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 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
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) |