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 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAtezolizumab and Lurbinectedin

Plus 2 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 9, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?93 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

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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How this study is categorized

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

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

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

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
Clinical Research AllianceWestbury, New York
The Mark H. Zangmeister CtrColumbus, Ohio
Rhode Island HospitalProvidence, Rhode Island
Hollings Cancer CenterCharleston, South Carolina
Greco-Hainesworth Centers for ResearchChattanooga, Tennessee
West ClinicGermantown, Tennessee
Sarah Cannon Research Institute / Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2026. Always confirm current availability with the study team.

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