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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
Lung Cancer (Non-Small Cell)
Interventions
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.

Trial Locations (1)

510080

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,, Guangzhou

All Listed Sponsors
collaborator

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

collaborator

Mabpharm Limitied

UNKNOWN

lead

Guangdong Association of Clinical Trials

OTHER

NCT07198841 - IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation | Biotech Hunter | Biotech Hunter