC cells, and this effect is more remarkable in cells harboring PIK3CA mutations. Moreover, alpelisib in combination with paclitaxel showed synergistic cytotoxic effects and significantly increased apoptosis compared with alpelisib or paclitaxel monotherapy in GC cells. The purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase II dose (RP2D) of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided into Phase IB and Phase II.', 'Condition': 'Stomach Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Subject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed Age \u2265 20 years old of male and female At each phase of the trial, subjects who meet the following requirements in each phase will be enrolled. Phase IB: Subjects with a histologically-confirmed, advanced\/recurrent solid tumor who have progressed on standard therapy or whose disease does not have established standard therapy. Phase II: Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy (Tissue samples of gastric cancer must contain PIK3CA gene alterations (e.g. single nucleotide variants, small indels, amplifications, structural variations, etc.) identified by central or local next generation sequencing (NGS). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy. Phase IB: Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.) Phase II: Patient has at least one measurable lesion as per RECIST 1.1. ECOG performance status 0-1 Patient has adequate bone marrow and organ function as defined by the following laboratory values: Absolute neutrophil count (ANC) \u2265 1.5 x 109\/L Hemoglobin \u2265 9.0 g\/dL Platelet \u2265 100 x 109\/L Serum creatinine \u2264 ULN (upper limit of normal) or serum creatinine clearance \u226550 mL\/min (by Cockcroft-Gault formula, or 24h urine collection) Total bilirubin: \u2264 1.5 \u00d7 ULN Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage; Patients with Gilbert syndrome should also be included after confirming that the total bilirubin level is \u2264 1.5 x ULN in a follow-up screening test. Phase Ib: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \u2264 3 x ULN (regardless of liver metastases) Phase II: AST and ALT \u2264 3 x ULN if liver metastases are absent, or AST and ALT \u2264 5 x ULN if liver metastases are present. The subject is able to swallow and retain oral medication Serum \u03b2-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only). Requirement for contraception must be observed by the subject.', 'Exclusion Criteria': 'Exclusion Criteria: Patient has received previous treatment with a PI3K or AKT inhibitor. (Note: prior mTOR inhibitor treatment is allowed.) Patient has a known or suspicious hypersensitivity to paclitaxel or other products containing Cremophor. Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last does. Active central nervous system (CNS) lesions (i.e., those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without steroid therapy and the evidence of CNS disease progression for more than 4 weeks. However, patients with leptomeningeal metastases are excluded. Patient has not recovered to \u2264 grade 1 (except alopecia) from related adverse effects of any prior antineoplastic therapy Radiotherapy with a wide field (more than 30% of the bone marrow) of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment. Patient who has undergone major surgery \u2264 4 weeks prior to starting study treatment or who has not recovered from adverse effects of such procedure. Patient has a clinically significant cardiac disease or impaired cardiac function, such as: Acute coronary syndrome within the 6 months prior to the initiation of study drug (including myocardial infarction or unstable angina, Coronary Artery Bypass Graft surgery, percutaneous coronary intervention and stenting) Heart failure \u2265 grade 2 by New York Heart Association (NYHA) functional classification or that requires treatment Ejection fraction (EF) <50% on multi-gated acquisition (MUGA) scan or echocardiography examination. MUGA scan or echocardiography is not required as a screening test if there is no current suspicious symptom and past history of heart failure. Persistent uncontrolled hypertension as defined by: systolic >180 mmHg or diastolic >100 mmHg despite medical treatment Current or past history of clinically significant cardiac arrhythmia, atrial fibrillation, and\/or conduction abnormality including complete AV block, long QT syndrome, congenital long QT syndrome, or QTcF >470 msec at screening (if the average QTcF value > 470 msec by measuring 3 times consecutively in total). Any risk factors that prolong QTc or increase the probability of arrhythmia, including medication (e.g. heart failure, hypokalemia, congenital long QT syndrome, history of Torsades de Pointes) If the subject was diagnosed with diabetes (irrespective of treatment or symptom) or if the subject has \u2460 Korean Diabetes Prediction Score (Appendix A) more than 7 plus impaired glucose tolerance (with blood glucose of 140-199 mg\/dL after 2-hour oral glucose tolerance test (75g)), \u2461 previous history of gestational diabetes, or \u2462 steroid-induced diabetes. Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. untreated peptic ulcer disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or wide small bowel resection). Patient has a known positive serology for human immunodeficiency virus (HIV), active Hepatitis B, and\/or active Hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (e.g., entecavir, adefovir) Concomitant medication of strong or moderate inducers or inhibitors of CYP3A4 (Table 11) before the first dose of study treatment (In this case, if the drug is stopped for 1 week or more (according to Table 11) and changed to another drug that does not affect CYP3A4, then the subject can be enrolled.) History of other primary cancer. Exceptions are as follows: Adequately treated non-melanoma skin cancer (basal cell or squamous cell carcinoma), curatively treated in situ cancer of the cervix or stage I bladder cancer, completely resected thyroid cancer without distant metastasis in which all treatment has been completed (Appropriate wound healing is required prior to clinical trial enrollment) Other curatively treated solid tumors except for gastric cancer with no evidence of disease recurrence at least 24 months before participating in this trial History of allogeneic bone marrow transplantation or organ transplantation As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection\/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc.) Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial'}","output":"{'Arm - Disease - Biomarker': ' PIK3CA-altered mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-na\u00efve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age \u2265 18 years at the time of consent. Histologically or cytologically confirmed non-squamous, non-small cell lung cancer. Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy. Patients must have one of the following: NSCLC which harbours EGFR Exon 19 deletion. NSCLC which harbours EGFR L858R mutation. EGFR deletion\/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion\/mutation testing has not been done, it should be ordered per standard of care. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A). Measurable disease per RECIST 1.1. Patients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of \u2264 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent. Ability to take pills by mouth. Previous treatment with cytotoxic chemotherapy or immunotherapy is allowed. Patients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes: ANC >\/= 1,500\/mm3 platelet count >\/=100,000\/mm3 HgB \u2265 9 g\/dL (may be with transfusion) Creatinine \u2264 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) \u226540 mL\/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). The patient's urinary protein is \u2264 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is \u2265 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol). Total Serum Bilirubin \u2264 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin \u2264 3.0 x ULN, with direct bilirubin \u2264 1.5 x ULN) SGOT, SGPT \u2264 3 X ULN if no liver metastasis present SGOT, SGPT \u2264 5 X ULN if liver metastasis present The patient has adequate coagulation function as defined by International Normalized Ratio (INR) \u2264 1.5 and a partial thromboplastin time (PTT) (PTT\/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR \u2264 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices. Females of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details. Females of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol.\", 'Exclusion Criteria': 'Exclusion Criteria: Subjects unable to stop use of medications that are potent inducers of CYP3A4 or known to prolong QT interval. See Appendix B for additional details. Any prior history of other cancer within the prior 2 years with the exception of: adequately treated basal cell carcinoma, cervical intraepithelial neoplasia [CIN]\/cervical carcinoma in situ, melanoma in situ or ductal carcinoma in situ [DCIS], localized Gleason 6 prostate cancer, papillary thyroid cancer or other non-melanoma skin cancers. Previous treatment with any EGFR TKIs, including erlotinib, gefitinib, afatinib, avitinib, dacomitinib, rociletinib, or osimertinib. Previous treatment with any anti-VEGF medications, including vandetinib, nintedanib, bevacizumab, or ramucirumab. Spinal cord compression unless asymptomatic or stable for at least 2 weeks prior to start of study treatment. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator\\'s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. Patients with uncharacterized eye disorders. History of hypersensitivity of osimertinib or ramucirumab (or active or inactive excipients of osimertinib or ramucirumab). Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement. Any of the following cardiac criteria: Mean resting corrected QT interval (QTc using Fridericia\\'s formula) > 470 msec. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250msec. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy. The patient has uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy. The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") during the 3 months prior to first dose of protocol therapy. The patient has cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis. Any hemoptysis (defined as bright red blood or \u2265 1\/2 teaspoon) within 2 months prior to first dose of protocol therapy or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer. The patient has a prior history of GI perforation\/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy. The patient has undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery\/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial.'}","output":"{'Arm - Disease - Biomarker': 'Epidermal Growth Factor Receptor Mutant'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-na\u00efve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': \"Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age \u2265 18 years at the time of consent. Histologically or cytologically confirmed non-squamous, non-small cell lung cancer. Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy. Patients must have one of the following: NSCLC which harbours EGFR Exon 19 deletion. NSCLC which harbours EGFR L858R mutation. EGFR deletion\/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion\/mutation testing has not been done, it should be ordered per standard of care. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A). Measurable disease per RECIST 1.1. Patients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of \u2264 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent. Ability to take pills by mouth. Previous treatment with cytotoxic chemotherapy or immunotherapy is allowed. Patients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes: ANC >\/= 1,500\/mm3 platelet count >\/=100,000\/mm3 HgB \u2265 9 g\/dL (may be with transfusion) Creatinine \u2264 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) \u226540 mL\/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). The patient's urinary protein is \u2264 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is \u2265 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol). Total Serum Bilirubin \u2264 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin \u2264 3.0 x ULN, with direct bilirubin \u2264 1.5 x ULN) SGOT, SGPT \u2264 3 X ULN if no liver metastasis present SGOT, SGPT \u2264 5 X ULN if liver metastasis present The patient has adequate coagulation function as defined by International Normalized Ratio (INR) \u2264 1.5 and a partial thromboplastin time (PTT) (PTT\/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR \u2264 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices. Females of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details. Females of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol.\", 'Exclusion Criteria': 'Exclusion Criteria: Subjects unable to stop use of medications that are potent inducers of CYP3A4 or known to prolong QT interval. See Appendix B for additional details. Any prior history of other cancer within the prior 2 years with the exception of: adequately treated basal cell carcinoma, cervical intraepithelial neoplasia [CIN]\/cervical carcinoma in situ, melanoma in situ or ductal carcinoma in situ [DCIS], localized Gleason 6 prostate cancer, papillary thyroid cancer or other non-melanoma skin cancers. Previous treatment with any EGFR TKIs, including erlotinib, gefitinib, afatinib, avitinib, dacomitinib, rociletinib, or osimertinib. Previous treatment with any anti-VEGF medications, including vandetinib, nintedanib, bevacizumab, or ramucirumab. Spinal cord compression unless asymptomatic or stable for at least 2 weeks prior to start of study treatment. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator\\'s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. Patients with uncharacterized eye disorders. History of hypersensitivity of osimertinib or ramucirumab (or active or inactive excipients of osimertinib or ramucirumab). Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement. Any of the following cardiac criteria: Mean resting corrected QT interval (QTc using Fridericia\\'s formula) > 470 msec. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250msec. