Clinical Trial: 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)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | BeiGene |
| Information Provided By: | BeiGene |
| Last Update Posted: | 2025-02-10 |
Study Overview
Brief 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.
Official Title
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tislelizumab
- Drug: Docetaxel
Other Study ID Numbers
- BGB-A317-303
- 2018-000245-39
- CTR20171112
- 2018
Start Date (Actual)
2017-11-30
Primary Completion Date (Actual)
2021-07-15
Study Completion Date (Actual)
2024-01-18
Enrollment (Actual)
805
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | BeiGene |
| Information Provided By: | BeiGene |
| Last Update Posted: | 2025-02-10 |
Study Overview
Brief 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.
Official Title
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tislelizumab
- Drug: Docetaxel
Other Study ID Numbers
- BGB-A317-303
- 2018-000245-39
- CTR20171112
- 2018
Start Date (Actual)
2017-11-30
Primary Completion Date (Actual)
2021-07-15
Study Completion Date (Actual)
2024-01-18
Enrollment (Actual)
805
Study Type
Interventional
Phase
Phase 3