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Protocol Summary


Protocol No.
PSCI-21-064
Prinicipal Investigator
Ma, Patrick
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
BGB-A317-A1217-302
Title
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.
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center