Trial Identifiers
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Scientific Title
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer
Commercial Sponsor
Hoffmann-La Roche
Summary
Eligible participants will be allocated to one of three cohorts depending on their cancer's biomarker status. Within each cohort, participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm.
Cohort A1 is for ALK-Positive participants. In the Cohort A1 Experimental Arm, participants will receive alectinib (600mg) orally twice daily. In Cohort A1 Active Comparator Arm, participants will receive durvalumab (1500mg) intravenously every 4 weeks.
Cohort A2 is for ROS 1-positive participants. In the Cohort A2 Experimental Arm, participants will receive entrectinib (600mg) orally once daily. In Cohort A2 Active Comparator Arm, participants will receive durvalumab (1500mg) intravenously every 4 weeks.
Cohort A3 is for RET fusion-positive participants. In the Cohort A3 Experimental Arm, participants will receive pralsetinib (400mg) orally once daily. In the Cohort A3 Active Comparator arm, participants will receive durvalumab (1500mg) intravenously once every 4 weeks.