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

NCT07198620 | Not Yet Recruiting

• 1 other identifier: CTONG2507
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The proportion of patients achieving complete and partial response after treatment, measured according to RECIST v1.1 criteria

  At least 12 months retrospectively

Secondary Outcomes (4)

• Time to treatment discontinuation

  At least 12 months retrospectively

• Progression-free survival

  At least 12 months retrospectively

• Overall survival

  At least 12 months retrospectively

• Adverse events

  At least 12 months retrospectively

Study Arms (1)

IBI351 treatment

Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Qing Zhou, PhD

CONTACT

+86 20 83827812; gzzhouqing@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-08

Locations

CN (1)