Actively Recruiting
Efficacy and Safety of IBI351 with Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-01-27
144
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of IBI351 combined with chemotherapy in people with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation. This Phase Ib/III study includes five groups of participants, each receiving different combinations of IBI351 with other treatments, aiming to better understand how well this approach works and how safe it is. The study features five treatment groups: one receiving IBI351 alone, and others receiving IBI351 combined with Sintilimab, pemetrexed plus cis-platinum or carboplatin, Cetuximab, or pemetrexed plus cis-platinum or carboplatin again, depending on PD-L1 expression levels. IBI351 is an oral medication designed to inhibit the KRAS G12C mutation. The other drugs are given intravenously at specified doses and schedules, such as every two or three weeks. Participants will be monitored for side effects and treatment effectiveness over 12 to 24 months. Researchers will assess dose limiting toxicities, clinical efficacy, safety indicators, drug levels in the blood, and overall survival. The study involves regular visits for evaluations and treatment, with careful tracking of adverse events and long-term outcomes.
CONDITIONS
Brief Title
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of non-squamous NSCLC with KRAS G12C mutation
- Unresectable or metastatic disease
- Adequate organ function
- No previous systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC
You will not qualify if you...
- History of intestinal disease, major gastric surgery, or inability to swallow oral medications
- Prior therapy targeting KRAS G12C mutation (e.g., AMG 510)
- Active brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive IBI351 alone or in combination with chemotherapy and/or other drugs as per their assigned cohort.
Regular visits according to treatment cycles over 24 months
Duration - Up to 24 months
Participants are monitored for safety and overall survival after treatment ends.
Visits scheduled for safety and survival assessments over 24 months
Trial Site Locations
Total: 1 location
1
Jilin Province Cancer Hospital
Jilin City, Changchun, China
Actively Recruiting
Research Team
H
Haiyan Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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