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NCT05091567 · ClinicalTrials.gov registry record · Phase 3
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
A Phase 3 study of Small-cell Lung Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT05091567 is a Phase 3 study of Small-cell Lung Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 660 participants, above the 224-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT05091567, a Phase 3 study of Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Atezolizumab
- DRUG Etoposide
- DRUG Lurbinectedin
Study Locations (20)
Other
- Institut Jules Bordet - Anderlecht
- Jessa Zkh (Campus Virga Jesse) - Hasselt
- UZ Leuven Gasthuisberg - Leuven
- AZ St Maarten Campus Leopoldstr - Mechelen
- CHU UCL Mont-Godinne - Mont-godinne
- Vitaz - Sint-Niklaas
Tennessee
- Greco-Hainesworth Centers for Research - Chattanooga
- West Clinic - Germantown
- Sarah Cannon Research Institute / Tennessee Oncology - Nashville
Georgia
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital - Marietta
Illinois
- Illinois Cancer Care - Peoria
Maine
- New England Cancer Specialists - Scarborough
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- Cancer & Hematology Centers of Western Michigan - Grand Rapids
Missouri
- Mercy Research - St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2026-08-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05091567
The ClinicalTrials.gov registry entry for NCT05091567 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 224-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (195% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT05091567 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Tennessee, Georgia.
Frequently Asked Questions
What is clinical trial NCT05091567 about?
NCT05091567 is a clinical study titled "A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer". Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with...
What is the current status of trial NCT05091567?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2021-11-18. Estimated completion is 2026-08-13.
What conditions does trial NCT05091567 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT05091567?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT05091567?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05091567 being conducted?
This trial has 20 study locations across Georgia, Illinois, Maine, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.