Phase Ib Study Evaluating Safety and Effectiveness of JMKX001899 Combined With Other Treatments in Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of JMKX001899 combined with IN10018, chemotherapy, or both in people with locally advanced or metastatic non-small cell lung cancer NSCLC that has the KRAS G12C mutation. This phase 1b study aims to find the right dose and assess how well these combinations work together in this specific patient group. Participants will be assigned to one of three study groups JMKX001899 with IN10018, JMKX001899 with chemotherapy Pemetrexed and Carboplatin, or JMKX001899 with both IN10018 and chemotherapy. JMKX001899 and IN10018 are taken daily as oral tablets, while chemotherapy drugs are given by intravenous infusion every 3 weeks for up to 4 cycles. The study includes dose escalation and expansion phases to evaluate different dosing levels and combinations. During the study, participants will undergo regular assessments to monitor side effects and measure the recommended dose for phase II. Researchers will track adverse events throughout the study, which may last about 2.5 years. Evaluations will include measuring disease response using RECIST 1.1 criteria and monitoring organ function and performance status. The study follows participants closely to understand treatment effects and safety.

A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation