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

• Status: Not yet recruiting
• Trial end date: 2027-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Carboplatin; Cetuximab; Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

2. Unresectable or metastatic disease

3. Adequate organ function

Exclusion Criteria:

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications

2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).

3. Active brain metastases.