A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER
A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER
This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .
Inclusion Criteria:
Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable non small cell lung cancer (NSCLC).
Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
Provision of fresh or archival tumor tissue or discussion with Sponsor.
Adequate hematologic and end-organ function.
Exclusion Criteria:
Bengbu Shi, 233004, China
Changsha, 410013, China
Changsha-shi, 410013, China
Shanghai Shi, 200030, China
Shapingbaqu, 400030, China
Wuhan, 430022, China
Wuhan, 430030, China
Rio Patras, 26500, Greece
Catania, 95123, Italy
Habikino-shi, 583-8588, Japan
Hirakata-shi, 573-1191, Japan
Matsusaka-shi, 515-8544, Japan
Guimarães, 4835-044, Portugal
Saint Petersburg, 197758, Russia
Saint Petersburg, 197758, Russia
Majadahonda, Madrid, 28222, Spain
Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan
Birmingham, B15 2TH, United Kingdom
Colchester, CO4 5JL, United Kingdom
London, NW1 2BU, United Kingdom
Manchester, M23 9LT, United Kingdom
Northwood, HA6 2RN, United Kingdom
Sheffield South Yorkshire, S10 2SS, United Kingdom