The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
453
administered via Intravenous (IV) injection
administered via IV infusion
administered via IV infusion
Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
Time frame: Up to 3 months following completion of neoadjuvant treatment
Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)
Time frame: Up to 5 years
Overall survival (OS) in the ITT set
Time frame: Up to 5 years
Pathological complete response (pCR) rate
Time frame: Up to 5 years
Objective Response Rate (ORR)
Time frame: Up to 5 years
Disease-Free Survival (DFS) in ITT analysis set
Time frame: Up to 5 years
Event-free survival (EFS) Assessed by the Investigator
Time frame: Up to 5 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 5 years
Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire
Time frame: Up to 5 years
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administered via IV infusion
Placebo to match tislelizumab IV infusion
administered via IV infusion
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
...and 34 more locations