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Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

Primary Purpose

Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Biospecimen Collection
Computed Tomography
Lymphoscintigraphy
Magnetic Resonance Imaging
Ramucirumab
Tepotinib
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Lung Non-Small Cell Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol Participants must have documentation of NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be: NGS test results from tissue submitted for LUNGMAP screening, or Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test NOTE: Participants previously tested for and determined to have a MET exon 14 skipping mutation, outside of LUNGMAP, must also submit tissue for central Foundation Medicine (FMI) testing on the LUNGMAP screening protocol, if available Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless: Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC Participants must have recovered (=< grade 1) from any side effects of prior therapy except alopecia and vitiligo Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib). Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab) Participants must not have a history of interstitial lung disease that required steroid treatment Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator 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 Participants must be able to swallow tablets whole Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to sub-study randomization) Hemoglobin >= 9.0 g/dL (within 28 days prior to sub-study randomization) Platelets >= 100 x 10^3/uL (within 28 days prior to sub-study randomization) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to sub-study randomization) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 × institutional ULN. Participants with history of liver metastasis must have AST =< 5 x ULN (within 28 days prior to sub-study randomization) Participants must have a serum creatinine =< the institutional upper limit of normal (IULN) or calculated creatinine clearance >= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization Participants must have a completed medical history and physical exam within 28 days prior to sub-study 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 using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study randomization Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis Participants must not have grade < 0 of peripheral edema within 28 days prior to sub-study randomization Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen Participants must have a Lymphoscintigraphy scan performed within 28 days prior to sub-study randomization Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm A: (Ramucirumab and tepotinib)

    Arm B: (Tepotinib)

    Arm Description

    Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

    Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

    Outcomes

    Primary Outcome Measures

    Response rate
    Rates will be compared using a chi-squared test at the 1-sided 10% level and also presented as the difference in response rates with the associated 80% confidence interval for the difference, Further, response rates and associated 80% confidence interval will be estimated for each arm.

