American Oncology Network | Hematology Oncology Clinic
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About
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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Inclusion and exclusion criteria
Inclusion Criteria for the Induction Phase:
Exclusion Criteria for the Induction Phase:
Inclusion Criteria for the Maintenance Phase:
Exclusion Criteria for the Maintenance Phase:
Primary purpose
Allocation
Interventional model
Masking
690 participants in 2 patient groups
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Central trial contact
Reference Study ID Number: GO43104 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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