NCT06801834

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 695 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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).

Conditions

• Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan (SG)	Administered intravenously
DRUG	Topotecan	Administered intravenously
DRUG	Amrubicin (Japan only)	Administered intravenously

Timeline

• Start date: 2025-04-04
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-01-30
• Last updated: 2026-03-19

Locations

205 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study