Status:
NOT_YET_RECRUITING
A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China
Lead Sponsor:
Guangdong Association of Clinical Trials
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
Brief Summary
This study is a retrospective, multicenter, real-world investigation designed to evaluate the efficacy and safety of IBI-351 in Chinese patients with advanced non-small cell lung cancer (NSCLC) harbor...
Eligibility Criteria
Inclusion
- Voluntarily participate in the study and provide signed informed consent.
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC, classified according to the IASLC 8th edition Lung Cancer TNM Staging System.
- Carry a confirmed KRAS G12C mutation via molecular testing.
- Have received at least one dose of oral IBI-351 treatment between August 2024 and August 2025.
Exclusion
- Histologically or cytologically confirmed mixed NSCLC with a predominant small cell or squamous cell carcinoma component.
- Presence of EGFR sensitizing mutations, ALK rearrangements, ROS1 fusions, or other genomic alterations for which NMPA has approved first-line NSCLC therapies.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT07198620
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,
Guangzhou, Guangdong, China, 510080