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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
drug: standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001 Arm A (consolidation only arm) will be treated with standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001 regimen. --For concurrent chemoradiation therapy, chemotherapeutic agents will follow the one of the two regimens of standard of care Paclitaxel 45 mg/m2 at D1, D8, D15, D22, D29, and D36, IV infusion; Carboplatin AUC 2 at D1, D8, D15, D22, D29, and D36, IV infusion Etoposide 50 mg/m2 D1-5, D29-33,IV infusion; Cisplatin 50 mg/m2 D1, D8, D29, and D36; IV infusion - Concurrent radiation therapy (generally, 60 Gy/30 Fx ±10%) - Consolidation therapy: after 2 weeks after completion of radiation therapy (± 7 days), PDR001 400 mg every 4 weeks, until disease progression or an unacceptable adverse event, maximum 12 months.
drug:PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001 Arm B (concurrent arm) will be treated with PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001 regimen. -For concurrent chemoradiation therapy, chemotherapeutic agents will follow one of the two regimens of standard of care Paclitaxel 45 mg/m2 at D1, D8, D15, D22, D29, and D36, IV infusion; Carboplatin AUC 2 at D1, D8, D15, D22, D29, and D36, IV infusion Etoposide 50 mg/m2 D1-5, D29-33,IV infusion; Cisplatin 50 mg/m2 days 1,8,29, and 36; IV infusion - Concurrent PDR001 400mg at D1, D29 - Concurrent radiation therapy (generally, 60 Gy/30 Fx ±10%) - Consolidation therapy: after 4 weeks after last dose of PDR001, PDR001 400 mg every 4 weeks, until disease progression or an unacceptable adverse event, maximum 12 months.
Department of Oncology, Yonsei University College of Medicine
Seoul, South Korea
Progression Free survival (PFS)
To compare the progression free survival (PFS) in concurrent plus consolidation PDR001 vs. consolidation PDR001 only in addition to standard platinum-based concurrent chemoradiation, in the patients with locally advanced, unresectable stage III NSCLC.
Time frame: Repeated tumor imaging will be performed every 8 weeks from randomization until the date of disease progression or up to 18 months. And Tumor Imaging Change will assessed by RECIST 1.1
To evaluate antitumor efficacy of PDR001: OS
To evaluate the overall survival (OS) of PDR001 as concurrent plus consolidation versus consolidation only treatment in addition to platinum-based concurrent chemoradiation, in the patients with locally advanced, unresectable stage III NSCLC.
Time frame: Repeated tumor imaging will be performed every 8 weeks from randomization until the date of disease progression or up to 18 months. And Tumor Imaging Change will assessed by RECIST 1.1
To evaluate antitumor efficacy of PDR001: ORR
To compare objective response rate (ORR; evaluated by RECIST) of the patients who received platinum-based concurrent chemoradiation with or without concurrent PDR001.
Time frame: Repeated tumor imaging will be performed every 8 weeks from randomization until the date of disease progression or up to 18 months. And Tumor Imaging Change will assessed by RECIST 1.1
Incidence of Treatment-Emergent Adverse Events[Safety and Tolerability)
To evaluate the safety and tolerability profile of PDR001 as concurrent plus consolidation versus consolidation only treatment in addition to platinum-based concurrent chemoradiation.
Time frame: Repeated tumor imaging will be performed every 8 weeks from randomization until the date of disease progression or up to 18 months. And Tumor Imaging Change will assessed by RECIST 1.1
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