Status:
ACTIVE_NOT_RECRUITING
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
BeiGene
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ch...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT04379635
Start Date
May 29 2020
End Date
March 31 2027
Last Update
November 21 2025
Active Locations (44)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
4
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053