A Phase III Study of EP0031 Lunbotinib with Chemotherapy in Adults with Advanced RET-altered Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating EP0031 Lunbotinib, a next-generation selective RET inhibitor, in adults with advanced RET-altered non-small cell lung cancer NSCLC. This Phase III study aims to find the optimal dose and assess the safety, side effects, and effectiveness of EP0031 alone and in combination with standard chemotherapy. The study addresses a critical need as no approved RET-targeted treatments exist for patients whose cancer progresses after first-generation selective RET inhibitors SRIs. Participants receive EP0031 capsules once daily at the recommended dose alongside platinum-based doublet chemotherapy on Day 1 of each 21-day cycle, for up to four cycles. Following this, participants continue EP0031 with pemetrexed maintenance until disease progression, unacceptable side effects, or withdrawal. The study includes two groups treatment-naive patients and a now-closed cohort previously treated with a first-generation SRI. The Phase 1 dose escalation has completed, and the study is currently in Phase 2. During the trial, participants undergo regular assessments including tumor measurements using RECIST v1.1 criteria, safety and tolerability monitoring, and pharmacokinetic tests to measure drug levels in the body. Key outcomes include evaluating dose-limiting toxicities within the first 21 days and measuring overall response rates over 12 months. The study continues until March 2028, with ongoing observation of effects and side effects throughout treatment.

A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies