Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT02815592
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2016-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of BMS-986012 in Combination With Platinum and Etoposide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Germany', 'United States']}, '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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Cycle 1, Day 1 up to approximately 26 months.'}, {'measure': 'Number of participants with serious adverse events (SAEs )', 'timeFrame': 'Date of enrollment up to approximately 26 months.'}, {'measure': 'Discontinuations due to AEs', 'timeFrame': 'Cycle 1, Day 1 up to approximately 26 months.'}, {'measure': 'Number of participants who died due to AEs', 'timeFrame': 'Cycle 1, Day 1 up to approximately 26 months.'}, {'measure': 'Number of participants with laboratory toxicity grade shift from baseline', 'timeFrame': 'Cycle 1, Day 1 up to approximately 26 months.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'From date of first dose or randomization until date of confirmed disease progression, up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration(Cmax)', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose'}, {'measure': 'Time of maximum observed serum concentration(Tmax)', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose'}, {'measure': 'Observed serum concentration at the end of a dosing interval(Ctau)', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose'}, {'measure': 'Area under the concentration-time curve in 1 dosing interval(AUC(TAU))', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose'}, {'measure': 'Characterization of Immunogenicity', 'timeFrame': 'Cycle 1 Day 1 up to 60 days after last dose', 'description': 'Anti-Drug Antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/home', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Male and Females 18 years of age or older\n* Pulmonary SCLC documented by histology or cytology\n* Extensive disease (Stage IV) SCLC\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nExclusion Criteria:\n\n* Prior systemic therapy for lung cancer\n* Symptomatic brain metastases\n* Grade 2 peripheral neuropathy\n* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV\n* Other active malignancies or prior malignancy within 2 years\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT02815592', 'briefTitle': 'Trial of BMS-986012 in Combination With Platinum and Etoposide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA001-044'}, 'secondaryIdInfos': [{'id': '2016-001692-67', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1', 'description': 'BMS-986012/Cisplatin/Etoposide', 'interventionNames': ['Drug: BMS-986012', 'Drug: Cisplatin', 'Drug: Etoposide']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 2', 'description': 'BMS-986012/Carboplatin/Etoposide', 'interventionNames': ['Drug: BMS-986012', 'Drug: Etoposide', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 3A', 'description': 'BMS-986012/Platinum/Etoposide', 'interventionNames': ['Drug: BMS-986012', 'Drug: Etoposide', 'Drug: Platinum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator Arm 3B', 'description': 'Platinum/Etoposide', 'interventionNames': ['Drug: Etoposide', 'Drug: Platinum']}], 'interventions': [{'name': 'BMS-986012', 'type': 'DRUG', 'armGroupLabels': ['Experimental Arm 1', 'Experimental Arm 2', 'Experimental Arm 3A']}, {'name': 'Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Experimental Arm 1']}, {'name': 'Etoposide', 'type': 'DRUG', 'armGroupLabels': ['Active Comparator Arm 3B', 'Experimental Arm 1', 'Experimental Arm 2', 'Experimental Arm 3A']}, {'name': 'Platinum', 'type': 'DRUG', 'armGroupLabels': ['Active Comparator Arm 3B', 'Experimental Arm 3A']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Experimental Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 0004', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda - Madrid', 'country': 'Spain', 'facility': 'Local Institution - 0003'}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Local Institution - 0010', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}