Actively Recruiting
Phase 12 Study of REGN5093 for Adults With Advanced MET-Altered Non-Small Cell Lung Cancer
Led by Regeneron Pharmaceuticals · Updated on 2026-06-17
231
Participants Needed
40
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating REGN5093 for treating advanced Non-Small Cell Lung Cancer NSCLC with MET alteration. The study aims to determine the safety, tolerability, and effectiveness of REGN5093. The trial includes two phases Phase 1 focuses on finding a safe dose of REGN5093, and Phase 2 uses that dose to assess how well REGN5093 shrinks tumors and affects cancer progression. Participants will receive REGN5093 through intravenous infusion. The study starts with dose escalation cohorts in Phase 1, followed by an expansion phase in Phase 2. The treatment is given as a monotherapy, and dosing schedules are designed to find an appropriate and safe dose and then evaluate its impact on the disease. During the study, participants will be closely monitored for side effects, blood levels of REGN5093, and tumor response using RECIST 1.1 criteria. Researchers will record safety data, including treatment-emergent adverse events and serious adverse events, over an average of 12 years. Outcomes like objective response rate, duration of response, disease control rate, progression-free survival, and overall survival will be measured to understand the long-term effects and safety of REGN5093.
CONDITIONS
Brief Title
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
Research Team
C
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