Non Small Cell Lung Cancer
Conditions
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 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.
Interventions
DRUGTislelizumab
administered via Intravenous (IV) injection
DRUGCisplatin injection
administered via IV infusion
DRUGPaclitaxel injection
administered via IV infusion
DRUGPemetrexed Disodium
administered via IV infusion
DRUGPlacebos
Placebo to match tislelizumab IV infusion
DRUGCarboplatin
administered via IV infusion
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Contacts
STUDY_DIRECTORStudy Director
BeiGene
Outcome results
None listed