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Phase 2 Withdrawn Yonsei University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

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

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