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Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Study acronym: EVOKE-SCLC-04
StatusRecruiting
PhasePhase 3
Started2025-04-04
View on ClinicalTrials.gov ↗

Amendment history

2026-08-10
Study Status, Contacts/Locations v18
Study sites218→220
2026-07-15
Study Status, Contacts/Locations v17
Study sites218 entries, revised
MaineHealthMaine Health Cancer Care OptumCareOptum Care Cancer Care
2026-06-23
Study Status, Contacts/Locations v16
Trial sites expanded: 210 → 218 locations
2026-05-18
Study Status, Contacts/Locations v15
Trial sites expanded: 205 → 210 locations
2026-04-23
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v14
Primary endpoint(s) modified2 to 1 entries
WasObjective Response Rate (ORR), Overall Survival (OS)
NowOverall Survival (OS)
InterventionsAmrubicin (Japan only) (Drug), Sacituzumab Govitecan (SG) (Drug), Topotecan (Drug)→Amrubicin (Japan only) (Drug), Lurbinectedin (regions/countries where approved and available) (Drug), Sacituzumab Govitecan (SG) (Drug)…
Eligibility criteria+1,397 characters
[...] nd PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC. Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment. If the investigator believes a participant ma [...] Key Exclusion Criteria: Chemotherapy-free interval (CTFI) ti [...] n derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy. UntreatedHave carcinomatous meningiti [...] [...]
Secondary endpoints6 to 7 entries
Objective Response Rate (ORR)
Show 13 earlier versions
2026-03-17
Study Status, Contacts/Locations v13
Study sites204→205
2026-02-19
Study Status, Contacts/Locations v12
Study sites196→204
2026-01-22
Study Status, Contacts/Locations v11
Study sites147→196
2025-11-21
Study Status, Contacts/Locations v10
Study sites131→147
2025-10-23
Study Status, Contacts/Locations v9
Study sites103→131
2025-09-23
Study Status, Contacts/Locations v8
Study sites102→103
2025-09-02
Study Status, Contacts/Locations v7
Study sites70→102
2025-08-08
Study Status, Contacts/Locations v6
Study sites61→70
2025-08-04
Study Status, Contacts/Locations v5
Study sites17→61
2025-06-20
Study Status, Contacts/Locations v4
Study sites5→17
2025-05-06
Study Status, Contacts/Locations v3
Start dateestimated 2025-04→confirmed 2025-04-04
Study sites4→5
2025-04-07
Study Status, Contacts/Locations v2
Study sites1→4
2025-03-12
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
InterventionsSacituzumab Govitecan (SG) (Drug), Topotecan (Drug)→Amrubicin (Japan only) (Drug), Sacituzumab Govitecan (SG) (Drug), Topotecan (Drug)
2025-01-24
Original filing
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). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
Trial Details
NCT Number NCT06801834
Lead Sponsor Gilead Sciences
Conditions Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Enrollment 695 participants
Start Date 2025-04-04
Primary Completion 2029-10 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-12