This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with dose limiting toxicity — 12 months Number of participants with dose limiting toxicity in the dose escalation period
Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents — 24 months Objective response rate per RECIST v1.1
Safety indicators during the introduction phase for IBI351 combination treatment : — 24 months Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram
Trial sites (1)
Facility
City
Region
Status
Jilin Province Cancer Hospital
Jilin City
Changchun
Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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