Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 9:18 AM
Study NCT ID:
NCT06801834
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608132', 'term': 'sacituzumab govitecan'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C055866', 'term': 'amrubicin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 695}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 4.5 years', 'description': 'ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 4.5 years', 'description': 'OS is defined as length of time from randomization until the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 4.5 years', 'description': 'PFS is defined as the time from date of randomization until disease progression as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 4.5 years', 'description': 'DOR is defined as is measured from the time of first response (CR or PR) as assessed by BICR according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first'}, {'measure': 'Time to First Deterioration in Shortness of Breath Domain', 'timeFrame': 'Up to 4.5 years', 'description': 'Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.'}, {'measure': 'Time to First Deterioration in Physical Functioning Domain', 'timeFrame': 'Up to 4.5 years', 'description': 'Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death.'}, {'measure': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose date up to 4.5 years', 'description': 'TEAE is defined as any AEs occurred during the treatment-emergent period. The treatment-emergent period is defined as the time period from the first dose of study treatment to the earlier of 30 days following the last dose of study treatment or the initiation of subsequent anticancer therapy.'}, {'measure': 'Percentage of Participants Experiencing Clinical Laboratory abnormalities', 'timeFrame': 'First dose date up to 4.5 years', 'description': 'Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive Stage Small Cell Lung Cancer (ES-SCLC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06801834', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).\n\nThe primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCLC.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.\n* Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.\n\nKey Exclusion Criteria:\n\n* Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \\< 30 days (independent of the immunotherapy maintenance).\n* Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.\n* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06801834', 'acronym': 'EVOKE-SCLC-04', 'briefTitle': 'Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'orgStudyIdInfo': {'id': 'GS-US-600-6165'}, 'secondaryIdInfos': [{'id': '2024-515884-69', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A: SG', 'description': 'Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.', 'interventionNames': ['Drug: Sacituzumab Govitecan (SG)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B: Topotecan or Amrubicin (Japan only)', 'description': 'Participants assigned to treatment group B will receive Topotecan 1.5 mg/m\\^2 daily on Days 1 to 5 of a 21-day cycle.\n\nJapan participants assigned to treatment group B will have the option to receive Topotecan 1.5 mg/m\\^2 daily on Days 1 to 5 of a 21-day cycle, or Amrubicin 40 mg/m\\^2 daily on Days 1 to 3 of a 21-day cycle.\n\nParticipants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.', 'interventionNames': ['Drug: Topotecan', 'Drug: Amrubicin (Japan only)']}], 'interventions': [{'name': 'Sacituzumab Govitecan (SG)', 'type': 'DRUG', 'otherNames': ['Trodelvy®', 'GS-0132', 'IMMU 132'], 'description': 'Administered intravenously', 'armGroupLabels': ['Treatment Group A: SG']}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Treatment Group B: Topotecan or Amrubicin (Japan only)']}, {'name': 'Amrubicin (Japan only)', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Treatment Group B: Topotecan or Amrubicin (Japan only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Los Angeles Cancer Network', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hope and Healing Cancer Services', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 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