A Phase IIIb, Randomized, Multicenter, Open-label Study to assess the Efficacy of Durvalumab plus Tremelimumab versus Pembrolizumab in Combination with Platinum-Based Chemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Non-Squamous Histology who have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
Objective
Dual Primary Objectives: To assess the efficacy of durvalumab plus tremelimumab plus chemotherapy compared with pembrolizumab plus chemotherapy in terms of OS, in participants with non-squamous histology who have metastatic NSCLC with mutations and/or co-mutations in STK11, KEAP1, or KRAS. To assess the efficacy of durvalumab plus tremelimumab plus chemotherapy compared with pembrolizumab plus chemotherapy in terms of OS, in participants with non-squamous histology who have metastatic NSCLC with STK11 or KEAP1 mutations and/or co-mutations
Secondary Objective: To further assess the efficacy of durvalumab plus tremelimumab plus chemotherapy compared with pembrolizumab plus chemotherapy in terms of OS, PFS, ORR, DoR and TFST, in participants with non-squamous histology who have metastatic NSCLC with mutations and/or co-mutations in STK11, KEAP1, or KRAS.