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy. The patient has uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy. The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") during the 3 months prior to first dose of protocol therapy. The patient has cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis. Any hemoptysis (defined as bright red blood or \u2265 1\/2 teaspoon) within 2 months prior to first dose of protocol therapy or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer. The patient has a prior history of GI perforation\/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy. The patient has undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery\/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial.'}","output":"{'Arm - Disease - Biomarker': 'Epidermal Growth Factor Receptor Mutant'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment na\u00efve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design. For Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34). The target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment na\u00efve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria: Histologically documented unresectable locally advanced\/metastatic non-squamous NSCLC Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 3: Treatment-na\u00efve for non curative treatment for locally advanced or metastatic NSCLC. Part 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy HER2overexpression status as determined by central review of tumor tissue WHO \/ ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function Part 3: Minimum body weight of 35 kg.', 'Exclusion Criteria': 'Exclusion criteria: HER2 mutation if previously known Has a history of (non-infectious) ILD\/pneumonitis that required steroids, has current ILD\/pneumonitis, or where suspected ILD\/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B (positive hepatitis B virus surface antigen or hepatitis B virus core antibody) or hepatitis C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class > II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia (Part 3). A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities not yet resolved to Grade \u2264 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. must not have any medical contraindication to platinum-based chemotherapy. Part 3 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.'}","output":"{'Arm - Disease - Biomarker': 'HER2 overexpression'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Randomized Phase IB\/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Na\u00efve Prostate Cancer That Retains RB Expression ', 'Brief Summary': 'This partially randomized phase IB\/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy na\u00efve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer. ', 'Condition': 'Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib) II. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II) SECONDARY OBJECTIVES: I. PSA progression-free survival. II. Radiographic progression-free survival. III. Safety. IV. Pharmacokinetics. TERTIARY OBJECTIVES: I. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue. II. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs. III. To explore resistance mechanisms of cyclin dependent kinase (CDK)4\/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib. IV. Explore the use\/correlation of circulating deoxyribonucleic acid (DNA)\/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib. V. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome. OUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study. PHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': \"Inclusion Criteria: Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures. Males 18 years of age and above Histological or cytological proof of prostate cancer Documented progressive mCRPC based on at least one of the following criteria: PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng\/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng\/mL. Soft-tissue progression defined as an increase \u2265 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan. 7) Have testosterone < 50 ng\/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required). 10) Patient has adequate bone marrow and organ function as defined by the following laboratory values: Absolute neutrophil count \u2265 1.5 \u00d7 109\/L. Platelets (UNVPLT) \u2265 100 \u00d7 109\/L. Hemoglobin (HGB) \u2265 9 g\/dl. Potassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication. INR \u2264 1.5. Serum creatinine (CREAT) \u2264 1.5 mg\/dL or creatine clearance > 50 mL\/min. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \u2264 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be \u2264 2.5 x ULN. Patients with liver metastases and AST\/ALT above this limit will not be enrolled.. Total serum bilirubin \u2264 1.5 x ULN; or total bilirubin (TBILI) \u2264 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome. 11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter. 12) Must be able to take oral medication without crushing, dissolving or chewing tablets.\", 'Exclusion Criteria': \"Exclusion Criteria: Prior exposure to abiraterone acetate or other specific CYP-17 inhibitors. Abiraterone acetate given in the castration-sensitive setting is permissible if stopped at least 6 months prior to initial protocol treatment. Prior exposure to enzalutamide or other investigational AR directed therapy Prior chemotherapy. Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of enrollment. Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of enrollment or unrecovered AEs due to agents administered more than 4 weeks of enrollment. History of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease. Known symptomatic brain metastases. Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethylstilbestrol (DES), ketoconazole, newer medications targeting ARs. NOTE: Because of the potential for drug-drug interaction, the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented. The principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system. Treatment-related toxicity from prior therapy > Grade 2. Peripheral neuropathy > 2 History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib including to peanut and soy or other drugs formulated with polysorbate 80; or enzalutamide. All herbal, alternative and food supplements (i.e., PC-Spes, Saw Palmetto, St John Wort, etc.). They must be discontinued prior to enrollment. Patients may continue on a daily Multi-Vitamin, calcium and Vitamin D. Planned surgery or radiation therapy during protocol treatment, Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including GnRH agonists or antagonists) are forbidden during the trial and must be stopped prior to enrollment. No washout period will be required for any of these agents. Initiation of bisphosphonate\/denosumab therapy during protocol treatment. Patients on stable doses of bisphosphonates or denosumab which have been started no less than 4 weeks prior to enrollment may continue on this medication. NOTE: Initiation of bisphosphonate\/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment. Patient has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Patient has a known history of HIV infection (testing not mandatory). Patient has any other concurrent severe and\/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Patient has clinically significant, uncontrolled heart disease and\/or recent events including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to enrollment History of documented congestive heart failure (New York Heart Association functional classification III-IV) Documented cardiomyopathy Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening History of any cardiac arrhythmias, eg., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months prior to enrollment. Family history of QTc prolongation or of unexplainable sudden death at <50 years of age. On screening 12 lead ECG, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec. Congenital long QT syndrome or family history of long QT syndrome. Systolic blood pressure (SBP) >160 mmHg or <90 mmHg. Bradycardia (heart rate < 50 at rest), by ECG or pulse, at screening On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs) Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to enrollment: Known strong inducers or inhibitors of CYP3A4\/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges. That have a narrow therapeutic window and are predominantly metabolized through CYP3A4\/5. That have a known risk to prolong the QT interval or induce Torsades de Pointes. Herbal preparations\/medications, dietary supplements Patient is currently receiving or has received systemic corticosteroids within <2 weeks prior to enrollment, or who have not fully recovered from side effects of such treatment. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. Patient who has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. Patient who has received radiotherapy \u2264 4 weeks or limited field radiation for palliation \u2264 2 weeks prior to enrollment, and who has not recovered to Grade 1 or better from related side effects of such therapy (exceptions include alopecia) and\/or in whom \u2265 30% of the bone marrow was irradiated. Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria: At least 4 weeks from prior therapy completion (including radiation and\/or surgery) to enrollment Clinically stable CNS tumor at the time of screening and not receiving steroids and\/or enzyme-inducing anti-epileptic medications for brain metastases Patient has had major surgery within 14 days prior to enrollment or has not recovered from major side effects (tumor biopsy is not considered as major surgery). Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 4.03 Grade <1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study). Patient with a Child-Pugh score B or C. Patient has a history of non-compliance to medical regimen or inability to grant consent. Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid.\"}","output":"{'Arm - Disease - Biomarker': 'RB Expression Retainng '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Randomized Phase IB\/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Na\u00efve Prostate Cancer That Retains RB Expression ', 'Brief Summary': 'This partially randomized phase IB\/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy na\u00efve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer. ', 'Condition': 'Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib) II. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II) SECONDARY OBJECTIVES: I. PSA progression-free survival. II. Radiographic progression-free survival. III. Safety. IV. Pharmacokinetics. TERTIARY OBJECTIVES: I. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue. II. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs. III. To explore resistance mechanisms of cyclin dependent kinase (CDK)4\/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib. IV. Explore the use\/correlation of circulating deoxyribonucleic acid (DNA)\/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib. V. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome. OUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study. PHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': \"Inclusion Criteria: Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures. Males 18 years of age and above Histological or cytological proof of prostate cancer Documented progressive mCRPC based on at least one of the following criteria: PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng\/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng\/mL. Soft-tissue progression defined as an increase \u2265 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan. 7) Have testosterone < 50 ng\/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required). 10) Patient has adequate bone marrow and organ function as defined by the following laboratory values: Absolute neutrophil count \u2265 1.5 \u00d7 109\/L. Platelets (UNVPLT) \u2265 100 \u00d7 109\/L. Hemoglobin (HGB) \u2265 9 g\/dl. Potassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication. INR \u2264 1.5. Serum creatinine (CREAT) \u2264 1.5 mg\/dL or creatine clearance > 50 mL\/min. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \u2264 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be \u2264 2.5 x ULN. Patients with liver metastases and AST\/ALT above this limit will not be enrolled.. Total serum bilirubin \u2264 1.5 x ULN; or total bilirubin (TBILI) \u2264 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome. 11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter. 12) Must be able to take oral medication without crushing, dissolving or chewing tablets.\", 'Exclusion Criteria': \"Exclusion Criteria: Prior exposure to abiraterone acetate or other specific CYP-17 inhibitors. Abiraterone acetate given in the castration-sensitive setting is permissible if stopped at least 6 months prior to initial protocol treatment. Prior exposure to enzalutamide or other investigational AR directed therapy Prior chemotherapy. Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of enrollment. Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of enrollment or unrecovered AEs due to agents administered more than 4 weeks of enrollment. History of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease. Known symptomatic brain metastases. Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethylstilbestrol (DES), ketoconazole, newer medications targeting ARs. NOTE: Because of the potential for drug-drug interaction, the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented. The principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system. Treatment-related toxicity from prior therapy > Grade 2. Peripheral neuropathy > 2 History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib including to peanut and soy or other drugs formulated with polysorbate 80; or enzalutamide. All herbal, alternative and food supplements (i.e., PC-Spes, Saw Palmetto, St John Wort, etc.). They must be discontinued prior to enrollment. Patients may continue on a daily Multi-Vitamin, calcium and Vitamin D. Planned surgery or radiation therapy during protocol treatment, Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including GnRH agonists or antagonists) are forbidden during the trial and must be stopped prior to enrollment. No washout period will be required for any of these agents. Initiation of bisphosphonate\/denosumab therapy during protocol treatment. Patients on stable doses of bisphosphonates or denosumab which have been started no less than 4 weeks prior to enrollment may continue on this medication. NOTE: Initiation of bisphosphonate\/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment. Patient has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Patient has a known history of HIV infection (testing not mandatory). Patient has any other concurrent severe and\/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Patient has clinically significant, uncontrolled heart disease and\/or recent events including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to enrollment History of documented congestive heart failure (New York Heart Association functional classification III-IV) Documented cardiomyopathy Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening History of any cardiac arrhythmias, eg., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months prior to enrollment. Family history of QTc prolongation or of unexplainable sudden death at <50 years of age. On screening 12 lead ECG, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec. Congenital long QT syndrome or family history of long QT syndrome. Systolic blood pressure (SBP) >160 mmHg or <90 mmHg. Bradycardia (heart rate < 50 at rest), by ECG or pulse, at screening On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs) Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to enrollment: Known strong inducers or inhibitors of CYP3A4\/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges. That have a narrow therapeutic window and are predominantly metabolized through CYP3A4\/5. That have a known risk to prolong the QT interval or induce Torsades de Pointes. Herbal preparations\/medications, dietary supplements Patient is currently receiving or has received systemic corticosteroids within <2 weeks prior to enrollment, or who have not fully recovered from side effects of such treatment. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. Patient who has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. Patient who has received radiotherapy \u2264 4 weeks or limited field radiation for palliation \u2264 2 weeks prior to enrollment, and who has not recovered to Grade 1 or better from related side effects of such therapy (exceptions include alopecia) and\/or in whom \u2265 30% of the bone marrow was irradiated. Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria: At least 4 weeks from prior therapy completion (including radiation and\/or surgery) to enrollment Clinically stable CNS tumor at the time of screening and not receiving steroids and\/or enzyme-inducing anti-epileptic medications for brain metastases Patient has had major surgery within 14 days prior to enrollment or has not recovered from major side effects (tumor biopsy is not considered as major surgery). Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 4.03 Grade <1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study). Patient with a Child-Pugh score B or C. Patient has a history of non-compliance to medical regimen or inability to grant consent. Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid.\"}","output":"{'Arm - Disease - Biomarker': 'RB Expression Retainng '}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Modified FOLFOX Plus\/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety\/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm. Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg\/m\u00b2 iv over two hours (day 1), Leucovorin at a dose of 400 mg\/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg\/m\u00b2 iv bolus (day 1), and Fluorouracil at a dose of 2400 mg\/m\u00b2 iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg \"Flatdose\" i.v. d1 every 2 weeks) and Ipilimumab (1mg\/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg \"Flatdose\" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg\/\u00b2, Oxaliplatin 85 mg\/m\u00b2, leucovorin 200 mg\/m\u00b2 on day 1 and fluorouracil 2600 mg\/m\u00b2 IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks). Treatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment. The primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1). Secondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis. 257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria: All subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma. Subjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour. Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and\/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization\/enrolment. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization\/enrolment. Subjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D). ECOG performance status score of 0 or 1 (Appendix B). Life expectancy > 12 weeks Screening laboratory values must meet the following criteria (using NCI CTCAE v.4.03): WBC \u2265 2000\/uL Neutrophils \u2265 1500\/\u00b5L Platelets \u2265 100x10^3\/\u00b5L Hemoglobin \u2265 9.0 g\/dL Serum creatinine \u2264 1.5 x ULN AST \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) ALT \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) Total Bilirubin \u2264 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN) Males and Females* \u2265 18 years of age *There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently. Subjects must have signed and dated an IRB\/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding. WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.', 'Exclusion Criteria': 'Exclusion Criteria: Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Subjects with untreated symptomatic CNS metastases. Subjects are eligible if CNS metastases are asymptomatic (this includes patients with unknown CNS metastatic status who have no clinical signs of CNS metastases) or those with asymptomatic or symptomatic CNS who are adequately treated and are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization\/enrolment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization\/enrolment. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and\/or MRI scans, or CNS metastases are confirmed but adequately treated as described above. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. > Grade 1 peripheral neuropathy according to CTCAE version 4.0 Known Dihydropyrimidine dehydrogenase (DPD) deficiency Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. Ascites which cannot be controlled with appropriate interventions. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4 Significant acute or chronic infections including, among others: Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. History of allergy or hypersensitivity to study drugs or any constituent of the products Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \u00a7 40 Abs. 1 S. 3 Nr. 4 AMG. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [\u00a7 40 Abs. 1 S. 3 Nr. 3a AMG].'}","output":"{'Arm - Disease - Biomarker': 'HER2-negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Modified FOLFOX Plus\/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety\/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm. Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg\/m\u00b2 iv over two hours (day 1), Leucovorin at a dose of 400 mg\/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg\/m\u00b2 iv bolus (day 1), and Fluorouracil at a dose of 2400 mg\/m\u00b2 iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg \"Flatdose\" i.v. d1 every 2 weeks) and Ipilimumab (1mg\/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg \"Flatdose\" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg\/\u00b2, Oxaliplatin 85 mg\/m\u00b2, leucovorin 200 mg\/m\u00b2 on day 1 and fluorouracil 2600 mg\/m\u00b2 IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks). Treatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment. The primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1). Secondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis. 257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria: All subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma. Subjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour. Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and\/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization\/enrolment. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization\/enrolment. Subjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D). ECOG performance status score of 0 or 1 (Appendix B). Life expectancy > 12 weeks Screening laboratory values must meet the following criteria (using NCI CTCAE v.4.03): WBC \u2265 2000\/uL Neutrophils \u2265 1500\/\u00b5L Platelets \u2265 100x10^3\/\u00b5L Hemoglobin \u2265 9.0 g\/dL Serum creatinine \u2264 1.5 x ULN AST \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) ALT \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) Total Bilirubin \u2264 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN) Males and Females* \u2265 18 years of age *There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently. Subjects must have signed and dated an IRB\/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding. WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.', 'Exclusion Criteria': 'Exclusion Criteria: Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Subjects with untreated symptomatic CNS metastases. Subjects are eligible if CNS metastases are asymptomatic (this includes patients with unknown CNS metastatic status who have no clinical signs of CNS metastases) or those with asymptomatic or symptomatic CNS who are adequately treated and are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization\/enrolment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization\/enrolment. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and\/or MRI scans, or CNS metastases are confirmed but adequately treated as described above. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. > Grade 1 peripheral neuropathy according to CTCAE version 4.0 Known Dihydropyrimidine dehydrogenase (DPD) deficiency Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. Ascites which cannot be controlled with appropriate interventions. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4 Significant acute or chronic infections including, among others: Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. History of allergy or hypersensitivity to study drugs or any constituent of the products Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \u00a7 40 Abs. 1 S. 3 Nr. 4 AMG. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [\u00a7 40 Abs. 1 S. 3 Nr. 3a AMG].'}","output":"{'Arm - Disease - Biomarker': 'HER2-negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Modified FOLFOX Plus\/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety\/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm. Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg\/m\u00b2 iv over two hours (day 1), Leucovorin at a dose of 400 mg\/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg\/m\u00b2 iv bolus (day 1), and Fluorouracil at a dose of 2400 mg\/m\u00b2 iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg \"Flatdose\" i.v. d1 every 2 weeks) and Ipilimumab (1mg\/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg \"Flatdose\" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg\/\u00b2, Oxaliplatin 85 mg\/m\u00b2, leucovorin 200 mg\/m\u00b2 on day 1 and fluorouracil 2600 mg\/m\u00b2 IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks). Treatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment. The primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1). Secondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis. 257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria: All subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma. Subjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour. Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and\/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization\/enrolment. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization\/enrolment. Subjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D). ECOG performance status score of 0 or 1 (Appendix B). Life expectancy > 12 weeks Screening laboratory values must meet the following criteria (using NCI CTCAE v.4.03): WBC \u2265 2000\/uL Neutrophils \u2265 1500\/\u00b5L Platelets \u2265 100x10^3\/\u00b5L Hemoglobin \u2265 9.0 g\/dL Serum creatinine \u2264 1.5 x ULN AST \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) ALT \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) Total Bilirubin \u2264 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN) Males and Females* \u2265 18 years of age *There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently. Subjects must have signed and dated an IRB\/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding. WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.', 'Exclusion Criteria': 'Exclusion Criteria: Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Subjects with untreated symptomatic CNS metastases. Subjects are eligible if CNS metastases are asymptomatic (this includes patients with unknown CNS metastatic status who have no clinical signs of CNS metastases) or those with asymptomatic or symptomatic CNS who are adequately treated and are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization\/enrolment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization\/enrolment. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and\/or MRI scans, or CNS metastases are confirmed but adequately treated as described above. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. > Grade 1 peripheral neuropathy according to CTCAE version 4.0 Known Dihydropyrimidine dehydrogenase (DPD) deficiency Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. Ascites which cannot be controlled with appropriate interventions. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4 Significant acute or chronic infections including, among others: Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. History of allergy or hypersensitivity to study drugs or any constituent of the products Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \u00a7 40 Abs. 1 S. 3 Nr. 4 AMG. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [\u00a7 40 Abs. 1 S. 3 Nr. 3a AMG].'}","output":"{'Arm - Disease - Biomarker': 'HER2-negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'Modified FOLFOX Plus\/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety\/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm. Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg\/m\u00b2 iv over two hours (day 1), Leucovorin at a dose of 400 mg\/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg\/m\u00b2 iv bolus (day 1), and Fluorouracil at a dose of 2400 mg\/m\u00b2 iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg \"Flatdose\" i.v. d1 every 2 weeks) and Ipilimumab (1mg\/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks and Ipilimumab at 1mg\/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg \"Flatdose\" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg\/\u00b2, Oxaliplatin 85 mg\/m\u00b2, leucovorin 200 mg\/m\u00b2 on day 1 and fluorouracil 2600 mg\/m\u00b2 IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg \"Flatdose\" i.v. d1 every 2 weeks). Treatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment. The primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1). Secondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis. 257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria: All subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma. Subjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour. Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and\/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization\/enrolment. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization\/enrolment. Subjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D). ECOG performance status score of 0 or 1 (Appendix B). Life expectancy > 12 weeks Screening laboratory values must meet the following criteria (using NCI CTCAE v.4.03): WBC \u2265 2000\/uL Neutrophils \u2265 1500\/\u00b5L Platelets \u2265 100x10^3\/\u00b5L Hemoglobin \u2265 9.0 g\/dL Serum creatinine \u2264 1.5 x ULN AST \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) ALT \u2264 3.0 x ULN (or \u2264 5.0X ULN if liver metastates are present) Total Bilirubin \u2264 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN) Males and Females* \u2265 18 years of age *There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently. Subjects must have signed and dated an IRB\/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding. WOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.', 'Exclusion Criteria': 'Exclusion Criteria: Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Subjects with untreated symptomatic CNS metastases. Subjects are eligible if CNS metastases are asymptomatic (this includes patients with unknown CNS metastatic status who have no clinical signs of CNS metastases) or those with asymptomatic or symptomatic CNS who are adequately treated and are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization\/enrolment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization\/enrolment. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and\/or MRI scans, or CNS metastases are confirmed but adequately treated as described above. Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consent. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. > Grade 1 peripheral neuropathy according to CTCAE version 4.0 Known Dihydropyrimidine dehydrogenase (DPD) deficiency Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. Ascites which cannot be controlled with appropriate interventions. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4 Significant acute or chronic infections including, among others: Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. History of allergy or hypersensitivity to study drugs or any constituent of the products Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \u00a7 40 Abs. 1 S. 3 Nr. 4 AMG. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [\u00a7 40 Abs. 1 S. 3 Nr. 3a AMG].'}","output":"{'Arm - Disease - Biomarker': 'HER2-negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage \u2162B-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: \u2265 18 and \u2264 70 years of age Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 1. Life expectancy of more than 3 weeks. Histologically or cytologic confirmed\uff0clocally advanced and\/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy. Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) . None previous chemotherapy or targeted therapy. NOTE: neoadjuvant and\/or adjuvant therapy is allowed which is completed before 6 months. Prior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation. Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) \u2265 1.5\u00d7109\/L, Platelet (PLT) \u2265 100\u00d7109\/L, Hemoglobin(HB) \u2265 100 g\/L, total bilirubin within 1.5\u00d7the upper limit of normal(ULN), and serum transaminase\u22642.5\u00d7the Upper Limit Of Normal(ULN), serum creatine \u2264 1 x Upper Limit Of Normal(ULN), creatinine clearance rate \u2265 50ml\/min, For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.', 'Exclusion Criteria': \"Exclusion Criteria: Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer) Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\\\\CT or venography that no hematencephalon symptom); Radiologically documented evidence of major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor. Uncontrolled hypertension(systolic pressure \u2265 140 mmHg and\/or diastolic pressure \u2265 90 mm Hg) even though two or more than two hypotensive agents application. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male \u2265 450 ms, female \u2265 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; History of pulmonary interstitial diseases or concurrent pulmonary interstitial diseases. Coagulation disfunction\uff08INR>1.5 o rPT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)\uff09, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation. History of clinically significant haemoptysis =< 2 months (more than 2.5ml or half of one tea spoon of fresh blood per day) prior to registration. History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding gastric ulcer, occult blood test \u2265 (++), and vasculitis ; Within 6 months before the first treatment occurs artery \/ venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack(TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Known inherited and acquired hemorrhagic and thromboplastic possibility (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.) Long-term untreated wounds or fractures. Within 4 weeks of major surgery and\/or injures, fractures , ulceration. Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction); History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess \u2264 6 months. Urine protein\u2265++, or 24h urine protein quantitation\u22651.0g; Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium); Active infection need antimicrobial treatments; History of psychiatric drugs abuse and not be abstinent, or dysphrenia; Less than 4 weeks from the last clinical trial History or concomitant other malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer; Administration of strong\/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days; Pregnant or breastfeeding women; Other conditions regimented at investigators' discretion. \"}","output":"{'Arm - Disease - Biomarker': 'EGFR Mutation-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage \u2162B-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: \u2265 18 and \u2264 70 years of age Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 1. Life expectancy of more than 3 weeks. Histologically or cytologic confirmed\uff0clocally advanced and\/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy. Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) . None previous chemotherapy or targeted therapy. NOTE: neoadjuvant and\/or adjuvant therapy is allowed which is completed before 6 months. Prior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation. Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) \u2265 1.5\u00d7109\/L, Platelet (PLT) \u2265 100\u00d7109\/L, Hemoglobin(HB) \u2265 100 g\/L, total bilirubin within 1.5\u00d7the upper limit of normal(ULN), and serum transaminase\u22642.5\u00d7the Upper Limit Of Normal(ULN), serum creatine \u2264 1 x Upper Limit Of Normal(ULN), creatinine clearance rate \u2265 50ml\/min, For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.', 'Exclusion Criteria': \"Exclusion Criteria: Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer) Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\\\\CT or venography that no hematencephalon symptom); Radiologically documented evidence of major blood vessel invasion or encasement by cancer; Obvious cavity or necrosis formed in the tumor. Uncontrolled hypertension(systolic pressure \u2265 140 mmHg and\/or diastolic pressure \u2265 90 mm Hg) even though two or more than two hypotensive agents application. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male \u2265 450 ms, female \u2265 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; History of pulmonary interstitial diseases or concurrent pulmonary interstitial diseases. Coagulation disfunction\uff08INR>1.5 o rPT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)\uff09, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation. History of clinically significant haemoptysis =< 2 months (more than 2.5ml or half of one tea spoon of fresh blood per day) prior to registration. History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding gastric ulcer, occult blood test \u2265 (++), and vasculitis ; Within 6 months before the first treatment occurs artery \/ venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack(TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Known inherited and acquired hemorrhagic and thromboplastic possibility (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.) Long-term untreated wounds or fractures. Within 4 weeks of major surgery and\/or injures, fractures , ulceration. Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction); History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess \u2264 6 months. Urine protein\u2265++, or 24h urine protein quantitation\u22651.0g; Symptomatic serous effusion requiring treatment .(including hydrothorax, ascites, hydropericardium); Active infection need antimicrobial treatments; History of psychiatric drugs abuse and not be abstinent, or dysphrenia; Less than 4 weeks from the last clinical trial History or concomitant other malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer; Administration of strong\/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days; Pregnant or breastfeeding women; Other conditions regimented at investigators' discretion. \"}","output":"{'Arm - Disease - Biomarker': 'EGFR Mutation-Positive'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS) ', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC. ', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study. All eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met. Patients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Informed consent Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses. Age Participant must be \u226518 years at the time of signing the ICF. All genders are permitted. Type of Participant and Disease Characteristics Histologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity. Has not received any systemic treatment of advanced NSCLC. Prior adjuvant\/neo-adjuvant therapy completed > 6 months before screening is allowed. MET amplification\/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line. MET high expression by IHC, 3+ in \u226575% of tumor cells increased MET gene copy number by FISH, MET gene copy \u22655 or MET \/ CEP7 ratio \u22652; or by tissue NGS, \u226520% tumour cells, \u2265200x sequencing depth of coverage and CN \u22655. Local IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available. WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks. At least 1 lesion that can be accurately measured at baseline as \u226510 mm in the longest diameter (except lymph nodes, which must have short axis \u226515 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. Adequate haematological function defined as: Haemoglobin\u22658.5 g\/dL (no transfusion in the past 2 weeks). Absolute neutrophil count \u22651.5\u00d7109\/L. Platelet count \u2265100,000\/\u03bcL (no transfusion in the past 10 days) Adequate liver function defined as: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \u22642.5 x the upper limit of normal (ULN) with total bilirubin (TBL) \u2264 ULN OR TBL >ULN to \u22641.5x ULN with ALT and AST \u2264 ULN Adequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate \u226550 mL\/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN. Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters. Patients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for \u22652 weeks. Ability to swallow and retain oral medications. Willingness and ability to comply with study and follow-up procedures. Reproduction Females must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution. Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. Further information is available in Appendix F (Contraception Requirements). Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions As judged by the investigator, active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade \u22652, malabsorption syndrome or previous significant bowel resection). Any of the following cardiac diseases currently or within the last 6 months: Unstable angina pectoris Congestive heart failure (New York Heart Association [NYHA] \u2265Grade 2) Acute myocardial infarction Stroke or transient ischemic attack Uncontrolled hypertension (BP \u2265150\/95 mmHg despite medical therapy). Mean resting correct QT interval (QTcF) >470 msec for women and >450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value. Any factors that may increase the risk of QTcF prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\/plasma potassium < LLN; Serum\/plasma magnesium < LLN; Serum\/plasma calcium < LLN), congenital or familial long QT syndrome, family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECGs, eg, complete left bundle branch block, third degree heart block, second degree heart block, P-R interval >250 msec. Acute coronary syndrome Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered \u226428 days or limited field radiation for palliation \u22647 days prior to starting study drug or has not recovered from side effects of such therapy. Major surgical procedures \u226428 days of beginning study drug or minor surgical procedures \u22647 days. No waiting is required following port-a-cath placement. