Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non Small Cell Lung Cancer
Age (in years)
18+
Phase
PHASE3
Participants needed
453
Est. Completion Date
Nov 30, 2025
Treatment type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04379635
Study number
BGB-A317-315
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