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NCT06801834 · ClinicalTrials.gov registry record · Phase 3
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
A Phase 3 study of Extensive Stage Small Cell Lung Cancer (ES-SCLC), sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 695
- Enrollment target
- 20
- Study locations
NCT06801834: Recruiting Phase 3 study of Extensive Stage Small Cell Lung Cancer (ES-SCLC), sponsored by Gilead Sciences.
NCT06801834 is a Phase 3 study of Extensive Stage Small Cell Lung Cancer (ES-SCLC) that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 695 participants, above the 89-participant average among 3 other Extensive Stage Small Cell Lung Cancer (ES-SCLC) trials with a reported enrollment target (681% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06801834, a Phase 3 study of Extensive Stage Small Cell Lung Cancer (ES-SCLC), is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 695 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
OS is defined as length of time from randomization until the date of death from any cause.
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG Sacituzumab Govitecan (SG)
- DRUG Amrubicin (Japan only)
Study Locations (20)
Texas
- Hendrick Health System - Abilene
- MD Anderson Cancer Center - Houston
- Texas Oncology - San Antonio - New Braunfels
- The University of Texas Health Science Center at Tyler - Tyler
Illinois
- Hope and Healing Cancer Services - Hinsdale
- Southern Illinois University School of Medicine - Springfield
- Springfield Clinic - Springfield
Indiana
- Parkview Research Center - Fort Wayne
- IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie - Muncie
Kentucky
- Northwest Cancer Centers - Dyer
- St. Claire Regional Medical Ce - Morehead
Ohio
- University Hospitals Seidman Cancer Center - Sandusky
- Taylor Cancer Research Foundation - Toledo
Other
- Hospital Britanico de Buenos Aires - Buenos Aires
- Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires) - Buenos Aires
California
- Los Angeles Cancer Network - Anaheim
Florida
- Boca Raton Regional - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 695 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2029-10 |
| Phase | Phase 3 |
What NCT06801834 shows while recruiting
NCT06801834 is an interventional study that assigns participants to a tested intervention. The registered 695 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 3 other Extensive Stage Small Cell Lung Cancer (ES-SCLC) trials with a reported enrollment target (681% higher).
The record links to 1 condition, with Extensive Stage Small Cell Lung Cancer (ES-SCLC) appearing as the primary indexed condition, and to 3 interventions - of which Topotecan is the first listed.
NCT06801834 names 20 study sites across 11 states, led by Texas, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT06801834 about?
NCT06801834 is a clinical study titled "Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer". 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...
What is the current status of trial NCT06801834?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 695 participants. The study started on 2025-04-04. Estimated completion is 2029-10.
What conditions does trial NCT06801834 study?
This clinical trial studies the following conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC).
What interventions are being tested in trial NCT06801834?
The interventions under investigation include: Topotecan (DRUG), Sacituzumab Govitecan (SG) (DRUG), Amrubicin (Japan only) (DRUG).
Who is sponsoring clinical trial NCT06801834?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06801834 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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