A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer (NSCLC). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of IBI351 in Chinese Patients With KRAS G12C-Mutant Advanced NSCLC: A Retrospective Real-World Study
Overview
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.
Primary outcome measures
- Objective response rate [Time frame: At least 12 months retrospectively]
Secondary outcome measures (4)
- Time to treatment discontinuation [Time frame: At least 12 months retrospectively]
- Progression-free survival [Time frame: At least 12 months retrospectively]
- Overall survival [Time frame: At least 12 months retrospectively]
- Adverse events [Time frame: At least 12 months retrospectively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy — Guangzhou
Identifiers
NCT: NCT07198620 · CTONG2507