Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
NCT06801834 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 695
Last updated 2026-05-20
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 overall survival (OS).
Conditions
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Interventions
- DRUG
-
Sacituzumab Govitecan (SG)
Administered intravenously
- DRUG
-
Topotecan
Administered intravenously
- DRUG
-
Amrubicin (Japan only)
Administered intravenously
- DRUG
-
Lurbinectedin (regions/countries where approved and available)
Administered intravenously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-04
- Primary Completion
- 2029-10-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
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
Study Locations
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