Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT03711305
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2018-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
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': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Overall Survival (OS)', 'timeFrame': 'up to approximately 31 months', 'description': 'Baseline until death from any cause'}], 'secondaryOutcomes': [{'measure': 'Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1', 'timeFrame': 'up to approximately 6 months'}, {'measure': 'Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1', 'timeFrame': 'up to approximately 31 months', 'description': 'Baseline until partial response (PR) or complete response (CR), whichever occurs first'}, {'measure': 'Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1', 'timeFrame': 'up to approximately 31 months', 'description': 'First occurrence of PR or CR until PD or death, whichever occurs first'}, {'measure': 'Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year', 'timeFrame': '6 months, 1 year'}, {'measure': 'Percentage of Participants Alive at 1 Year and 2 Years', 'timeFrame': '1 year, 2 years'}, {'measure': 'Percentage of Participants with Adverse Events Or Serious Adverse Events.', 'timeFrame': 'up to approximately 31 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive-stage Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38582540', 'type': 'DERIVED', 'citation': 'Long Y, Wang H, Xie X, Li J, Xu Y, Zhou Y. Updated cost-effectiveness analysis of adebrelimab plus chemotherapy for extensive-stage small cell lung cancer in China. BMJ Open. 2024 Apr 5;14(4):e077090. doi: 10.1136/bmjopen-2023-077090.'}, {'pmid': '35576956', 'type': 'DERIVED', 'citation': 'Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.', 'detailedDescription': 'Participants will be randomized in a 1:1 ratio to receive either SHR-1316 + carboplatin + etoposide or placebo + carboplatin + etoposide for 4-6 cycles in the induction phase followed by maintenance with SHR-1316 or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18 years and \\<= 75 years\n* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \\[VALG\\] staging system)\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* No prior systemic treatment or immune checkpoint inhibitor treatment for ES-SCLC\n* At least 6 months treatment-free period since last chemo/radiotherapy with curative intent for limited-stage SCLC\n* Measurable disease, as defined by RECIST v1.1\n* Adequate hematologic and end organ function\n* Patients must submit a pre-treatment tumor tissue sample during the study.\n* Signed inform consent form\n\nExclusion Criteria:• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation\n\n* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization\n* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia\n* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome\n* History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease\n* Prior treatment with immune checkpoint blockade therapies\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.\n* Significant cardiovascular disease\n* Prior allogeneic bone marrow transplantation or solid organ transplant\n* Treatment with systemic immunosuppressive medications within 2 weeks prior to randomization\n* History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator"}, 'identificationModule': {'nctId': 'NCT03711305', 'briefTitle': 'Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Randomized, Double-blinded, Placebo Controlled, Multicenter, Phase III Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)', 'orgStudyIdInfo': {'id': 'SHR-1316-III-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1316 + carboplatin + etoposide', 'description': 'Participants will receive SHR-1316 intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6). Thereafter, participants will receive maintenance (after induction phase) SHR-1316 until persistent radiographic PD, intolerable toxicity or withdrawal of consent.', 'interventionNames': ['Drug: SHR-1316', 'Drug: Carboplatin', 'Drug: Etoposide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + carboplatin + etoposide', 'description': 'Participants will receive placebo intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6). Thereafter, participants will receive maintenance (after induction phase) placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Placebo']}], 'interventions': [{'name': 'SHR-1316', 'type': 'DRUG', 'description': 'SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.', 'armGroupLabels': ['SHR-1316 + carboplatin + etoposide']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).', 'armGroupLabels': ['Placebo + carboplatin + etoposide', 'SHR-1316 + carboplatin + etoposide']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).', 'armGroupLabels': ['Placebo + carboplatin + etoposide', 'SHR-1316 + carboplatin + etoposide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.', 'armGroupLabels': ['Placebo + carboplatin + etoposide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Jilin', 'state': 'Changchun', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}], 'overallOfficials': [{'name': 'Wei Shi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jiangsu HengRui Medicine Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}