Study on REGN5093 for Treating Advanced Non-Small Cell Lung Cancer with MET Alterations
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT04077099
This clinical trial is testing a new drug, REGN5093, to see if it is safe and effective for treating advanced Non-Small Cell Lung Cancer (NSCLC) with specific genetic changes called MET alterations.
Patient Parameters
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Program Overview
The study aims to find out if REGN5093 is safe and can help shrink tumors in patients with advanced Non-Small Cell Lung Cancer (NSCLC) that has specific genetic changes known as MET alterations. The trial is divided into two phases. Phase 1 focuses on finding a safe dose of REGN5093, while Phase 2 tests how well this dose works to reduce tumors. Researchers will also look at potential side effects, how the drug behaves in the body, and how long it takes to start working.
Eligibility Criteria
Inclusion Criteria
- Have advanced Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body.
- Be willing to provide a sample of tumor tissue for testing.
- Have a confirmed presence of MET alterations in the cancer.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function as determined by specific medical tests.
Exclusion Criteria
- Have received any other cancer treatment or participated in another clinical trial within the last two weeks.
- Have not fully recovered from side effects of previous treatments, with some exceptions.
- Have had radiation therapy or major surgery within the last 14 days.
- Have untreated or active brain tumors, cancer spread to the central nervous system, or spinal cord compression.
- Have an uncontrolled infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 | 92868 | Orange | California |
| Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Moffitt Cancer Center - McKinley Drive | 33612 | Tampa | Florida |
| University of Kentucky, Markey Cancer Center Clinical Research Organization | 40536 | Lexington | Kentucky |
| DNU_Massachusetts General Hospital_DNU | 02114 | Boston | Massachusetts |
| Dana Farber Harvard Cancer Center Consortium | 02215 | Boston | Massachusetts |
| Henry Ford Health System | 48202 | Detroit | Michigan |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| NYU Cancer Institute | 10016 | New York | New York |
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