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)
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
Outcome
Outcome not reported
Stopped (Enrollment): “Due to the delay in the study shceduled, due to the start of competitive study and the approval of Durvalumab from the Ministry of Food and Drug Safety, it was judged that it was difficult to enroll subjects.”
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 |