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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Capmatinib — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Osimertinib — DRUG
  Given PO
• Ramucirumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

May 5, 2023

Status verified

Jun 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (capmatinib, osimertinib, ramucirumab)
  Patients receive capmatinib PO, osimertinib PO, and ramucirumab IV on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.
• Experimental: Arm B (capmatinib, osimertinib)
  Patients receive capmatinib PO and osimertinib PO on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.

Primary Outcome Measure

Investigator-assessed progression-free survival [ 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 ]

Locations (454)

Find similar trials in Daphne, AL

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