Study to Evaluate the Safety and Effectiveness of Glumetinib in Adults With Advanced Non-Small Cell Lung Cancer Having MET Alterations

What this Trial Is About

This clinical trial is studying patients with advanced non-small cell lung cancer NSCLC who have specific alterations in the MET gene, including mutations and amplifications. The study focuses on evaluating the effects and safety of Glumetinib, a selective MET inhibitor, in adults with locally advanced or metastatic NSCLC, including pulmonary sarcomatoid carcinoma. This includes patients who have had prior treatments or are not eligible for chemotherapy. The trial is conducted in phases Ib and II with participants from China, the US, and globally. Participants receive Glumetinib orally at a dose of 300 mg once daily while fasting. The Phase Ib portion includes about 90 patients with various MET alterations, while Phase II involves around 78 patients who have METex14 skipping mutations and meet additional criteria related to prior treatments and chemotherapy eligibility. The study allows for a safety run-in group of at least six patients in the US. Treatment continues according to the study protocol to assess response and safety. Throughout the study, participants will undergo regular assessments to monitor tumor response using RECIST 1.1 criteria and to evaluate safety and side effects. Researchers will track objective response rate ORR over about one year, along with duration of response and overall efficacy. Patients must have adequate organ function and performance status to participate. The study includes follow-up visits to observe treatment effects and document any adverse events during and after the treatment period, with a total participation duration aligned with the study completion timeline.

Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer