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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Sintilimab, Cetuximab |
| Locations | 1 site (Jilin City, Changchun) |
| Status | Recruiting |
| Started | September 20, 2022 |
| Main results expected | May 31, 2025 |
| Study ends | July 31, 2027 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT05504278 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
- Study coordinator: Haiyan Zhu
- Email: haiyan.zhu@innoventbio.com
- Phone: 0512-69566088
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.