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Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

ConditionsRecurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol

Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed

Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay. MET amplifications may have been determined based on tissue submitted for testing by Foundation Medicine Inc (FMI) through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib (alone or in combination with another agent[s]). The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/Independent Ethics Committee (IEC), College of American Pathologists (CAP), or similar certification

Disqualifiers

Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor

Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization

Note: osimertinib may continue up to the day prior to study treatment initiation

Participants must not have received any radiation therapy within 14 days prior to sub-study randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Capmatinib

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Osimertinib

    Drug

    Given PO

  • Ramucirumab

    Biological/Vaccine

    Given IV

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Arm A (capmatinib, osimertinib, ramucirumab)Experimental treatment 6 interventions
Group B: Arm B (capmatinib, osimertinib)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Investigator-assessed progression-free survival

Will be estimated using the method of Kaplan-Meier. Medians and their associated 95% confidence intervals will be estimated using the Brookmeyer-Crowley method. Binary proportions and the associated confidence interval will be estimated.

Time frame
From date of sub-study randomization to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Secondary outcomes

1

Duration of response

Will be estimated using the method of Kaplan-Meier. Medians and their associated 95% confidence intervals will be estimated using the Brookmeyer-Crowley method. Binary proportions and the associated confidence interval will be estimated.

Time frame
From date of first documentation of response to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a response, assessed up to 3 years
2

Dose limiting toxicity (DLT)

Treatment-related Grade 3 or higher non hematologic toxicity, treatment-related Grade 4 or higher hematologic toxicity, or any grade of treatment-related toxicity that leads to drug discontinuation. The DLT assessment period is the first cycle of treatment. Treatment related is defined as an attribution of possible, probably, or likely related to treatment. Toxicities to be graded based on Common Terminology Criteria for Adverse Events.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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