Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping
This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurr
| Condition(s) | Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the |
| Who can participate | Inclusion Criteria: * Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol * Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \[ctDNA\]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be: * NGS test results from tissue submitted for LUNGMAP screening, or * Submitted documentation |
| Ages | 18 Minutes |
| Sex | All |
| Lead sponsor | SWOG Cancer Research Network |
| Locations | Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States (+260 more sites) |
| Start date | 2024-08-08 |
| NCT ID | NCT06031688 |
| Official listing | https://clinicaltrials.gov/study/NCT06031688 |