Studieoverzicht

Study name: EVOKE_GU-US-600-6165: A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Histology	SCLC
Tumor stage	Stage III - IV
NCT Id	NCT06801834
Host / recruiting site 1	Amsterdam UMC	Enrollment	Recruiting
Host / recruiting site 2	MUMC+	Enrollment	Recruiting
Host / recruiting site 3	St. Antonius Ziekenhuis	Enrollment	Recruiting
Host / recruiting site 4	Frisius MC locatie Leeuwarden	Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	Open Label Randomized Parallel Assignment
Intervention	Experimental: Treatment Group A: Sacituzumab Govitecan (SG) A. 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. Experimental: Treatment Group B: Topotecan B. 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. Participants will receive study drug until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Key outcome parameters	Objective Response Rate (ORR) Overall Survival (OS)
Key inclusion criteria	Histologically confirmed diagnosis of SCLC. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria. 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. NOTE: Other protocol defined Inclusion criteria may apply. Note: Graag een MRI-hersenen maken vóór verwijzing, dit om hersenmetastasen uit te sluiten en een vlotte start in de studie mogelijk te maken.
Key exclusion criteria	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). Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. 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. NOTE: Other protocol defined Exclusion criteria may apply.
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