A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
PACIFIC
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)
2 other identifiers
interventional
713
26 countries
236
Brief Summary
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started May 2014
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
236 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2017
CompletedResults Posted
Study results publicly available
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2023
CompletedOctober 10, 2023
September 1, 2023
2.8 years
April 25, 2014
February 13, 2018
September 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Overall Survival
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Secondary Outcomes (11)
Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
- +6 more secondary outcomes
Study Arms (2)
MEDI4736
EXPERIMENTALMEDI4736 (intravenous infusion)
PLACEBO
PLACEBO COMPARATORPlacebo (matching placebo for intravenous infusion)
Interventions
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 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).
Eligibility Criteria
You may qualify if:
- Age at least 18 years.
- Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
- Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
- World Health Organisation (WHO) Performance Status of 0 to 1.
- Estimated life expectancy of more than 12 weeks.
You may not qualify if:
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- Active or prior autoimmune disease or history of immunodeficiency.
- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (236)
Research Site
Chandler, Arizona, 85224, United States
Research Site
Goodyear, Arizona, 85338, United States
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Jonesboro, Arkansas, 72405, United States
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Springdale, Arkansas, 72762, United States
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Fullerton, California, 92835, United States
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Los Angeles, California, 90095, United States
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Oxnard, California, 93030, United States
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Sacramento, California, 95816, United States
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San Diego, California, 92123, United States
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Santa Rosa, California, 95403, United States
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Norwich, Connecticut, 06360, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32207, United States
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Miami Beach, Florida, 33140, United States
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Orlando, Florida, 32804, United States
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Port Saint Lucie, Florida, 34952, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Fort Gordon, Georgia, 30905, United States
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Lawrenceville, Georgia, 30046, United States
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Marietta, Georgia, 30060, United States
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Waterloo, Iowa, 50701, United States
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Topeka, Kansas, 66606, United States
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Hazard, Kentucky, 41701, United States
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Baltimore, Maryland, 21287, United States
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Rockville, Maryland, 20850, United States
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Rosedale, Maryland, 21237, United States
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Salisbury, Maryland, 21801, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02215, United States
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Lansing, Michigan, 48910, United States
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Minneapolis, Minnesota, 55426, United States
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St Louis, Missouri, 63110, United States
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Lincoln, Nebraska, 68510, United States
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Hackensack, New Jersey, 07601, United States
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Lake Success, New York, 11041, United States
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The Bronx, New York, 10461, United States
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Burlington, North Carolina, 27215, United States
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Charlotte, North Carolina, 28204, United States
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Pinehurst, North Carolina, 28374, United States
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Winston-Salem, North Carolina, 27103, United States
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Blue Ash, Ohio, 45242, United States
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Easley, South Carolina, 29640, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232-8805, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Salt Lake City, Utah, 84106, United States
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Fairfax, Virginia, 22031, United States
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Spokane, Washington, 99208, United States
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Spokane, Washington, 99218, United States
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Vancouver, Washington, 98684, United States
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Bedford Park, 5042, Australia
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Bendigo, 3550, Australia
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Box Hill, 3128, Australia
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Clayton, 3168, Australia
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Heidelberg, 3084, Australia
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Herston, 4029, Australia
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Kogarah, 2217, Australia
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Launceston, 7250, Australia
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Nedlands, 6009, Australia
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Port Macquarie, 2444, Australia
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Randwick, 2031, Australia
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Westmead, 2145, Australia
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Woolloongabba, 4102, Australia
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Aalst, 9300, Belgium
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Gilly, 6060, Belgium
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Leuven, 3000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Liège, 4000, Belgium
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Barrie, Ontario, L4M 6M2, Canada
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London, Ontario, N6A 4L6, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, M5G 2M9, Canada
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Santiago, 7500000, Chile
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Santiago, 8420383, Chile
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Viña del Mar, Chile
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Avignon, 84918, France
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Bayonne, 64100, France
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Brest, 29609, France
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Lille, 59037, France
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Lyon, 69008, France
