Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-29 @ 1:19 PM
Study NCT ID:
NCT07170995
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'C000707970', 'term': 'tislelizumab'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]', 'timeFrame': 'Approximately 32 months.', 'description': 'PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 \\[RECIST 1.1\\]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)'}, {'measure': 'OS', 'timeFrame': 'Approximately 64 months.', 'description': 'OS was defined as the time from the date of randomization until death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'PFS by the investigator', 'timeFrame': 'Approximately 32 months.', 'description': 'PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 32 months.', 'description': 'ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR).'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Approximately 32 month', 'description': 'DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.'}, {'measure': 'Incidence and Severity of Adverse Events (AEs)', 'timeFrame': 'Approximately 64 months.', 'description': 'Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.'}, {'measure': 'Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)', 'timeFrame': 'Approximately 64 months.', 'description': 'The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms and treatment-related symptoms from conventional chemotherapy and radiotherapy. Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic 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. Voluntary participation and written informed consent.\n2. 18-75 years old, no gender limitation.\n3. Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.\n4. Confirmed tumor PD-L1 status prior to randomization.\n5. Eastern Cooperative Oncology Group (ECOG) score: 0-1\n6. With a life expectancy ≥ 3 months.\n7. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;\n2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;\n3. Previous or co-existing malignancies；\n4. Have Active or prior documented autoimmune or inflammatory disorders;\n5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;\n6. Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.'}, 'identificationModule': {'nctId': 'NCT07170995', 'briefTitle': 'Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SHR-8068-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-8068，adebelizumab and platinum-based chemotherapy', 'interventionNames': ['Drug: SHR-8068，adebelizumab and platinum-based chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tislelizumab, and platinum-based chemotherapy', 'interventionNames': ['Drug: tislelizumab, and platinum-based chemotherapy']}], 'interventions': [{'name': 'SHR-8068，adebelizumab and platinum-based chemotherapy', 'type': 'DRUG', 'description': 'SHR-8068，adebelizumab and platinum-based chemotherapy', 'armGroupLabels': ['SHR-8068，adebelizumab and platinum-based chemotherapy']}, {'name': 'tislelizumab, and platinum-based chemotherapy', 'type': 'DRUG', 'description': 'tislelizumab, and platinum-based chemotherapy', 'armGroupLabels': ['tislelizumab, and platinum-based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinming Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Cancer Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Weixia Li', 'role': 'CONTACT', 'email': 'weixia.li@hengrui.com', 'phone': '+86 021-61053363'}, {'name': 'Yang Wang', 'role': 'CONTACT', 'email': 'yang.wang.yw263@hengrui.com', 'phone': '+86 021-61053363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}