drugset / Trial / NCT03945227
Clinical Trial for Evaluating Efficacy and Safety of PDR001 in Concurrent Plus Consolidation Versus Consolidation Only in Addition to Standard Chemoradiotherapy in Unresectable Stage III NSCLC Patients (PASTURE)
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, randomized Phase 2 trial evaluating PDR001 in two arms for concurrent chemoradiation and consolidation in the treatment-naïve patients with locally advanced, unresectable stage III NSCLC. Patients will be randomized in a 1:1 ratio (arm A and arm B): * Arm A (consolidation only arm) will be treated with standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001 regimen. * Arm B (concurrent arm) will be treated with PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001 regimen.
Timeline
- Start
- 2019-06
- Primary completion
- 2022-01
- Completion
- 2022-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spartalizumab | Monoclonal antibody | 400 mg | — |
| Comparator | Carboplatin | Small molecule | 2 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 45 mg/m2 | Intravenous |