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)

NCT03945227

Phase 2 Withdrawn Yonsei University
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

EvaluationDrugModalityDoseRoute
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