Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-08 @ 11:04 AM
Study NCT ID:
NCT06434103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': '21 days after the first dose'}, {'measure': 'ORR based on RECIST v1.1 assessment.', 'timeFrame': 'All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Adverse event', 'timeFrame': 'All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years'}, {'measure': 'DCR based on RECIST v1.1 assessment', 'timeFrame': 'All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;\n2. Aged 18-75 at the time of signing the informed consent;\n3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;\n4. At least one measurable lesion consistent with RECIST v1.1;\n5. ECOG PS score: 0-1;\n6. The organ function level is good;\n\nExclusion Criteria:\n\n1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;\n2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;\n3. Previous or co-existing malignant neoplasms;\n4. The presence of any active or known autoimmune disease;\n5. Have clinical symptoms or diseases of the heart that are not well controlled;\n6. People with past or current interstitial pneumonia/interstitial lung disease;\n7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;\n8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;'}, 'identificationModule': {'nctId': 'NCT06434103', 'briefTitle': 'Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC', 'orgStudyIdInfo': {'id': 'SHR-A1921-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin', 'interventionNames': ['Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin']}], 'interventions': [{'name': 'SHR-A1921；Adebrelimab；SHR-8068；carboplatin', 'type': 'DRUG', 'description': 'SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.', 'armGroupLabels': ['SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mengbo Zhao', 'role': 'CONTACT', 'email': 'mengbo.zhao@hengrui.com', 'phone': '0518-82342973'}, {'name': 'Ze Zhang', 'role': 'CONTACT', 'email': 'ze.zhang.zz1@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}