Phase II Study Comparing Tepotinib With or Without Ramucirumab for Advanced or Recurrent Non-Small Cell Lung Cancer With MET Exon 14 Skipping Mutation

What this Trial Is About

This research evaluates treatments for patients with advanced or recurrent non-small cell lung cancer NSCLC that have a specific MET exon 14 skipping gene mutation. It compares the effects of the drug tepotinib alone or combined with ramucirumab. Tepotinib is a kinase inhibitor that blocks abnormal MET protein signals to slow tumor growth, while ramucirumab is an antibody that may prevent tumors from growing new blood vessels. The study is a phase II Expanded Lung-MAP trial focusing on this targeted therapy approach. Participants are randomly assigned to one of two groups. One group receives ramucirumab intravenously on the first day of each 21-day cycle plus daily oral tepotinib for 21 days. The other group receives only daily oral tepotinib for 21 days per cycle. Treatments continue until the cancer worsens or side effects are unacceptable. Optional lymphoscintigraphy scans occur at screening and if peripheral edema develops or worsens. Blood and urine samples are collected, and CT or MRI scans are performed throughout the study. During the trial, patients undergo regular imaging and sample collections to monitor response and side effects, including peripheral edema. After treatment ends, follow-up visits occur every 12 weeks until disease progression, then every 6 months for 2 years, and a final visit at 3 years from randomization. Researchers will measure response rates, treatment-related side effects, progression-free survival, overall survival, and duration of response over up to 3 years. Specimens are also collected for research purposes.

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)