Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 11:04 AM
Study NCT ID:
NCT06610734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-24
First Post:
2024-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 202}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-09-14', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months', 'description': 'Refers to the time from the start of randomization until tumor progression or death from any cause, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of randomization to the time when the subject died from any cause, up to approximately 24 months', 'description': 'Refers to the time from the start of randomization until death from any cause.'}, {'measure': 'Disease control rate', 'timeFrame': 'Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months', 'description': 'Proportion of all randomised subjects whose best overall response (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria.'}, {'measure': 'overall response rate', 'timeFrame': 'Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks, up to approximately 24 months', 'description': 'Refers to the proportion of patients who have achieved a pre-defined tumor volume reduction (CR/PR) and maintained the minimum time frame required by the accepted response evaluation criteria (such as solid tumor RECIST Version 1.1).'}, {'measure': 'Duration of response', 'timeFrame': 'Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months', 'description': 'Defined as the period from the date the tumor remission was first recorded to the date the disease progression was first recorded or the date of death from any cause.'}, {'measure': 'Post-progression survival', 'timeFrame': 'From date of progression to the time when the subject died from any cause, up to approximately 24 months', 'description': 'From date of progression to the time when the subject died from any cause'}, {'measure': 'adverse events', 'timeFrame': 'Baseline up to approximately 36 months', 'description': 'The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)'}, {'measure': 'Serious adverse events', 'timeFrame': 'Baseline up to approximately 36 months', 'description': 'The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCLC', 'Adebrelimab', 'LDRT'], 'conditions': ['Small Cell Lung Cancer Extensive Stage']}, 'descriptionModule': {'briefSummary': 'A multicenter, open-label, phase Ⅲ randomized controlled trial evaluating the efficacy and safety of adebrelimab in combination with chemotherapy and low-dose radiotherapy (LDRT) as first-line treatment for extensive-stage small cell lung cancer (SCLC)', 'detailedDescription': 'A multicenter, open-label, phase III randomized controlled trial evaluating the efficacy andsafety of adbelizumab in combination with chemotherapy and low-dose radiotherapy (LDRT) as a first-line treatment for extensive-stage small cell lung cancer (SCLC). At least 202 participants will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 18 to 75 years, regardless of gender;\n* ECOG Performance Status (PS) score of 0-1;\n* Expected survival duration of no less than 8 weeks;\n* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);\n* Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.\n\nExclusion Criteria:\n\n* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;\n* Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);\n* Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;\n* Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;\n* History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;\n* Any previous T-cell co-stimulation or immune checkpoint therapies administered;\n* Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\\"'}, 'identificationModule': {'nctId': 'NCT06610734', 'briefTitle': 'Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'A Multicenter, Open-label, Phase Ⅲ Randomized Controlled Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC', 'orgStudyIdInfo': {'id': 'SKY'}, 'secondaryIdInfos': [{'id': '2024 Review (No. 1573)', 'type': 'OTHER', 'domain': 'Biomedical Ethics Review Committee of West China Hospital of Sichuan University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Adebrelimab combined with chemotherapy synchronous LDRT', 'interventionNames': ['Drug: Adebrelimab', 'Drug: Chemotherapy', 'Radiation: low dose radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Adebrelimab combined with chemotherapy', 'interventionNames': ['Drug: Adebrelimab', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Adebrelimab', 'type': 'DRUG', 'otherNames': ['immunotherapy', 'Programmed death ligand 1 inhibitor'], 'description': 'Adebrelimab combined with chemotherapy synchronous LDRT', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'low dose radiotherapy', 'type': 'RADIATION', 'description': 'low dose radiotherapy', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'You Lu', 'role': 'CONTACT', 'email': 'radyoulu@hotmail.com', 'phone': '02885424619'}, {'name': 'Zhuoran Yao, M.D.', 'role': 'CONTACT', 'email': 'yaozhuoran@outlook.com'}], 'overallOfficials': [{'name': 'You Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After the study is completed.', 'ipdSharing': 'YES', 'description': 'The survival data of individual participant will be shared after the research is completed.', 'accessCriteria': 'Other Medical Professionals with permission from Principle Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Shengdi Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Thoracic Cancer Ward', 'investigatorFullName': 'You Lu', 'investigatorAffiliation': 'Sichuan University'}}}}