NCT07198841

IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation. Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity. Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.

Conditions

• Lung Cancer (Non-Small Cell)

Interventions

Type	Name	Description
DRUG	IBI351 combined with cetuximab β	Subjects will receive treatment with IBI351 plus cetuximab β, consisting of oral IBI351 administered at 600 mg twice daily (BID) either in a fasting or fed state, combined with intravenous infusion of cetuximab β injection dosed at 500 mg/m² (body surface area) every two weeks. Each treatment cycle spans two weeks. Therapy will continue until disease progression, unacceptable toxicity, or meeting other protocol-defined criteria for treatment discontinuation-whichever occurs first. Dose adjustments may be implemented throughout the study based on drug-related toxicities.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-09-30
• Last updated: 2026-03-11

Locations

7 sites across 1 country: China