NCT03358875

Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.

Detailed description

This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab administered by intravenous (IV) infusion
DRUG	Docetaxel	Docetaxel administered as an IV infusion over 1 hour

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-07-15
• Completion: 2024-01-18
• First posted: 2017-12-02
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

121 sites across 10 countries: Brazil, Bulgaria, China, Lithuania, Mexico, New Zealand, Poland, Russia, Slovakia, Turkey (Türkiye)