Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT07198620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'At least 12 months retrospectively', 'description': 'The proportion of patients achieving complete and partial response after treatment, measured according to RECIST v1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Time to treatment discontinuation', 'timeFrame': 'At least 12 months retrospectively', 'description': 'The time from the initiation of IBI351 to the patient discontinuing the medication for any reason'}, {'measure': 'Progression-free survival', 'timeFrame': 'At least 12 months retrospectively', 'description': '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.'}, {'measure': 'Overall survival', 'timeFrame': 'At least 12 months retrospectively', 'description': 'The time from the first administration of IBI351 to death due to any reason'}, {'measure': 'Adverse events', 'timeFrame': 'At least 12 months retrospectively', 'description': 'Assessed by recording treatment-related adverse events and serious adverse events , graded according to the CTCAE version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily participate in the study and provide signed informed consent.\n* Have histologically or cytologically confirmed locally advanced or metastatic NSCLC, classified according to the IASLC 8th edition Lung Cancer TNM Staging System.\n* Carry a confirmed KRAS G12C mutation via molecular testing.\n* Have received at least one dose of oral IBI-351 treatment between August 2024 and August 2025.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed mixed NSCLC with a predominant small cell or squamous cell carcinoma component.\n* Presence of EGFR sensitizing mutations, ALK rearrangements, ROS1 fusions, or other genomic alterations for which NMPA has approved first-line NSCLC therapies.'}, 'identificationModule': {'nctId': 'NCT07198620', 'briefTitle': 'A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Association of Clinical Trials'}, 'officialTitle': 'Efficacy and Safety of IBI351 in Chinese Patients With KRAS G12C-Mutant Advanced NSCLC: A Retrospective Real-World Study', 'orgStudyIdInfo': {'id': 'CTONG2507'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBI351 treatment', 'description': 'Patients with KRAS G12C-Mutant Advanced NSCLC Treated with IBI351'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Qing Zhou, PhD', 'role': 'CONTACT', 'email': 'gzzhouqing@126.com', 'phone': '+86 20 83827812'}], 'facility': "Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qing Zhou, PhD', 'role': 'CONTACT', 'email': 'gzzhouqing@126.com', 'phone': '+86 20 83827812'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Association of Clinical Trials', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}