| Description |
This is a randomized, double-blind, study of IV INCMGA00012 or placebo combined with platinum-based chemotherapy in participants with metastatic nonsquamous or squamous NSCLC who have not previously received systemic therapy for advanced disease and who do not have sensitizing driver mutations or gene rearrangements of EGFR, ALK, BRAF, or ROS1. The primary objectives of the study will be to compare the OS and PFS of the combinations of INCMGA00012 and chemotherapy versus placebo and chemotherapy. The secondary objectives of the study will be to compare ORR and DOR of the combinations of INCMGA00012 and chemotherapy versus placebo and chemotherapy, evaluate the safety and tolerability of the combination of INCMGA00012 and chemotherapy and the combination of placebo and chemotherapy, evaluate the PK of INCMGA00012 375 mg Q3W when administered with chemotherapy. |