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
Running, not enrolling · Phase 3
Conditions studied: Small-Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT05091567
- Run by
- Hoffmann-La Roche
- People needed
- 660
- Starts
- 2021-11-18
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Illinois Cancer Care — Peoria, Illinois, United States
- New England Cancer Specialists — Scarborough, Maine, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
- Mercy Research - St. Louis — St Louis, Missouri, United States
- Clinical Research Alliance — Westbury, New York, United States
- The Mark H. Zangmeister Ctr — Columbus, Ohio, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Hollings Cancer Center — Charleston, South Carolina, United States
- Greco-Hainesworth Centers for Research — Chattanooga, Tennessee, United States
- West Clinic — Germantown, Tennessee, United States
- Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
- Institut Jules Bordet — Anderlecht, Belgium
- Jessa Zkh (Campus Virga Jesse) — Hasselt, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- AZ St Maarten Campus Leopoldstr — Mechelen, Belgium
- CHU UCL Mont-Godinne — Mont-godinne, Belgium
- Vitaz — Sint-Niklaas, Belgium
- Zentralklinik Bad Berka GmbH — Bad Berka, Germany
- Evang. Lungenklinik Berlin Klinik für Pneumologie — Berlin, Germany
- Helios Klinikum Emil von Behring GmbH — Berlin, Germany
- Klinikum Chemnitz gGmbH — Chemnitz, Germany
- KEM/Evang. Kliniken Essen Mitte gGmbH — Essen, Germany
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia, United States
Full record on ClinicalTrials.gov
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