Overview
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.
Description
This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with Sintilimab± chemotherapy. There will be four cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Three cohorts (A, C and D) are treated with IBI351+Sintilimab, IBI351+Sintilimab+pemetrexed, or IBI351+Sintilimab+pemetrexed+cis-platinum/carboplatin, respectively, as first-line therapy. Cohort B enrolles subjects who is intolerant or has failed in standard-of care treatment,and is treated with IBI351+Cetuximab.
IBI351 is an orally available small molecule inhibitor of KRAS G12C.
Eligibility
Inclusion Criteria:
- Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
- Unresectable or metastatic disease
- Adequate organ function
Exclusion Criteria:
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
- Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
- Active brain metastases.