NCT07198620

A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China

Efficacy and Safety of IBI351 in Chinese Patients With KRAS G12C-Mutant Advanced NSCLC: A Retrospective Real-World Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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) harboring a KRAS G12C mutation in a real-world setting. A total of 600 patients with KRAS G12C-mutated advanced NSCLC who received treatment with IBI-351 between August 2024 and August 2025 will be retrospectively enrolled. Descriptive statistical methods will be used to summarize the baseline characteristics, demographic data, and medication profiles of the subjects. Unless otherwise specified, continuous data will be described using counts, means, standard deviations, maximum and minimum values, and medians; categorical data will be summarized using counts and percentages. The incidence of adverse events (AEs) and serious adverse events (SAEs) will be aggregated and presented as the number and percentage of affected subjects, and all AEs will be listed in detail. The primary endpoint is the objective response rate (ORR) as assessed by investigators, and descriptive statistics for ORR will be provided. For the secondary endpoints, progression-free survival (PFS) and overall survival (OS), Kaplan-Meier (K-M) analysis will be performed to estimate median values and corresponding 95% confidence intervals (CIs), and K-M curves will be generated accordingly.

Conditions

• Lung Cancer (NSCLC)

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China