A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
Trial Parameters
Brief Summary
The purpose of the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically documented Stage IV non-squamous NSCLC not amenable to curative surgery or radiation. * Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed. * Participants must have tumors that lack activating epidermal growth factor receptor mutations and ALK fusions. * No prior chemotherapy or any other systemic therapy for metastatic NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred \> 6 months from end of last therapy. * No prior exposure to immune-mediated therapy excluding therapeutic anti-cancer vaccines, within 6 months of randomization. * WHO/ECOG performance status of 0 or 1 at enrollment and randomization. * Minimum life expectancy ≥ 12 weeks at randomization. * At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at