Targeted Treatment for Advanced Non-Small Cell Lung Cancer with a MET Gene Change

Program Overview

This study is testing a new treatment for advanced non-small cell lung cancer (NSCLC) that has a specific gene change known as MET exon 14 skipping. The trial is investigating whether the drug tepotinib, alone or combined with ramucirumab, can help slow down or stop the cancer from growing or spreading. Tepotinib works by blocking a protein that helps cancer cells multiply, while ramucirumab may prevent the growth of new blood vessels that tumors need to grow. The study aims to find out if this combination can improve outcomes for patients with stage IV or recurrent NSCLC.

Description

The main goal of this study is to compare how well patients with MET exon 14 skipping positive NSCLC respond to tepotinib, with or without ramucirumab. Researchers will look at how many patients experience a reduction in their cancer, how long they live without the cancer getting worse, and their overall survival. They will also monitor any side effects, such as swelling, and collect tissue and blood samples for further research.

Participants will be randomly assigned to one of two groups:

• Group A: Patients will receive ramucirumab through an IV and take tepotinib pills daily. This cycle repeats every 21 days as long as the treatment is effective and side effects are manageable.
• Group B: Patients will take tepotinib pills daily. This cycle also repeats every 21 days under the same conditions.

Throughout the trial, participants will have scans and blood tests to monitor their cancer and overall health. After finishing the study treatment, they will have follow-up visits every 12 weeks, and then every 6 months for up to 3 years.

Eligibility Criteria

Locations