Viewing Study NCT05353257


Ignite Creation Date: 2025-12-24 @ 6:46 PM
Ignite Modification Date: 2025-12-25 @ 4:18 PM
Study NCT ID: NCT05353257
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-01-28
First Post: 2022-04-25
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'C075609', 'term': 'PE regimen'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival(OS', 'timeFrame': 'up to 36 months', 'description': 'the time from randomization to death due to any cause'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'up to approximately 24months', 'description': 'PFS, assessed by the investigator as per RECIST v1.1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Limited-Stage Small Cell Lung Cancer', 'Serplulimab'], 'conditions': ['Limited-Stage Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'detailedDescription': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\n\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged ≥18 years when signing the ICF.\n2. Histologically diagnosed with SCLC.\n3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\n4. Major organs are functioning well.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC.\n2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.\n3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.\n4. Patients with other active malignancies within 5 years or at the same time.\n5. Subjects with known history of severe allergy to any monoclonal antibody.\n6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.\n7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.'}, 'identificationModule': {'nctId': 'NCT05353257', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'HLX10-020-SCLC302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy', 'description': 'Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.', 'interventionNames': ['Drug: HLX10', 'Drug: carboplatin/cisplatin-etoposide', 'Radiation: Thoracic radiotherapy', 'Radiation: Prophylactic Cranial Irradiation (PCI)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + carboplatin/cisplatin-etoposide + radiotherapy', 'description': 'Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.', 'interventionNames': ['Drug: carboplatin/cisplatin-etoposide', 'Radiation: Thoracic radiotherapy', 'Drug: Placebo', 'Radiation: Prophylactic Cranial Irradiation (PCI)']}], 'interventions': [{'name': 'HLX10', 'type': 'DRUG', 'otherNames': ['Serplulimab'], 'description': 'Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.\n\n300mg Q3W', 'armGroupLabels': ['Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy']}, {'name': 'carboplatin/cisplatin-etoposide', 'type': 'DRUG', 'description': "Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.\n\nCisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.", 'armGroupLabels': ['Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy', 'placebo + carboplatin/cisplatin-etoposide + radiotherapy']}, {'name': 'Thoracic radiotherapy', 'type': 'RADIATION', 'description': 'Standard Thoracic Radiotherapy', 'armGroupLabels': ['Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy', 'placebo + carboplatin/cisplatin-etoposide + radiotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Q3W', 'armGroupLabels': ['placebo + carboplatin/cisplatin-etoposide + radiotherapy']}, {'name': 'Prophylactic Cranial Irradiation (PCI)', 'type': 'RADIATION', 'description': 'PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.', 'armGroupLabels': ['Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy', 'placebo + carboplatin/cisplatin-etoposide + radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'OPN-Glendale', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'OPN-Los Alamitos', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90034', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92373', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Emad Ibrahim, MD, Inc', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lutheran Medical Center - Cancer Centers of Colorado', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology & Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '32257', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Specialists of North Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid Florida Hematology and Oncology Center', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Napa Research', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Mediacal Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pontchartrain Cancer Center', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55425', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Health', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '11373', 'city': 'Elmhurst', 'state': 'New York', 'country': 'United States', 'facility': 'New York City Health+HospitalsCorporation Elmhurst Hospital Center', 'geoPoint': {'lat': 40.73649, 'lon': -73.87791}}, {'zip': '11040', 'city': 'Queens', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.68149, 'lon': -73.83652}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Mercy Hospital', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Tricounty Hematology and Oncology Associates', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'zip': '97229', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Millennium 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'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Klinikum Klagenfurt am Wörthersee', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '1210', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1210', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '233099', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Chest Hospital', 'geoPoint': {'lat': 31.86389, 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'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangdong Pharmaceutical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510030', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '541100', 'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guilin Medical University', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Medical University Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangzhou', 'country': 'China', 'facility': 'Gungzhouyikedaxuefushuzhongliuyiyuan', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '061019', 'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': "Cangzhou People's Hospital", 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'zip': '063001', 'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': "Tangshan People's Hospital", 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '154007', 'city': 'Jiamusi', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Jiamusi Cancer Hospital', 'geoPoint': {'lat': 46.79711, 'lon': 130.31118}}, {'zip': '471000', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '453100', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '999077', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Hong Kong United Oncology Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'TaiHe Hospital Affiliated Hospital of Hubei University of Medicine', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan hospital of wuhan university', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei 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'China', 'facility': "Northern Jiangsu people's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '341001', 'city': 'Ganzhou', 'state': 'Jiangxi', 'country': 'China', 'facility': 'First Affiliated Hospital of Gannan Medical University', 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'zip': '341005', 'city': 'Ganzhou', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Ganzhou Cancer Hospital', 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 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