Active Not RecruitingPhase 3NCT05091567

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 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.

Checked against the public recordLast updated Jun 29, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations95
SponsorHoffmann-La Roche
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Atezolizumab; Drug: Lurbinectedin; Drug: Carboplatin; Drug: Etoposide
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria for the Induction Phase: * ECOG PS of 0 or 1 * No prior systemic therapy for ES-SCLC * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC * Histologically or cytologically confirmed ES-SCLC * Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab * Measurable disease, as defined by RECIST v1.1 * Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening 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 * Receiving consolidative chest radiation * Severe infection within 2 weeks prior to randomization into the maintenance * Treatment with therapeutic oral or IV antibiotics at the time of randomization

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalMarietta, Georgia
  • Illinois Cancer CarePeoria, Illinois
  • New England Cancer SpecialistsScarborough, Maine
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan
  • Mercy Research - St. LouisSt Louis, Missouri
  • Clinical Research AllianceWestbury, New York
  • The Mark H. Zangmeister CtrColumbus, Ohio
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • Rhode Island HospitalProvidence, Rhode Island
  • Hollings Cancer CenterCharleston, South Carolina
  • Greco-Hainesworth Centers for ResearchChattanooga, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2026. Always confirm current availability with the study team.

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