Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04379635
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 453
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab Tislelizumab Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab Carboplatin Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab Cisplatin injection Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab Paclitaxel injection Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab Pemetrexed Disodium Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo Cisplatin injection Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo Paclitaxel injection Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo Pemetrexed Disodium Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo Placebos Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo Carboplatin Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (44)
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
🇨🇳Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
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