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

Guangdong Association of Clinical Trials

Status: Not yet enrolling

Conditions: Lung Cancer (NSCLC)

Study type: Observational

Funder types: Other

Identifiers

NCT07198620

CTONG2507

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

600 participants in 1 patient group

IBI351 treatment

Description:

Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351