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol. Active hepatitis B (HBV) (positive HBV surface antigen [HBsAg] result) or hepatitis C (HCV). Viral testing is not required for assessment of eligibility for the study. Patients with a past or resolved HBV or HCV infection are eligible if: Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc] or Positive for HBsAg, but for >6 months have had normal transaminases and HBV DNA levels between 0 to 2000 IU\/mL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study. HBV DNA levels >2000 IU\/mL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study. Patients with positive HCV antibody are eligible only if the polymerase chain reaction is negative for HCV ribonucleic acid. Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, non-invasive) are eligible, as are patients with history of non-melanoma skin cancer. Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment\/randomization with the exception of alopecia Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study intervention. Subjects with leptomeningeal metastases are ineligible. Past medical history of ILD\/pneumonitis, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive human immunodeficiency virus 1\/2 antibodies). Testing is not required for assessment of eligibility for the study.. Known history of liver fibrosis\/cirrhosis. Known contraindications to osimertinib administration. Known hypersensitivity to the active or inactive excipients of osimertinib or savolitinib or drugs with a similar chemical structure or class. Prior\/Concomitant Therapy Prior exposure to HGF\/MET inhibitors, e.g., foretinib, crizotinib, cabozantinib, merestinib, onartuzumab, capmatinib, tepotinib, etc.. Prior exposure to EGFR TKI. Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4, strong inhibitors of CYP1A2, within 2 weeks of the first dose of study treatment (3 weeks for St John's Wort) will be excluded. All patients must try to avoid concomitant use of any medications, herbal supplements and\/or ingestion of foods with known inducer effects on CYP3A4 during the study and for 3 months later the last dose intake. Prior\/Concurrent Clinical Study Experience Participation in another clinical study with a study interventional medication administered within five half-lives of the compound or 3 months, whichever is greater or investigational medicinal device administered in the last 30 days prior to randomisation\/first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Other Exclusions Involvement in the planning and\/or conduct of the study (applies to both AstraZeneca staff and\/or staff at the study site). Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements. For women only-Currently breastfeeding. Previous enrolment in the present study. Without civil capacity or with restricted civil capacity. Any other reasons judged by the leading investigator to prevent the subject from participating in this study\"}","output":"{'Arm - Disease - Biomarker': 'MET Positive, EGFRm+'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS) ', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC. ', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study. All eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met. Patients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Informed consent Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses. Age Participant must be \u226518 years at the time of signing the ICF. All genders are permitted. Type of Participant and Disease Characteristics Histologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity. Has not received any systemic treatment of advanced NSCLC. Prior adjuvant\/neo-adjuvant therapy completed > 6 months before screening is allowed. MET amplification\/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line. MET high expression by IHC, 3+ in \u226575% of tumor cells increased MET gene copy number by FISH, MET gene copy \u22655 or MET \/ CEP7 ratio \u22652; or by tissue NGS, \u226520% tumour cells, \u2265200x sequencing depth of coverage and CN \u22655. Local IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available. WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks. At least 1 lesion that can be accurately measured at baseline as \u226510 mm in the longest diameter (except lymph nodes, which must have short axis \u226515 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. Adequate haematological function defined as: Haemoglobin\u22658.5 g\/dL (no transfusion in the past 2 weeks). Absolute neutrophil count \u22651.5\u00d7109\/L. Platelet count \u2265100,000\/\u03bcL (no transfusion in the past 10 days) Adequate liver function defined as: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \u22642.5 x the upper limit of normal (ULN) with total bilirubin (TBL) \u2264 ULN OR TBL >ULN to \u22641.5x ULN with ALT and AST \u2264 ULN Adequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate \u226550 mL\/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN. Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters. Patients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for \u22652 weeks. Ability to swallow and retain oral medications. Willingness and ability to comply with study and follow-up procedures. Reproduction Females must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution. Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. Further information is available in Appendix F (Contraception Requirements). Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions As judged by the investigator, active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade \u22652, malabsorption syndrome or previous significant bowel resection). Any of the following cardiac diseases currently or within the last 6 months: Unstable angina pectoris Congestive heart failure (New York Heart Association [NYHA] \u2265Grade 2) Acute myocardial infarction Stroke or transient ischemic attack Uncontrolled hypertension (BP \u2265150\/95 mmHg despite medical therapy). Mean resting correct QT interval (QTcF) >470 msec for women and >450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value. Any factors that may increase the risk of QTcF prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\/plasma potassium < LLN; Serum\/plasma magnesium < LLN; Serum\/plasma calcium < LLN), congenital or familial long QT syndrome, family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECGs, eg, complete left bundle branch block, third degree heart block, second degree heart block, P-R interval >250 msec. Acute coronary syndrome Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered \u226428 days or limited field radiation for palliation \u22647 days prior to starting study drug or has not recovered from side effects of such therapy. Major surgical procedures \u226428 days of beginning study drug or minor surgical procedures \u22647 days. No waiting is required following port-a-cath placement. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol. Active hepatitis B (HBV) (positive HBV surface antigen [HBsAg] result) or hepatitis C (HCV). Viral testing is not required for assessment of eligibility for the study. Patients with a past or resolved HBV or HCV infection are eligible if: Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc] or Positive for HBsAg, but for >6 months have had normal transaminases and HBV DNA levels between 0 to 2000 IU\/mL (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study. HBV DNA levels >2000 IU\/mL but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study. Patients with positive HCV antibody are eligible only if the polymerase chain reaction is negative for HCV ribonucleic acid. Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, non-invasive) are eligible, as are patients with history of non-melanoma skin cancer. Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment\/randomization with the exception of alopecia Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study intervention. Subjects with leptomeningeal metastases are ineligible. Past medical history of ILD\/pneumonitis, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive human immunodeficiency virus 1\/2 antibodies). Testing is not required for assessment of eligibility for the study.. Known history of liver fibrosis\/cirrhosis. Known contraindications to osimertinib administration. Known hypersensitivity to the active or inactive excipients of osimertinib or savolitinib or drugs with a similar chemical structure or class. Prior\/Concomitant Therapy Prior exposure to HGF\/MET inhibitors, e.g., foretinib, crizotinib, cabozantinib, merestinib, onartuzumab, capmatinib, tepotinib, etc.. Prior exposure to EGFR TKI. Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4, strong inhibitors of CYP1A2, within 2 weeks of the first dose of study treatment (3 weeks for St John's Wort) will be excluded. All patients must try to avoid concomitant use of any medications, herbal supplements and\/or ingestion of foods with known inducer effects on CYP3A4 during the study and for 3 months later the last dose intake. Prior\/Concurrent Clinical Study Experience Participation in another clinical study with a study interventional medication administered within five half-lives of the compound or 3 months, whichever is greater or investigational medicinal device administered in the last 30 days prior to randomisation\/first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Other Exclusions Involvement in the planning and\/or conduct of the study (applies to both AstraZeneca staff and\/or staff at the study site). Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements. For women only-Currently breastfeeding. Previous enrolment in the present study. Without civil capacity or with restricted civil capacity. Any other reasons judged by the leading investigator to prevent the subject from participating in this study\"}","output":"{'Arm - Disease - Biomarker': 'MET Positive, EGFRm+'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status Has human epidermal growth factor receptor 2 (HER2) negative cancer Male Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period Female Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze\/store for her own use for the purpose of reproduction during this period Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment', 'Exclusion Criteria': \"Exclusion Criteria: Has squamous cell or undifferentiated gastric cancer Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and\/or complications from previous surgery Has preexisting peripheral neuropathy >Grade 1 Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation Has had previous therapy for locally advanced, unresectable or metastatic gastric\/GEJ cancer. Participants may have received prior neoadjuvant and\/or adjuvant therapy as long as it was completed \u22656 months prior to randomization Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti- PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137) Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all AEs due to any previous therapies to \u2264Grade 1 or baseline Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\u22642 weeks of radiotherapy) to non central nervous system (CNS) disease Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy Has known active CNS metastases and\/or carcinomatous meningitis Has severe hypersensitivity (\u2265Grade 3) to pembrolizumab and\/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection Has a known history of active tuberculosis Has hypokalemia (serum potassium less than the lower limit of normal) Has hypomagnesemia (serum magnesium less than the lower limit of normal) Has hypocalcemia (serum calcium less than the lower limit of normal) Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last Has had an allogenic tissue\/solid organ transplant Has a known severe hypersensitivity (\u2265 Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and\/or to any of their excipients For participants taking cisplatin: has Grade \u22652 audiometric hearing loss\"}","output":"{'Arm - Disease - Biomarker': 'HER2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status Has human epidermal growth factor receptor 2 (HER2) negative cancer Male Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period Female Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze\/store for her own use for the purpose of reproduction during this period Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment', 'Exclusion Criteria': \"Exclusion Criteria: Has squamous cell or undifferentiated gastric cancer Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and\/or complications from previous surgery Has preexisting peripheral neuropathy >Grade 1 Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation Has had previous therapy for locally advanced, unresectable or metastatic gastric\/GEJ cancer. Participants may have received prior neoadjuvant and\/or adjuvant therapy as long as it was completed \u22656 months prior to randomization Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti- PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137) Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all AEs due to any previous therapies to \u2264Grade 1 or baseline Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\u22642 weeks of radiotherapy) to non central nervous system (CNS) disease Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy Has known active CNS metastases and\/or carcinomatous meningitis Has severe hypersensitivity (\u2265Grade 3) to pembrolizumab and\/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection Has a known history of active tuberculosis Has hypokalemia (serum potassium less than the lower limit of normal) Has hypomagnesemia (serum magnesium less than the lower limit of normal) Has hypocalcemia (serum calcium less than the lower limit of normal) Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last Has had an allogenic tissue\/solid organ transplant Has a known severe hypersensitivity (\u2265 Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and\/or to any of their excipients For participants taking cisplatin: has Grade \u22652 audiometric hearing loss\"}","output":"{'Arm - Disease - Biomarker': 'HER2 negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: advanced unresectable gastric or GEJ cancer metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: zolbetuximab with mFOLFOX6; or a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': \"Inclusion Criteria: Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies: Not a woman of child-bearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. Subject has radiologically evaluable disease (measurable and\/or non-measurable disease according to RECIST 1.1), per local assessment, \u2264 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy \u2264 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. Subject's tumor expresses CLDN18.2 in \u2265 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. Subject has ECOG performance status 0 to 1. Subject has predicted life expectancy \u2265 12 weeks. Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility. Hemoglobin (Hgb) \u2265 9 g\/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb \u2265 9 g\/dL. Absolute neutrophil count (ANC) \u2265 1.5 x 10^9\/L Platelets \u2265 100 x 10^9\/L Albumin \u2265 2.5 g\/dL Total bilirubin \u2264 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u2264 2.5 x ULN without liver metastases (or \u2264 5 x ULN if liver metastases are present) Estimated creatinine clearance \u2265 30 mL\/min Prothrombin time (PT)\/international normalized ratio (INR) and partial thromboplastin time (PTT) \u2264 1.5 x ULN (except for subjects receiving anticoagulation therapy)\", 'Exclusion Criteria': 'Exclusion Criteria: Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \u2264 14 days prior to randomization and has not recovered from any related toxicity. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. Subject has received other investigational agents or devices within 28 days prior to randomization. Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6. Subject has known dihydropyrimidine dehydrogenase deficiency. Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\/recurrent vomiting. Subject has significant gastric bleeding and\/or untreated gastric ulcers that would exclude the subject from participation. Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible. Subjects treated for HCV with undetectable viral load results are eligible. Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. Subject has significant cardiovascular disease, including any of the following: Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization. History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects History or family history of congenital long QT syndrome Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible). Subject has a history of central nervous system metastases and\/or carcinomatous meningitis from gastric\/GEJ cancer. Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality. Subject has had a major surgical procedure \u2264 28 days prior to randomization. Subject is without complete recovery from a major surgical procedure \u2264 14 days prior to randomization. Subject has psychiatric illness or social situations that would preclude study compliance. Subject has another malignancy for which treatment is required. Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.'}","output":"{'Arm - Disease - Biomarker': 'CLDN18.2-Positive, HER2-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: advanced unresectable gastric or GEJ cancer metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: zolbetuximab with mFOLFOX6; or a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': \"Inclusion Criteria: Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies: Not a woman of child-bearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. Subject has radiologically evaluable disease (measurable and\/or non-measurable disease according to RECIST 1.1), per local assessment, \u2264 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy \u2264 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. Subject's tumor expresses CLDN18.2 in \u2265 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. Subject has ECOG performance status 0 to 1. Subject has predicted life expectancy \u2265 12 weeks. Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility. Hemoglobin (Hgb) \u2265 9 g\/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb \u2265 9 g\/dL. Absolute neutrophil count (ANC) \u2265 1.5 x 10^9\/L Platelets \u2265 100 x 10^9\/L Albumin \u2265 2.5 g\/dL Total bilirubin \u2264 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u2264 2.5 x ULN without liver metastases (or \u2264 5 x ULN if liver metastases are present) Estimated creatinine clearance \u2265 30 mL\/min Prothrombin time (PT)\/international normalized ratio (INR) and partial thromboplastin time (PTT) \u2264 1.5 x ULN (except for subjects receiving anticoagulation therapy)\", 'Exclusion Criteria': 'Exclusion Criteria: Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \u2264 14 days prior to randomization and has not recovered from any related toxicity. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. Subject has received other investigational agents or devices within 28 days prior to randomization. Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6. Subject has known dihydropyrimidine dehydrogenase deficiency. Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\/recurrent vomiting. Subject has significant gastric bleeding and\/or untreated gastric ulcers that would exclude the subject from participation. Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible. Subjects treated for HCV with undetectable viral load results are eligible. Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. Subject has significant cardiovascular disease, including any of the following: Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization. History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects History or family history of congenital long QT syndrome Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible). Subject has a history of central nervous system metastases and\/or carcinomatous meningitis from gastric\/GEJ cancer. Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality. Subject has had a major surgical procedure \u2264 28 days prior to randomization. Subject is without complete recovery from a major surgical procedure \u2264 14 days prior to randomization. Subject has psychiatric illness or social situations that would preclude study compliance. Subject has another malignancy for which treatment is required. Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.'}","output":"{'Arm - Disease - Biomarker': 'CLDN18.2-Positive, HER2-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080\/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R\/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080\/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Has histologically confirmed diagnosis of R\/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1\/Stage IV. Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib\/placebo, or refrain from heterosexual intercourse during this period Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib\/placebo, whichever occurs last Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. Has adequately controlled blood pressure with or without antihypertensive medications. Has adequate organ function.', 'Exclusion Criteria': \"Exclusion Criteria: Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (\u2265Grade 3) or lenvatinib. Has pre-existing \u2265Grade 3 gastrointestinal or non-gastrointestinal fistula. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident\/transient ischemic attack (TIA)\/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability. Has disease that is suitable for local therapy administered with curative intent. Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. Has had major surgery within 3 weeks before to first dose of study interventions. Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube. Has received prior therapy with lenvatinib or pembrolizumab. Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention. Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has known active central nervous system (CNS) metastases and\/or carcinomatous meningitis. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.). Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention. Has had an allogenic tissue\/solid organ transplant. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\"}","output":"{'Arm - Disease - Biomarker': 'PD-L1 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080\/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R\/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080\/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Has histologically confirmed diagnosis of R\/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1\/Stage IV. Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib\/placebo, or refrain from heterosexual intercourse during this period Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib\/placebo, whichever occurs last Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. Has adequately controlled blood pressure with or without antihypertensive medications. Has adequate organ function.', 'Exclusion Criteria': \"Exclusion Criteria: Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (\u2265Grade 3) or lenvatinib. Has pre-existing \u2265Grade 3 gastrointestinal or non-gastrointestinal fistula. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident\/transient ischemic attack (TIA)\/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability. Has disease that is suitable for local therapy administered with curative intent. Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. Has had major surgery within 3 weeks before to first dose of study interventions. Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube. Has received prior therapy with lenvatinib or pembrolizumab. Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention. Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has known active central nervous system (CNS) metastases and\/or carcinomatous meningitis. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.). Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention. Has had an allogenic tissue\/solid organ transplant. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\"}","output":"{'Arm - Disease - Biomarker': 'PD-L1 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080\/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R\/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080\/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria: - Has histologically confirmed diagnosis of R\/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1\/Stage IV. - Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib\/placebo, or refrain from heterosexual intercourse during this period Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib\/placebo, whichever occurs last Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. Has adequately controlled blood pressure with or without antihypertensive medications. Has adequate organ function.', 'Exclusion Criteria': \"Exclusion Criteria: Has any evidence of symptoms or signs of active tumor bleeding within 6 months before randomization. Has radiographic evidence of major blood vessel invasion\/infiltration or tumor demonstrates >90 degree abutment or encasement of a major blood vessel. Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\/necrosis after lenvatinib therapy. Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer. Has ulceration and\/or fungation of disease onto the skin surface. Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (\u2265Grade 3) or lenvatinib. Has pre-existing \u2265Grade 3 gastrointestinal or non-gastrointestinal fistula. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident\/transient ischemic attack (TIA)\/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability. Has disease that is suitable for local therapy administered with curative intent. Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. Has had major surgery within 3 weeks before to first dose of study interventions. Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube. Has received prior therapy with lenvatinib or pembrolizumab. Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention. Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has known active central nervous system (CNS) metastases and\/or carcinomatous meningitis. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.). Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention. Has had an allogenic tissue\/solid organ transplant. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\"}","output":"{'Arm - Disease - Biomarker': 'PD-L1 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080\/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R\/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080\/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria: - Has histologically confirmed diagnosis of R\/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1\/Stage IV. - Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib\/placebo, or refrain from heterosexual intercourse during this period Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib\/placebo, whichever occurs last Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. Has adequately controlled blood pressure with or without antihypertensive medications. Has adequate organ function.', 'Exclusion Criteria': \"Exclusion Criteria: Has any evidence of symptoms or signs of active tumor bleeding within 6 months before randomization. Has radiographic evidence of major blood vessel invasion\/infiltration or tumor demonstrates >90 degree abutment or encasement of a major blood vessel. Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\/necrosis after lenvatinib therapy. Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer. Has ulceration and\/or fungation of disease onto the skin surface. Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (\u2265Grade 3) or lenvatinib. Has pre-existing \u2265Grade 3 gastrointestinal or non-gastrointestinal fistula. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident\/transient ischemic attack (TIA)\/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability. Has disease that is suitable for local therapy administered with curative intent. Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. Has had major surgery within 3 weeks before to first dose of study interventions. Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube. Has received prior therapy with lenvatinib or pembrolizumab. Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention. Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has known active central nervous system (CNS) metastases and\/or carcinomatous meningitis. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.). Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention. Has had an allogenic tissue\/solid organ transplant. