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Tislelizumab in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
NCT04379635Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- May 2020
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- BeiGene
- Modality
- Monoclonal Antibodies
- Drugs
- tislelizumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, double-blind trial in non-small cell lung cancer (NSCLC) comparing Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab with Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo (2 arms). Primary endpoints: Major Pathological Response up to 3 months and Event-Free Survival up to 5 years. Started May 2020; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + chemotherapy followed by surgery and adjuvant Tislelizumab
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + chemotherapy followed by surgery and adjuvant Placebo
03
Who it enrols
Patients with resectable Stage II or IIIA NSCLC, ECOG 0-1, no prior therapy for current lung cancer, and no EGFR/ALK mutations.
04
Endpoints
Primary
Major Pathological Response
Event-Free Survival
Secondary
Overall Survival
Pathological Complete Response
Objective Response Rate
Disease-Free Survival
Event-Free Survival
Treatment-Emergent Adverse Events
Health-Related Quality of Life
05
Results
Primary endpoints met
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