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 (NCT05091567)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (15 items).
Location: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria for the Induction Phase:
- Presence or history of CNS metastases
- Active or history of autoimmune disease or deficiency
- History of malignancies other than SCLC within 5 years prior to enrollment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Treatment with investigational therapy within 28 days prior to enrollment Inclusion Criteria for the Maintenance Phase:
- ECOG PS of 0 or 1
- Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
- Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade \<=1
- Adequate hematologic and end-organ function Exclusion Criteria for the Maintenance Phase:
- Presence or history of CNS metastases
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (95 Sites)
Showing the first 25 of 95 sites.
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia
- Illinois Cancer Care — Peoria, Illinois
- New England Cancer Specialists — Scarborough, Maine
- Dana Farber Cancer Institute — Boston, Massachusetts
- Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan
- Mercy Research - St. Louis — St Louis, Missouri
- Clinical Research Alliance — Westbury, New York
- The Mark H. Zangmeister Ctr — Columbus, Ohio
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Rhode Island Hospital — Providence, Rhode Island
- Hollings Cancer Center — Charleston, South Carolina
- Greco-Hainesworth Centers for Research — Chattanooga, Tennessee
- West Clinic — Germantown, Tennessee
- Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee
- 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,
- Zentralklinik Bad Berka GmbH — Bad Berka,
- Evang. Lungenklinik Berlin Klinik für Pneumologie — Berlin,
- Helios Klinikum Emil von Behring GmbH — Berlin,
- Klinikum Chemnitz gGmbH — Chemnitz,
- KEM/Evang. Kliniken Essen Mitte gGmbH — Essen,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Small-Cell Lung Cancer
- 7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI) — Columbia, Missouri
- Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial) — St Louis, Missouri
- Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer — Baltimore, Maryland
- A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) — Casa Grande, Arizona
- A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer — Denver, Colorado
Explore by condition: All Small-Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.