    Secondary Outcome Measures

    Frequency of treatment-related peripheral edema
    The frequency of peripheral edema will be compared using a 2-sided 10% level test of proportions. All-grade peripheral edema will be estimated along with 90% confidence intervals. Data from lymphoscintigraphy imaging will be summarized for baseline and among those with peripheral edema.
    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
    The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 within each treatment arm will be evaluated.
    Progression-free survival
    Will be estimated using the method of Kaplan-Meier. Will be compared between the arms using a 1-sided 10% level log-rank test. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
    Overall survival
    Will be estimated using the method of Kaplan-Meier. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
    Duration of response
    Will be estimated using the method of Kaplan-Meier. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    September 7, 2023
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06031688
    Brief Title
    Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
    Official Title
    A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 6, 2024 (Anticipated)
    Primary Completion Date
    May 31, 2028 (Anticipated)
    Study Completion Date
    May 31, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.
    Detailed Description
    PRIMARY OBJECTIVE: I. To compare the response rate (confirmed or unconfirmed, complete or impartial) between participants with MET exon 14 skipping positive non-small cell lung cancer (NSCLC) randomized to tepotinib with or without ramucirumab. SECONDARY OBJECTIVES: I. To compare the frequency of all-grade treatment- related peripheral edema as defined by Common Terminology Criteria for Adverse Events (CTCAE) between the arms. II. To evaluate the frequency and severity of toxicities within each arm. III. To compare progression-free survival between the arms. IV. To compare overall survival between the arms. V. To estimate the duration of response (DoR) among responders within each arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To establish a tissue/blood repository for participants with MET exon 14 skipping non-small cell lung cancer (NSCLC). OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive ramucirumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and tepotinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood sample collection while on study. After completion of study treatment, patients are followed-up every 12 weeks or more often as clinically indicated until progression and then every 6 months for 2 years and at the end of 3 years from date of sub-study randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A: (Ramucirumab and tepotinib)
    Arm Type
    Experimental
    Arm Description
    Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
    Arm Title
    Arm B: (Tepotinib)
    Arm Type
    Active Comparator
    Arm Description
    Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
    Intervention Type
    Procedure
    Intervention Name(s)
    Biospecimen Collection
    Other Intervention Name(s)
    Biological Sample Collection, Biospecimen Collected, Specimen Collection
    Intervention Description
    Undergo blood sample collection
    Intervention Type
    Procedure
    Intervention Name(s)
    Computed Tomography
    Other Intervention Name(s)
    CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
    Intervention Description
    Undergo CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    Lymphoscintigraphy
    Intervention Description
    Undergo lymphoscintigraphy scan
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic Resonance Imaging
    Other Intervention Name(s)
    Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
    Intervention Description
    Undergo MRI
    Intervention Type
    Biological
    Intervention Name(s)
    Ramucirumab
    Other Intervention Name(s)
    Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    Tepotinib
    Other Intervention Name(s)
    c-Met Inhibitor MSC2156119J, EMD 1214063, EMD-1214063, EMD1214063, MSC2156119J
    Intervention Description
    Given PO
    Primary Outcome Measure Information:
    Title
    Response rate
    Description
    Rates will be compared using a chi-squared test at the 1-sided 10% level and also presented as the difference in response rates with the associated 80% confidence interval for the difference, Further, response rates and associated 80% confidence interval will be estimated for each arm.
    Time Frame
    Up to 3 years from date of sub-study randomization
    Secondary Outcome Measure Information:
    Title
    Frequency of treatment-related peripheral edema
    Description
    The frequency of peripheral edema will be compared using a 2-sided 10% level test of proportions. All-grade peripheral edema will be estimated along with 90% confidence intervals. Data from lymphoscintigraphy imaging will be summarized for baseline and among those with peripheral edema.
    Time Frame
    Up to 3 years from date of sub-study randomization
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
    Description
    The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 within each treatment arm will be evaluated.
    Time Frame
    Up to 3 years from date of sub-study randomization
    Title
    Progression-free survival
    Description
    Will be estimated using the method of Kaplan-Meier. Will be compared between the arms using a 1-sided 10% level log-rank test. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
    Time Frame
    From date of sub-study randomization to date of first documentation of progression or death due to any cause, assessed up to 3 years
    Title
    Overall survival
    Description
    Will be estimated using the method of Kaplan-Meier. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
    Time Frame
    Up to 3 years from date of sub-study randomization
    Title
    Duration of response
    Description
    Will be estimated using the method of Kaplan-Meier. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
    Time Frame
    From date of first documentation of response (complete response [CR] or partial response [PR]) to date of first documentation of progression or death due to any cause among participants who achieve a response (CR or PR), assessed up to 3 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol Participants must have documentation of NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be: NGS test results from tissue submitted for LUNGMAP screening, or Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test NOTE: Participants previously tested for and determined to have a MET exon 14 skipping mutation, outside of LUNGMAP, must also submit tissue for central Foundation Medicine (FMI) testing on the LUNGMAP screening protocol, if available Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless: Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC Participants must have recovered (=< grade 1) from any side effects of prior therapy except alopecia and vitiligo Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib). Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab) Participants must not have a history of interstitial lung disease that required steroid treatment Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator 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 Participants must be able to swallow tablets whole Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to sub-study randomization) Hemoglobin >= 9.0 g/dL (within 28 days prior to sub-study randomization) Platelets >= 100 x 10^3/uL (within 28 days prior to sub-study randomization) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to sub-study randomization) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 × institutional ULN. Participants with history of liver metastasis must have AST =< 5 x ULN (within 28 days prior to sub-study randomization) Participants must have a serum creatinine =< the institutional upper limit of normal (IULN) or calculated creatinine clearance >= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization Participants must have a completed medical history and physical exam within 28 days prior to sub-study 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 using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study randomization Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis Participants must not have grade < 0 of peripheral edema within 28 days prior to sub-study randomization Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen Participants must have a Lymphoscintigraphy scan performed within 28 days prior to sub-study randomization Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul K Paik
    Organizational Affiliation
    SWOG Cancer Research Network
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

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