Trials / Completed
CompletedNCT05014815
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 272 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
Conditions
- Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)
- Nonsmall Cell Lung Cancer, Stage IIIB
- Nonsmall Cell Lung Cancer, Stage IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ociperlimab | 900 mg intravenously (IV) once every 3 weeks (Q3W) |
| DRUG | Tislelizumab | 200 mg IV Q3W |
| DRUG | Carboplatin | Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle |
| DRUG | Paclitaxel | 75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle |
| DRUG | Nab paclitaxel | 100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle |
| DRUG | Cisplatin | 75 mg/m², administered intravenously on Day 1 of each 21-day cycle |
| DRUG | Pemetrexed | 500 mg/m² administered intravenously on Day 1 of each 21-day cycle |
| DRUG | Placebo | Administered intravenously Q3W to match ociperlimab |
Timeline
- Start date
- 2021-11-16
- Primary completion
- 2024-09-04
- Completion
- 2024-09-04
- First posted
- 2021-08-20
- Last updated
- 2025-09-16
- Results posted
- 2025-09-16
Locations
64 sites across 8 countries: United States, Australia, Austria, China, France, Greece, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05014815. Inclusion in this directory is not an endorsement.