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\"}","output":"{'Arm - Disease - Biomarker': 'PD-L1 mutation'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months', 'Brief Summary': 'Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)\/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision. Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles. Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination. The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.', 'Condition': 'Recurrent Ovarian Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Patients \u2265 18 years old Life expectancy \u22653 months Signed informed consent and ability to comply with treatment and follow-up Histologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. Breast Cancer (BRCA) mutational status is known (germline or somatic) Relapsed disease more than 6 months after the last platinum dose No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen At least one measurable lesion to assess response by RECIST v1.1 criteria. Mandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population: If the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, an FFPE sample from archival tissue may be acceptable after approval of the sponsor. Bone metastases, fine needle aspiration, brushing, cCell pellet from pleural effusion, or ascites or lavage are not acceptable. Two additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or \"de novo\" tissue sample for biomarkers must also be available. Performance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1 Normal organ and bone marrow function: Haemoglobin \u226510.0 g\/dL Absolute neutrophil count (ANC) \u22651.5 x 109\/L Lymphocyte count \u22650.5 \u00d7 109\/L Platelet count \u2265100 x 109\/L Total bilirubin \u22641.5 x institutional upper limit of normal (ULN) Serum albumin \u22652.5 g\/dL Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \u22642.5 x ULN, unless liver metastases are present in which case they must be \u22645 x ULN Serum creatinine \u22641.5 x institutional ULN or calculated creatinine clearance \u2265 30 mL\/min using the Cockcroft-Gault equation Patients not receiving anticoagulant medication must have an International Normalized Ratio (INR) \u22641.5 and an Activated ProThrombin Time (aPTT) \u22641.5 x ULN. Negative Test Results for Hepatitis. Toxicities related to previous treatments must be recovered to < grade 2 Female participants must be postmenopausal or surgically sterile or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum. Ovarian tumors of low malignant potential or low grade Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS) Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered (Grade \u2265 2) from the effects of any major surgery at randomization Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1 Administration of other chemotherapy drugs, anticancer therapy or anti-neoplastic hormonal therapy, or treatment with other investigational agents or devices within 28 days prior to randomization, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, or anticipation to do it during the trial treatment period (non-investigational hormonal replacement therapy is permitted) Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomization or patients who have not completely recovered (Grade \u2265 2) from the effects of previous radiotherapy Current or recent (within 10 days prior to randomization) chronic use of aspirin (>325 mg\/day) or clopidogrel (>75 mg\/day) Clinically significant (e.g. active) cardiovascular disease Resting ECG with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome Left ventricular ejection fraction defined by multigated acquisition\/echocardiogram (MUGA\/ECHO) below the institutional lower limit of normal History or clinical suspicion of brain metastases or spinal cord compression. CT\/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression History or evidence upon neurological examination of central nervous system (CNS) disorders (e.g. uncontrolled epileptic seizures) unless adequately treated with standard medical therapy Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed Uncontrolled hypercalcemia (>1.5 mmol\/L ionized calcium or calcium >12 mg\/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications Pregnant or lactating women Simultaneously receiving therapy in any interventional clinical trial Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-\u03b1) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sj\u00f6gren's syndrome, Guillain-Barr\u00e9 syndrome, multiple sclerosis, vasculitis, or glomerulonephritis History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Active tuberculosis Administration of a live, attenuated vaccine (including against influenza) within 4 weeks prior to Cycle 1, Day 1 or anticipation that it will be administered at any time during the treatment period of the study or within 5 months after the final dose of atezolizumab. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation or allergy to any of the other drugs included in the protocol or their solvents (including to Cremophor\u00ae) Patient has received prior treatment with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor in the recurrent setting or has participated in a study where any treatment arm included administration of a PARP inhibitor in the recurrent setting, unless the patient is unblinded and there is evidence of not having received a PARP inhibitor. Patients that received PARP inhibitor as front line are eligible for the study. The duration of exposure to PARPi following front line therapy needs to be \u226518 months for BRCA mutated patients and \u2265 12 months for BRCA wild type patients. Patient has had any known \u2265Grade 3 hematological toxicity anemia, neutropenia or thrombocytopenia due to prior cancer chemotherapy that persisted >4 weeks and was related to the most recent treatment Patient has any known history or current diagnosis of Myelodysplasic syndrome (MDS) or Anaplastic Myeloid Leukemia (AML) Previous allogeneic bone marrow transplant or previous solid organ transplantation Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment Participant has any known hypersensitivity to niraparib components or excipients\"}","output":"{'Arm - Disease - Biomarker': 'BRCA mutational status'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months', 'Brief Summary': 'Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)\/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision. Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles. Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination. The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.', 'Condition': 'Recurrent Ovarian Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Patients \u2265 18 years old Life expectancy \u22653 months Signed informed consent and ability to comply with treatment and follow-up Histologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. Breast Cancer (BRCA) mutational status is known (germline or somatic) Relapsed disease more than 6 months after the last platinum dose No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen At least one measurable lesion to assess response by RECIST v1.1 criteria. Mandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population: If the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, an FFPE sample from archival tissue may be acceptable after approval of the sponsor. Bone metastases, fine needle aspiration, brushing, cCell pellet from pleural effusion, or ascites or lavage are not acceptable. Two additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or \"de novo\" tissue sample for biomarkers must also be available. Performance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1 Normal organ and bone marrow function: Haemoglobin \u226510.0 g\/dL Absolute neutrophil count (ANC) \u22651.5 x 109\/L Lymphocyte count \u22650.5 \u00d7 109\/L Platelet count \u2265100 x 109\/L Total bilirubin \u22641.5 x institutional upper limit of normal (ULN) Serum albumin \u22652.5 g\/dL Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \u22642.5 x ULN, unless liver metastases are present in which case they must be \u22645 x ULN Serum creatinine \u22641.5 x institutional ULN or calculated creatinine clearance \u2265 30 mL\/min using the Cockcroft-Gault equation Patients not receiving anticoagulant medication must have an International Normalized Ratio (INR) \u22641.5 and an Activated ProThrombin Time (aPTT) \u22641.5 x ULN. Negative Test Results for Hepatitis. Toxicities related to previous treatments must be recovered to < grade 2 Female participants must be postmenopausal or surgically sterile or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.', 'Exclusion Criteria': \"Exclusion Criteria: Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum. Ovarian tumors of low malignant potential or low grade Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS) Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered (Grade \u2265 2) from the effects of any major surgery at randomization Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1 Administration of other chemotherapy drugs, anticancer therapy or anti-neoplastic hormonal therapy, or treatment with other investigational agents or devices within 28 days prior to randomization, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, or anticipation to do it during the trial treatment period (non-investigational hormonal replacement therapy is permitted) Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomization or patients who have not completely recovered (Grade \u2265 2) from the effects of previous radiotherapy Current or recent (within 10 days prior to randomization) chronic use of aspirin (>325 mg\/day) or clopidogrel (>75 mg\/day) Clinically significant (e.g. active) cardiovascular disease Resting ECG with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome Left ventricular ejection fraction defined by multigated acquisition\/echocardiogram (MUGA\/ECHO) below the institutional lower limit of normal History or clinical suspicion of brain metastases or spinal cord compression. CT\/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression History or evidence upon neurological examination of central nervous system (CNS) disorders (e.g. uncontrolled epileptic seizures) unless adequately treated with standard medical therapy Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed Uncontrolled hypercalcemia (>1.5 mmol\/L ionized calcium or calcium >12 mg\/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications Pregnant or lactating women Simultaneously receiving therapy in any interventional clinical trial Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-\u03b1) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sj\u00f6gren's syndrome, Guillain-Barr\u00e9 syndrome, multiple sclerosis, vasculitis, or glomerulonephritis History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Active tuberculosis Administration of a live, attenuated vaccine (including against influenza) within 4 weeks prior to Cycle 1, Day 1 or anticipation that it will be administered at any time during the treatment period of the study or within 5 months after the final dose of atezolizumab. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation or allergy to any of the other drugs included in the protocol or their solvents (including to Cremophor\u00ae) Patient has received prior treatment with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor in the recurrent setting or has participated in a study where any treatment arm included administration of a PARP inhibitor in the recurrent setting, unless the patient is unblinded and there is evidence of not having received a PARP inhibitor. Patients that received PARP inhibitor as front line are eligible for the study. The duration of exposure to PARPi following front line therapy needs to be \u226518 months for BRCA mutated patients and \u2265 12 months for BRCA wild type patients. Patient has had any known \u2265Grade 3 hematological toxicity anemia, neutropenia or thrombocytopenia due to prior cancer chemotherapy that persisted >4 weeks and was related to the most recent treatment Patient has any known history or current diagnosis of Myelodysplasic syndrome (MDS) or Anaplastic Myeloid Leukemia (AML) Previous allogeneic bone marrow transplant or previous solid organ transplantation Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment Participant has any known hypersensitivity to niraparib components or excipients\"}","output":"{'Arm - Disease - Biomarker': 'BRCA mutational status'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed\/Refractory Synovial Sarcoma', 'Brief Summary': 'This study will include participants with various types of cancer known as soft-tissue sarcomas. Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments. Soft tissue cancers are rare and can occur almost anywhere in the body. Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).', 'Condition': 'Malignant Rhabdoid Tumors (MRT), Rhabdoid Tumors of the Kidney (RTK), Atypical Teratoid Rhabdoid Tumors (ATRT), Selected Tumors With Rhabdoid Features, Synovial Sarcoma, INI1-negative Tumors, Malignant Rhabdoid Tumor of Ovary, Renal Medullary Carcinoma, Epithelioid Sarcoma, Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval), Any Solid Tumor With an EZH2 GOF Mutation', 'Detailed Description': \"This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts: Cohort using tazemetostat 800 mg BID Cohort 1 (Closed for enrollment): malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid rhabdoid tumor (ATRT), and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type (SCCOHT), also known as malignant rhaboid tumor of the ovary (MRTO) Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement Cohort 3 (Closed for enrollment): Other integrase interactor 1 (INI1) negative tumors or any solid tumor with an enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC) Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES) Cohort 6 (Closed for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy Cohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval) Cohort using tazemetostat 1600 mg QD \u2022 Cohort 8 (Closed for enrollment): Epitheliod sarcoma Participants will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study. Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study.