At a glance
ClinicalIndex Comparison Record- ✓ECOG performance status 0 or 1
- ✓Histologically or cytologically confirmed extensive-stage small-cell lung cancer
- ✓No prior systemic therapy for ES-SCLC
- ✓If prior chemo/radiotherapy for limited-stage SCLC, must be treatment-free for at least 6 months
- ✕Presence or history of CNS metastases
- ✕Active or prior autoimmune disease or immunodeficiency
- ✕Malignancy other than SCLC within 5 years prior to enrollment
- ✕Prior checkpoint inhibitor therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1), CD137 agonists, lurbinectedin, or trabectedin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Atezolizumab, Lurbinectedin, and 2 other interventions for Small-Cell Lung Cancer. Active but no longer recruiting, targeting 660 participants across 95 sites in 13 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
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.
Interventions
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 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.