For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  2. Histologically confirmed Stage II or IIIA NSCLC
  3. Measurable disease as assessed per RECIST v1.1
  4. Confirm eligibility for an R0 resection with curative intent

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
  2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
  3. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse
  5. 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.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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