\", 'Inclusion Criteria': \"Inclusion Criteria: Age (at the time of consent\/assent): \u226518 years of age Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Has provided signed written informed consent Has a life expectancy of >3 months Has a malignancy: For which there are no standard therapies available (Cohorts 1, 3, 4 and 5) That is relapsed or refractory after treatment with an approved therapy(ies), defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies) (Cohort 2) That has progressed within 6 months prior to study enrollment (Cohort 5 Expansion, Cohort 6 and Cohort 8 ONLY) Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA\/College of American Pathologists (CAP) or equivalent laboratory certification For Cohort 1 (rhabdoid tumors only), the following test results must be available by local laboratory: morphology and immunophenotypic panel consistent with rhabdoid tumors, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable For Cohort 2 (subjects with relapsed\/refractory synovial sarcoma only), the following tests must be available by local laboratory: Morphology consistent with synovial sarcomas, and cytogenetics or fluorescence in situ hybridization (FISH) and\/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11) For Cohort 3, 4, 5, 7 and 8 (subjects with INI1-negative\/aberrant tumors or any solid tumor with EZH2 GOF mutation only), the following test results must be available by local laboratory: Morphology and immunophenotypic panel consistent with INI1-negative tumors (not applicable for solid tumors with EZH2 GOF mutation), and loss of INI1 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable, or molecular evidence of EZH2 GOF mutation For Cohort 6 (subjects with ES undergoing optional tumor biopsy) only: Morphology and immunophenotypic panel consistent with ES (e.g., CD34, EMA, Keratin, and INI1) Has all prior treatment (i.e. chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to \u2264Grade 1 per CTCAE version 4.0.3 or are clinically stable and not clinically significant, at time of enrollment. Prior anti-cancer therapy(ies), if applicable, must be completed according to the criteria below: Chemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat) Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat) Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat) Monoclonal antibody(ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat) Immunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat) Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat\/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat\/At least 12 weeks from craniospinal, \u226550% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat) High dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat) Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat) Has sufficient tumor tissue (slides or blocks) available for central confirmatory testing Has measurable disease based on either RECIST 1.1 for solid tumors or RANO for CNS tumors Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function. For subjects with CNS Tumors only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat Has a shortening fraction of >27% or an ejection fraction of \u226550% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan and New York Heart Association (NYHA) Class \u22642 Has a QT interval corrected by Fridericia's formula (QTcF) \u2264480 msec Female subjects of childbearing potential must: Have a negative beta-human chorionic gonadotropin (\u03b2-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat and Agree to use effective contraception from a minimum of 7 days prior to first dose until 6 months following the last dose of tazemetostat and have a male partner who uses a condom, or Practice true abstinence or have a male partner who is vasectomized Male subjects with a female partner of childbearing potential must: Be vasectomized, or Agree to use condoms as defined in Section 8.6.2, from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or Have a female partner who is NOT of childbearing potential\", 'Exclusion Criteria': 'Exclusion Criteria: Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2) Has participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of tazemetostat Has known active CNS or any leptomeningeal metastasis of primary extra-cranial tumor. Has had a prior malignancy other than the malignancies under study - EXCEPTION: A subject who has been disease-free for 5 years, or a subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible Has had major surgery within 3 weeks prior to enrollment Has Thrombocytopenia, neutropenia, or anemia of Grade \u22653 (per CTCAE 4.03 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS). Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing. Has a prior history of T-LBL \/T-ALL Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet Has cardiovascular impairment, history of congestive heart failure greater than NYHA Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the planned first dose of tazemetostat; or ventricular cardiac arrhythmia requiring medical treatment Is currently taking any prohibited medication(s) Has an active infection requiring systemic treatment Is immunocompromised (i.e. has congenital immunodeficiency), including subjects known history of infection with human immunodeficiency virus (HIV) Has known active infection with hepatitis B virus or hepatitis C virus Has had a symptomatic venous thrombosis within 2 weeks prior to study enrollment - For subjects with CNS involvement (primary tumor or metastatic disease), have any active bleeding or new intratumoral hemorrhage of more than punctuate size of screening MRI obtained within 14 days of starting study drug or known bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents Has known hypersensitivity to any of the component of tazemetostat or other inhibitor(s)of EZH2 Is unable to take oral medications, or has a malabsorption syndrome or any uncontrolled gastrointestinal condition (e.g., nausea, diarrhea or vomiting) that would limit compliance with study requirements. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness\/social situations that would limit compliance with study requirements. For female subjects of childbearing potential: Is pregnant or nursing For male subjects: Is unwilling to adhere to contraception criteria from time of enrollment in the study to at least 3 months after last dose of tazemetostat.'}","output":"{'Arm - Disease - Biomarker': 'EZH2 Inhibitor, INI1-Negative'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Na\u00efve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151) ', 'Brief Summary': \"This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase. \", 'Condition': 'Carcinoma, Non-Small-Cell Lung ', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed Stage IV non-squamous NSCLC No prior treatment for Stage IV non-squamous NSCLC, with the following exceptions: (1) Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or were intolerant to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib, or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC. Patients who have progressed on or were intolerant to first-line osimertinib or other third-generation EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and who have no evidence of the EGFR T790M mutation in the tumor tissue after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation in their tumor tissue must have also progressed on or were intolerant to osimertinib to be eligible. (2) Patients with an ALK gene rearrangement must have experienced disease progression or were intolerant to treatment with one or more ALK inhibitors, such as crizotinib, alectinib, ceritinib, brigatinib, ensartinib and lorlatinib that are appropriate for the treatment of NSCLC that has an ALK gene rearrangement. Availability of a representative tumor specimen that is suitable for the determination of PD-L1 status, as well as the presence of EGFR mutations and ALK gene rearrangements, via central testing. Treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy treatment for patients who have received prior neoadjuvant and\/or adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy >=3 months Adequate hematologic and end-organ function Negative HIV test at screening Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm', 'Exclusion Criteria': 'Exclusion Criteria: Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Active tuberculosis Significant cardiovascular disease Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death Prior allogeneic stem cell or solid organ transplantation Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab Current treatment with anti-viral therapy for HBV Treatment with any approved anti-cancer therapy or investigational therapy within 28 days prior to initiation of study treatment, except for treatment with TKI that should be discontinued for at least 8 days or for approximately 5 x half-life, whichever is the longer, before the first dose of study treatment Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose of bevacizumab, carboplatin, pemetrexed, and paclitaxel'}","output":"{'Arm - Disease - Biomarker': 'Include: Sensitizing mutation in the EGFR gene progressive during or after treatment\/or intolerant to one or more EGFR TKIs, ALK gene rearrangement progressive\/intolerant to one or more ALK inhibitors'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Na\u00efve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151) ', 'Brief Summary': \"This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase. \", 'Condition': 'Carcinoma, Non-Small-Cell Lung ', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria: Histologically or cytologically confirmed Stage IV non-squamous NSCLC No prior treatment for Stage IV non-squamous NSCLC, with the following exceptions: (1) Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or were intolerant to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib, or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC. Patients who have progressed on or were intolerant to first-line osimertinib or other third-generation EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and who have no evidence of the EGFR T790M mutation in the tumor tissue after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation in their tumor tissue must have also progressed on or were intolerant to osimertinib to be eligible. (2) Patients with an ALK gene rearrangement must have experienced disease progression or were intolerant to treatment with one or more ALK inhibitors, such as crizotinib, alectinib, ceritinib, brigatinib, ensartinib and lorlatinib that are appropriate for the treatment of NSCLC that has an ALK gene rearrangement. Availability of a representative tumor specimen that is suitable for the determination of PD-L1 status, as well as the presence of EGFR mutations and ALK gene rearrangements, via central testing. Treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy treatment for patients who have received prior neoadjuvant and\/or adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy >=3 months Adequate hematologic and end-organ function Negative HIV test at screening Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm', 'Exclusion Criteria': 'Exclusion Criteria: Symptomatic, untreated, or actively progressing CNS metastases History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Active tuberculosis Significant cardiovascular disease Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death Prior allogeneic stem cell or solid organ transplantation Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab Current treatment with anti-viral therapy for HBV Treatment with any approved anti-cancer therapy or investigational therapy within 28 days prior to initiation of study treatment, except for treatment with TKI that should be discontinued for at least 8 days or for approximately 5 x half-life, whichever is the longer, before the first dose of study treatment Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose of bevacizumab, carboplatin, pemetrexed, and paclitaxel'}","output":"{'Arm - Disease - Biomarker': 'Include: Sensitizing mutation in the EGFR gene progressive during or after treatment\/or intolerant to one or more EGFR TKIs, ALK gene rearrangement progressive\/intolerant to one or more ALK inhibitors'}"},{"prompt":"Biomarker Extraction Guideline\n\n1. Review the \u201carms data\u201d and identify the biomarker from the clinical trial arm.\n\n2. Rely only on \"arms data\" to identify the biomarker. The \"arms data\" may be incomplete or irrelevant. You should not make assumptions about the \"arms data\" beyond what is mentioned.\n\n3. Make sure to extract only the biomarker information.\n\n4. Avoid any other additional context.\n\n5. Return just the biomarker. Do not write a para.\n\n6. Refer to these examples for formatting: Return Biomarker - HR+, HER2-\n","instruction":"{'Official Title': 'A Phase 1B\/2 Study of Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE) ', 'Brief Summary': 'This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents. ', 'Condition': 'HER2-positive Advanced Gastric Cancer ', 'Detailed Description': 'Trastuzumab has been administered at 6 mg\/kg every 3 weeks after initial loading of 8 mg\/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg\/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg\/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg\/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg\/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg\/m2. Administration of this drug is set as one cycle of 4 weeks. ', 'Inclusion Criteria': 'Inclusion Criteria: HER2-positive advanced gastric cancer Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal \u2265 2.0) or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring) Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer Patients who are willing and able to write a written consent form for this trial. Patients aged 19 years or older at the time of signing the subject consent form. Patients with measurable or evaluable lesions according to RECIST 1.1. ECOG activity status 0, 1 or 2 as patients with adequate organ function Absolute neutrophil (ANC) \u22651.0 x 109\/L, platelet \u2265100 x 109\/L, hemoglobin \u22659 g\/dL, serum creatinine \u22641.5 x ULN, total bilirubin \u22643.0 mg on laboratory tests within 2 weeks before starting treatment \/dL, AST\/ALT \u22645 x ULN Echocardiogram EF \u226555% or MUGA scan \u226550%', 'Exclusion Criteria': \"Exclusion Criteria: Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with Patients with a history of gastrointestinal perforation or fistula within 6 months. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer\"}","output":"{'Arm - Disease - Biomarker': 'HER2-positive'}"}]