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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05091567

Public ClinicalTrials.gov record NCT05091567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 10:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05091567
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
660 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 17, 2021
Primary completion
Jul 28, 2024
Completion
Feb 27, 2028
Last update posted
Sep 8, 2026

2021 – 2028

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital Marietta Georgia 30060
Illinois Cancer Care Peoria Illinois 61615
New England Cancer Specialists Scarborough Maine 04074
Dana Farber Cancer Institute Boston Massachusetts 02215
Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan 49503
Clinical Research Alliance Westbury New York 11590
The Mark H. Zangmeister Ctr Columbus Ohio 43219
Rhode Island Hospital Providence Rhode Island 02903
Hollings Cancer Center Charleston South Carolina 29425
Greco-Hainesworth Centers for Research Chattanooga Tennessee 37403
West Clinic Germantown Tennessee 38138
Sarah Cannon Research Institute / Tennessee Oncology Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05091567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 8, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05091567 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →