A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China
ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGuangdong Association of Clinical Trials
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: IBI351 treatment
Trial outcomes
Primary outcomes
1
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 retrospectivelySecondary outcomes
1
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 retrospectively2
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 retrospectively3
Overall survival
The time from the first administration of IBI351 to death due to any reason
Time frame
At least 12 months retrospectively4
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 retrospectivelySponsors and contacts
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Source ClinicalTrials.gov
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