Study identifier:D933KC00001
ClinicalTrials.gov identifier:NCT03519971
EudraCT identifier:2017-004397-34
CTIS identifier:2024-515321-29-00
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-based Chemoradiation Therapy in Patients with Locally Advanced, Unresectable NSCLC (Stage III) (PACIFIC2)
Non-small Cell Lung Cancer
Phase 3
No
Durvalumab, Cisplatin/ Etoposide, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin, Pemetrexed/ Carboplatin
All
328
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Location
Location
Bangkok, Thailand, 10330
Location
Hat Yai, Thailand, 90110
Location
Mueang, Thailand, 50200
Location
Khon Kaen, Thailand, 40002
Location
Bangkok, Thailand, 10400
Location
Ankara, Turkey
Location
Antalya, Turkey, 07059
Location
Izmir, Turkey, 35100
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy and radiation Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment. | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Cisplatin/ Etoposide Cisplatin/ Etoposide, as per standard of care Drug: Carboplatin/ Paclitaxel Carboplatin /Paclitaxel, as per standard of care Drug: Pemetrexed/ Cisplatin Pemetrexed / Cisplatin, as per standard of care Drug: Pemetrexed/ Carboplatin Pemetrexed / Carboplatin , as per standard of care Radiation: Radiation 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy) |
Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy and radiation Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment. | Other: Placebo Placebo IV (intravenous infusion) Drug: Cisplatin/ Etoposide Cisplatin/ Etoposide, as per standard of care Drug: Carboplatin/ Paclitaxel Carboplatin /Paclitaxel, as per standard of care Drug: Pemetrexed/ Cisplatin Pemetrexed / Cisplatin, as per standard of care Drug: Pemetrexed/ Carboplatin Pemetrexed / Carboplatin , as per standard of care Radiation: Radiation 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy) |
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