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Clinical Trials in South Korea / NCT05091567
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2021-11-18
Last updated
2026-09-09

Condition(s) studied

Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

Atezolizumab →Lurbinectedin →Carboplatin →Etoposide →

Atezolizumab: Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.

Lurbinectedin: Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.

Carboplatin: Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Etoposide: Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) — Up to 26 months
    PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
  • Randomized Phase: Overall Survival (OS) — Up to 26 months
    OS was defined as the time from randomization to the date of death from any cause.

Trial sites (93)

FacilityCityRegionStatus
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
Clinical Research Alliance Westbury New York
The Mark H. Zangmeister Ctr Columbus Ohio
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 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
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH Georgsmarienhütte Germany
LungenClinic Großhansdorf GmbH Großhansdorf Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH Halle Germany
Fachklinik für Lungenerkrankungen Immenhausen Germany
Universitätsklinikum Schleswig-Holstein Lübeck Germany
Asklepios Klinik Gauting München-Gauting Germany
Sotiria Thoracic Diseases Hospital of Athens Athens Greece
Errikos Dynan Hospital Athens Greece
University Hospital of Larissa Larissa Greece
Euromedical General Clinic of Thessaloniki Thessaloniki Greece
Ag. Loukas Hospital Thessaloniki Greece
Diavalkaniko Hospital Thessaloniki Greece
Orszagos Koranyi Pulmonologiai Intezet Budapest Hungary
Pécsi Tudományegyetem Pécs Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. Szolnok Hungary
Tudogyogyintezet Torokbalint Törökbálint Hungary
AUSL della Romagna Ravenna Emilia-Romagna

+ 53 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Hoffmann-La Roche trials in South Korea

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Other trials for the same condition

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab Active, not recruiting
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy Active, not recruiting
Study of AZD2811 + Durvalumab in ES-SCLC Active, not recruiting
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05091567 on ClinicalTrials.gov ↗ ← All trials in South Korea