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Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated ES-SCLC

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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)

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Lung

Study Purpose

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; TrodelvyĀ®; 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 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).

Principal Investigator
Afshin Dowlati MD
Department/Division
Cancer (Thoracic)

Locations

UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: Pro00085679
  • StudyID: GSI1525
  • ClinicalTrials.gov: NCT06801834
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