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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
Host / recruiting site 1 Amsterdam UMC Enrollment Planned
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.
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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