Study of Durvalumab Given with Chemoradiation Therapy in Patients with Unresectable Non-small Cell Lung Cancer
Study identifier:D933KC00001
ClinicalTrials.gov identifier:NCT03519971
EudraCT identifier:2017-004397-34
CTIS identifier:N/A
Recruitment Complete
Official Title
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)
Medical condition
Non-small Cell Lung Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, Cisplatin/ Etoposide, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin, Pemetrexed/ Carboplatin
Sex
All
Actual Enrollment
328
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 29 Mar 2018
Primary Completion Date: 07 Sept 2023
Estimated Study Completion Date: 31 Oct 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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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) |
Contacts
Investigators
Principal Investigator
Jeffrey Bradley
AstraZeneca
