Combining IBI351 with chemotherapy for advanced lung cancer with KRAS G12C mutation
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
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 |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Sintilimab, Cetuximab |
| Locations | 1 site (Jilin, Changchun) |
| Trial ID | NCT05504278 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
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 this trial is running
Jilin, Changchun
- Jilin Province Cancer Hospital — Jilin, Changchun, China (Recruiting)
Study contacts
- Study coordinator: Haiyan Zhu
- Email: haiyan.zhu@innoventbio.com
- Phone: 0512-69566088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.