A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 453
- Locations
- 45
- Primary Endpoint
- Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Histologically confirmed Stage II or IIIA NSCLC
- •Measurable disease as assessed per RECIST v1.1
- •Confirm eligibility for an R0 resection with curative intent
Exclusion Criteria
- •Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
- •Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
- •Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Tislelizumab (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Cisplatin injection (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Paclitaxel injection (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Pemetrexed Disodium (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Carboplatin (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Cisplatin injection (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Paclitaxel injection (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Pemetrexed Disodium (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Placebos (Drug)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Overall survival (OS) in the ITT set(Up to 5 years)
- Pathological complete response (pCR) rate(Up to 5 years)
- Objective Response Rate (ORR)(Up to 5 years)
- Disease-Free Survival (DFS) in ITT analysis set(Up to 5 years)
- Event-free survival (EFS) Assessed by the Investigator(Up to 5 years)
- Number of participants experiencing treatment-emergent adverse events (TEAEs)(Up to 5 years)
- Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire(Up to 5 years)