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

NCT ID: NCT07198620

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IBI351 treatment

Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Association of Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Qing Zhou, PhD

Role: CONTACT

+86 20 83827812

Facility Contacts

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Qing Zhou, PhD

Role: primary

+86 20 83827812

Other Identifiers

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CTONG2507

Identifier Type: -

Identifier Source: org_study_id

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