A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer. AdvanTIG-302
Objective
Primary: To compare progression-free survival (PFS) between Arm A (BGB-A1217 in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the Intent-to-Treat (ITT) Analysis Set as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). To compare overall survival (OS) between Arm A (BGB-A1217 in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set
Secondary: To compare PFS between Arm A (BGB-A1217 in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set as assessed by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. To compare the overall response rate (ORR) and duration of response (DOR) between Arm A (BGB-A1217 in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set as assessed by investigators according to RECIST v1.1. To compare health-related quality of life (HRQoL) and time to deterioration (TTD) between Arm A (BGB-A1217 in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the ITT Analysis Set. To further investigate the safety and tolerability of BGB-A1217 in combination with tislelizumab.
