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NCT Number: NCT07198620

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

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.

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510080, China

Location contact

Qing Zhou, PhD

CONTACT

[email protected]

+86 20 83827812

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Objective response rate

    Time frame: At least 12 months retrospectively

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

Secondary outcomes

  1. Time to treatment discontinuation

    Time frame: At least 12 months retrospectively

    The time from the initiation of IBI351 to the patient discontinuing the medication for any reason

  2. Progression-free survival

    Time frame: At least 12 months retrospectively

    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.

  3. Overall survival

    Time frame: At least 12 months retrospectively

    The time from the first administration of IBI351 to death due to any reason

  4. Adverse events

    Time frame: At least 12 months retrospectively

    Assessed by recording treatment-related adverse events and serious adverse events , graded according to the CTCAE version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Zhou, PhD

CONTACT

[email protected]

+86 20 83827812

Sponsors and collaborators

Lead sponsor

Guangdong Association of Clinical Trials

Other

Registry information

Official study title

Efficacy and Safety of IBI351 in Chinese Patients With KRAS G12C-Mutant Advanced NSCLC: A Retrospective Real-World Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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