Study of IBI351 Combined With Chemotherapy for Advanced Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation

What this Trial Is About

Researchers are evaluating the efficacy and safety of IBI351 combined with chemotherapy in people with advanced or metastatic non-squamous non-small cell lung cancer NSCLC who have a KRAS G12C mutation. This Phase IbIII study includes five groups of participants, each receiving different combinations of IBI351 with other treatments, aiming to better understand how well this approach works and how safe it is. The study features five treatment groups one receiving IBI351 alone, and others receiving IBI351 combined with Sintilimab, pemetrexed plus cis-platinum or carboplatin, Cetuximab, or pemetrexed plus cis-platinum or carboplatin again, depending on PD-L1 expression levels. IBI351 is an oral medication designed to inhibit the KRAS G12C mutation. The other drugs are given intravenously at specified doses and schedules, such as every two or three weeks. Participants will be monitored for side effects and treatment effectiveness over 12 to 24 months. Researchers will assess dose limiting toxicities, clinical efficacy, safety indicators, drug levels in the blood, and overall survival. The study involves regular visits for evaluations and treatment, with careful tracking of adverse events and long-term outcomes.

Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation