What is this study studying for advanced non-small cell lung cancer?

This study is investigating how well combinations of targeted drugs work for advanced non-small cell lung cancer with specific EGFR and MET gene changes. It aims to find out if adding ramucirumab to capmatinib and osimertinib can improve treatment outcomes. The research is sponsored by the SWOG Cancer Research Network and focuses on patients whose cancer has progressed after prior therapies.

Who may be eligible for this advanced non-small cell lung cancer clinical trial?

Adults 18 years or older with non-small cell lung cancer that has EGFR mutation and MET amplification who have progressed after osimertinib treatment may be eligible. Participants must be able to swallow tablets and have stable health measures such as blood counts and heart function. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced non-small cell lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05642572

A Randomized Phase II Study of Capmatinib Plus Osimertinib With or Without Ramucirumab in Patients With EGFR-Mutant, MET-Amplified Advanced Non-Small Cell Lung Cancer

Led by SWOG Cancer Research Network · Updated on 2026-06-03

Participants Needed

454

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients must meet common Lung-MAP eligibility criteria and be assigned to the S1900G sub-study
Have non-small cell lung cancer with a sensitizing EGFR mutation
Have radiological or clinical progression on osimertinib as their most recent therapy
Have MET amplification confirmed by tissue or blood testing after progression on osimertinib
Have measurable or non-measurable disease documented by CT or MRI
Have brain imaging within 42 days prior to randomization
Be neurologically stable if symptomatic brain metastases are present
Have recovered from prior therapy side effects except hair loss or vitiligo
Able to swallow tablets whole
Meet specific blood count and organ function requirements within 28 days prior to randomization
Have performance status of 0-1
Have ECG with QTcF ≤ 470 msec
Agree to provide blood samples for circulating tumor DNA and specimen banking
Provide informed consent

You will not qualify if you...

Previously received anti-VEGF, VEGFR, or MET inhibitors
Received any anti-cancer drug other than osimertinib within 21 days prior to randomization
Received radiation therapy within 14 days prior to randomization
Planning to receive other concurrent cancer therapies during the study
Had major surgery within 14 days prior to randomization and not fully recovered
Received live attenuated vaccines within 28 days prior to randomization
Using strong CYP3A4 inducers or inhibitors or drugs that prolong QT interval within 7 days prior to registration
Have uncontrolled high blood pressure within 28 days prior to randomization
Have other malignancies that may interfere with study assessments
Are pregnant or breastfeeding, or unwilling to use effective contraception if of reproductive potential

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