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.
Study Type
OBSERVATIONAL
Enrollment
600
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,
Guangzhou, Guangdong, China
Objective response rate
The proportion of patients achieving complete and partial response after treatment, measured according to RECIST v1.1 criteria
Time frame: At least 12 months retrospectively
Time to treatment discontinuation
The time from the initiation of IBI351 to the patient discontinuing the medication for any reason
Time frame: At least 12 months retrospectively
Progression-free survival
defined as the time from first dose of IBI351 to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1 criteria.
Time frame: At least 12 months retrospectively
Overall survival
The time from the first administration of IBI351 to death due to any reason
Time frame: At least 12 months retrospectively
Adverse events
Assessed by recording treatment-related adverse events and serious adverse events , graded according to the CTCAE version 5.0
Time frame: At least 12 months retrospectively
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