RecruitingPhase 2NCT07198841

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

Sponsor

Guangdong Association of Clinical Trials

Enrollment

48 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer (Non-Small Cell)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — IBI351 and cetuximab — for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C. This mutation is found in a subset of lung cancers and makes the tumor harder to treat with standard therapies. **You may be eligible if...** - You are 18–75 years old with confirmed advanced or metastatic NSCLC - Your tumor has been confirmed to have a KRAS G12C mutation - You have not previously received any systemic cancer treatment for advanced disease - You are in good health (ECOG score 0–1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have received prior systemic treatment for this cancer - Your cancer has a different genetic driver mutation - You are allergic to either study drug - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI351 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.

Locations(7)

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

Guangzhou, Guangdong, China

Chinese PLA General Hospital

Beijing, China

The First People's Hospital of Foshan

Foshan, China

The first affiliated hospital of nanchang university

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

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NCT07198841

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