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

Part of paid clinical trials in Marietta, Georgia.

Sponsor
Hoffmann-La Roche
Study ID
NCT05091567
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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 — DRUG
    Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
  • Carboplatin — DRUG
    Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
  • Etoposide — DRUG
    Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Study Details

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.

Key Dates

Start date
Nov 18, 2021
Status verified
Jun 2026
Primary completion
Jul 29, 2024
Completion
Aug 13, 2026

Study Design

Enrollment
660 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Atezolizumab+Lurbinectedin
    Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
  • Active Comparator: Arm B: Atezolizumab
    Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.

Primary Outcome Measure

Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) [ Time Frame: Up to 26 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalMariettaGeorgia30060-
Illinois Cancer CarePeoriaIllinois61615-
New England Cancer SpecialistsScarboroughMaine04074-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Cancer & Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Mercy Research - St. LouisSt LouisMissouri63141-
Clinical Research AllianceWestburyNew York11590-
The Mark H. Zangmeister CtrColumbusOhio43219-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Rhode Island HospitalProvidenceRhode Island02903-
Hollings Cancer CenterCharlestonSouth Carolina29425-
Greco-Hainesworth Centers for ResearchChattanoogaTennessee37403-
West ClinicGermantownTennessee38138-
Sarah Cannon Research Institute / Tennessee OncologyNashvilleTennessee37203-

Related coverage on Hipa.ai

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By research site
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital· Marietta, GAIllinois Cancer Care· Peoria, ILNew England Cancer Specialists· Scarborough, MEDana Farber Cancer Institute· Boston, MACancer & Hematology Centers of Western Michigan· Grand Rapids, MIMercy Research - St. Louis· St Louis, MO

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