Sponsor: Genentech
Sponsor Study ID: GO43104
Study Title: 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
CTO #: 103484
NCT Number: NCT05091567
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lung
Study Objectives: 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.