drugset / Trial / NCT04940637
UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma (MPM), and positive for PD-L1 expression (TPS ≥ 1%) and germline or somatic mutations in the DNA homologous recombination repair (HRR) genes.
Timeline
- Start
- 2020-12-23
- Primary completion
- 2024-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dostarlimab | Monoclonal antibody | 1000 mg | — |
| Subject | Niraparib | Small molecule | 300 mg | — |