Trials / Active Not Recruiting
Active Not RecruitingNCT05635708
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Administered by intravenous infusion |
| DRUG | BGB-A445 | Administered by intravenous infusion |
| DRUG | LBL-007 | Administered by intravenous infusion |
| DRUG | Carboplatin | Investigator's choice; administered by intravenous infusion |
| DRUG | Cisplatin | Investigator's choice; administered by intravenous infusion |
| DRUG | pemetrexed | Investigator's choice; administered by intravenous infusion |
| DRUG | Paclitaxel | Investigator's choice; administered by intravenous infusion |
| DRUG | Nab paclitaxel | Investigator's choice; administered by intravenous infusion |
| DRUG | BGB-15025 | Administered Orally |
Timeline
- Start date
- 2023-03-07
- Primary completion
- 2025-12-31
- Completion
- 2026-10-01
- First posted
- 2022-12-02
- Last updated
- 2026-04-15
Locations
61 sites across 15 countries: United States, Australia, Brazil, Canada, China, France, Georgia, Italy, Malaysia, Moldova, Romania, Singapore, South Korea, Spain, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05635708. Inclusion in this directory is not an endorsement.