Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer with EGFR and MET Gene Changes

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05642572

Provider View

This clinical trial is testing different combinations of targeted drugs to treat advanced non-small cell lung cancer (NSCLC) that has specific gene changes in EGFR and MET. The study aims to find out if these drug combinations can help shrink or stabilize the cancer.

Patient Parameters

Program Overview

This study is exploring the use of targeted drugs, capmatinib, osimertinib, and ramucirumab, to treat advanced non-small cell lung cancer (NSCLC) with specific gene changes in EGFR and MET. These drugs work by blocking proteins that help cancer cells grow and spread. The goal is to see if these combinations can effectively shrink tumors or stop them from growing.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when treated with different combinations of the drugs capmatinib, osimertinib, and ramucirumab. The study will also look at the safety of these drug combinations and how well they work in patients with specific gene changes in their cancer.

Patients will be randomly assigned to one of two groups:

  • Group A: Patients will take capmatinib and osimertinib by mouth and receive ramucirumab through an IV. They will also have regular scans and blood tests.
  • Group B: Patients will take capmatinib and osimertinib by mouth. They will also have regular scans and blood tests.

The study will collect blood samples to study the cancer's genetic material and create a tissue and blood sample bank for future research. The study will also track how long patients live, how their cancer responds to treatment, and any side effects they experience.

Eligibility Criteria

Inclusion Criteria

  • Must meet specific eligibility criteria for the Lung-MAP study.
  • Must be assigned to the S1900G study by the Southwest Oncology Group.
  • Must have non-small cell lung cancer (NSCLC) with an EGFR mutation and have progressed on osimertinib.
  • Must have MET amplification confirmed by specific tests.
  • Must have measurable or non-measurable disease as confirmed by scans.
  • Must have a brain scan to check for cancer spread to the brain.
  • Must be stable if there is cancer in the brain and not need increasing doses of steroids.
  • Must have recovered from previous treatments.
  • Must be able to swallow tablets.
  • Must meet specific blood count and organ function requirements.
  • Must have a recent ECG with a specific heart rate measurement.
  • Must have a recent medical history and physical exam.
  • Must have a recent urinalysis with specific protein levels.
  • Must have specific blood clotting times unless on blood thinners.
  • Must have controlled HIV if applicable.
  • Must have specific enzyme levels in the blood.
  • Must have adequate heart function.
  • Must agree to provide blood samples for research.
  • Must agree to participate in specimen banking.
  • Must understand the study and sign informed consent.
  • Must not have conditions that prevent safe participation.

Exclusion Criteria

  • Must not have received certain drugs targeting VEGF, VEGFR, or MET.
  • Must not have received any cancer drugs (except osimertinib) within 21 days before starting the study.
  • Must not have had radiation therapy within 14 days before starting the study.
  • Must not plan to receive other cancer treatments while on the study.
  • Must not have had major surgery within 14 days before starting the study.
  • Must not have received live vaccines within 28 days before starting the study.
  • Must not take certain medications that affect drug metabolism or heart rhythm.
  • Must not have uncontrolled high blood pressure.
  • Must not have other cancers that could interfere with the study.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception if of reproductive potential.

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