Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Cisplatin injection
* Drug: Paclitaxel injection
* Drug: Pemetrexed Disodium
* Drug: Placebos
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab<br>Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium | Drug: Tislelizumab<br>* administered via Intravenous (IV) injection<br>* Other names: BGB-A317;Drug: Cisplatin injection<br>* administered via IV infusion<br>Drug: Paclitaxel injection<br>* administered via IV infusion<br>Drug: Pemetrexed Disodium<br>* administered via IV infusion<br>Drug: Carboplatin<br>* administered via IV infusion<br>|
| Placebo Comparator: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo<br>Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium | Drug: Cisplatin injection<br>* administered via IV infusion<br>Drug: Paclitaxel injection<br>* administered via IV infusion<br>Drug: Pemetrexed Disodium<br>* administered via IV infusion<br>Drug: Placebos<br>* Placebo to match tislelizumab IV infusion<br>Drug: Carboplatin<br>* administered via IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set |  | 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) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |