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

  • STATUS
    Recruiting
  • End date
    Nov 5, 2025
  • participants needed
    380
  • sponsor
    BeiGene
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Updated on 19 February 2024
See if I qualify
cancer
immunomodulator
measurable disease
carboplatin
lung cancer
pemetrexed
paclitaxel
immunomodulators
platinum doublet
adjuvant therapy
tislelizumab
adjuvant
non-small cell lung cancer
small cell lung cancer
cisplatin

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.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age 18years - 100years
Treatment Placebos, Carboplatin, tislelizumab, Cisplatin injection, Paclitaxel injection, Pemetrexed Disodium
Clinical Study IdentifierNCT04379635
SponsorBeiGene
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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cancer
immunomodulator
measurable disease
carboplatin
lung cancer
pemetrexed
paclitaxel
immunomodulators
platinum doublet
adjuvant therapy
tislelizumab
adjuvant
non-small cell lung cancer
small cell lung cancer
cisplatin

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