Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Combining IBI351 with chemotherapy for advanced lung cancer with KRAS G12C mutation

Official title: An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Run by Innovent Biologics (Suzhou) Co. Ltd. · NCT05504278 · Data updated 2026-11-12

This study is testing if a new drug called IBI351 can work better with chemotherapy for people with advanced lung cancer that has a specific KRAS G12C mutation.

More Advanced Non-Small Cell Lung Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment144 (estimated)
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Industry-sponsored
Drugs / interventionschemotherapy, Sintilimab, Cetuximab
Locations1 site (Jilin City, Changchun)
StatusRecruiting
StartedSeptember 20, 2022
Main results expectedMay 31, 2025
Study endsJuly 31, 2027
Registry record updatedJanuary 27, 2025
Trial IDNCT05504278 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with unresectable or metastatic non-squamous NSCLC who have a confirmed KRAS G12C mutation and have not undergone prior systemic therapy.

Probably not a fit

Patients with active brain metastases or those who have previously received treatment targeting the KRAS G12C mutation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib/III study evaluates the efficacy and safety of IBI351, a small molecule inhibitor, in combination with various chemotherapy regimens for patients with advanced non-squamous non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The study includes five treatment cohorts, each receiving different combinations of IBI351 with chemotherapy agents such as pemetrexed, carboplatin, and Cetuximab. Participants must have unresectable or metastatic disease and have not previously received systemic antitumor therapy for their condition.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced lung cancer that has limited treatment alternatives.

How similar studies have gone: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
2. Unresectable or metastatic disease
3. Adequate organ function
4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

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.

Where it's running

  • Jilin Province Cancer Hospital
    Jilin City, Changchun, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.