Trials / Active Not Recruiting
Active Not RecruitingNCT04746924
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 662 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Tislelizumab is a monoclonal antibody formulated for intravenous injection. |
| DRUG | Ociperlimab | Ociperlimab is a monoclonal antibody formulated for intravenous injection. |
| DRUG | Pembrolizumab | Pembrolizumab is a monoclonal antibody formulated for intravenous injection. |
| DRUG | Placebo | Placebo infusions will consist of a sterile, normal saline solution. |
Timeline
- Start date
- 2021-06-08
- Primary completion
- 2025-05-30
- Completion
- 2026-03-31
- First posted
- 2021-02-10
- Last updated
- 2025-06-24
Locations
218 sites across 19 countries: United States, Argentina, Australia, Brazil, China, France, Georgia, Germany, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04746924. Inclusion in this directory is not an endorsement.