A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer - PACIFIC
Study identifier:D4191C00001
ClinicalTrials.gov identifier:NCT02125461
EudraCT identifier:2014-000336-42
CTIS identifier:N/A
Study Complete
Official Title
A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
Medical condition
Non-small Cell Lung Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
MEDI4736
Sex
All
Actual Enrollment
713
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 07 May 2014
Primary Completion Date: 13 Feb 2017
Study Completion Date: 24 Aug 2023
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI4736 MEDI4736 (intravenous infusion) | Drug: MEDI4736 MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo). |
| Placebo Comparator: PLACEBO Placebo (matching placebo for intravenous infusion) | Other: PLACEBO PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo). |
Contacts
Investigators
Principal Investigator
Phil Dennis
AstraZeneca