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Marseille, 13915, France
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Montpellier, 34295, France
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Nantes, 44202, France
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Nice, 06100, France
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Pau, 6400, France
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Rennes, 35033, France
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Saint-Herblain, 44805, France
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Toulouse, 31000, France
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Villejuif, 94805, France
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Berlin, 10967, Germany
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Berlin, 12351, Germany
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Esslingen am Neckar, 73730, Germany
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Großhansdorf, 20927, Germany
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Hamburg, 20251, Germany
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Hamburg, 22081, Germany
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Löwenstein, 74245, Germany
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Recklinghausen, 45659, Germany
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Regensburg, 93053, Germany
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Villingen-Schwenningen, 78052, Germany
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 54645, Greece
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Thessaloniki, 57010, Greece
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Gyula, 5703, Hungary
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Miskolc, 3529, Hungary
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Aviano, 33081, Italy
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Catania, 95123, Italy
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Cremona, 26100, Italy
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Lecce, 73100, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Napoli, 80138, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Habikino-shi, 583-8588, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Natori-shi, 981-1293, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sayama, 589-8511, Japan
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Sendai, 980-0873, Japan
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Shinjuku-ku, 162-8655, Japan
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Sunto-gun, 411-8777, Japan
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Takatsuki-shi, 569-8686, Japan
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Ube-shi, 755-0241, Japan
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Yokohama, 236-0051, Japan
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Yokohama, 241-8515, Japan
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Cuautitlán Izcalli, 54769, Mexico
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Monterrey, 64460, Mexico
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Oaxaca City, 68000, Mexico
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Orizaba, 94300, Mexico
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623EJ, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Tilburg, 5022 GC, Netherlands
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Lima, 41, Peru
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Lima, LIMA 27, Peru
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Gdansk, 80-952, Poland
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Lublin, 20-362, Poland
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Warsaw, 02-781, Poland
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Singapore, 119074, Singapore
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Singapore, 169610, Singapore
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Singapore, 308433, Singapore
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Bardejov, 08501, Slovakia
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Košice, 041 91, Slovakia
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Nové Zámky, 94002, Slovakia
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Trnava, 91775, Slovakia
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Cape Town, 7570, South Africa
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Pretoria, 0181, South Africa
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Vereeniging, 1930, South Africa
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Busan, 49201, South Korea
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Cheongju-si, 361-711, South Korea
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Hwasun-gun, 58128, South Korea
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Incheon, UNK, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Suwon, 16247, South Korea
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Alicante, 03010, Spain
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Barcelona, 08003, Spain
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Barcelona, 08041, Spain
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Barcelona, 08908, Spain
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Donostia / San Sebastian, 20014, Spain
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Girona, 17007, Spain
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Lleida, 25198, Spain
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Madrid, 28005, Spain
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Madrid, 28007, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28050, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Taichung, 40447, Taiwan
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Taipei, 110, Taiwan
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Taipei, 112, Taiwan
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Taipei, 23561, Taiwan
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Taipei, Taiwan
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Bangkok, 10400, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Adana, 01130, Turkey (Türkiye)
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Ankara, 06490, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Glasgow, G12 0YN, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (15)
Naidoo J, Antonia S, Wu YL, Cho BC, Thiyagarajah P, Mann H, Newton M, Faivre-Finn C. Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutant NSCLC: A Post Hoc Subgroup Analysis From PACIFIC. J Thorac Oncol. 2023 May;18(5):657-663. doi: 10.1016/j.jtho.2023.02.009. Epub 2023 Feb 24.
PMID: 36841540DERIVEDSenan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2.
PMID: 35247871DERIVEDNaidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9.
PMID: 35245844DERIVEDSpigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2.
PMID: 35108059DERIVEDOuwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021.
PMID: 34484473DERIVEDSocinski MA, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12.
PMID: 34294595DERIVEDGarassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Ozguroglu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Ryden A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15.
PMID: 33583206DERIVEDMehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.
PMID: 33545688DERIVEDFaivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.
PMID: 33476803DERIVEDFaivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.
PMID: 33285469DERIVEDPaz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.
PMID: 32209338DERIVEDGray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.
PMID: 31622733DERIVEDHui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Ryden A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.
PMID: 31601496DERIVEDAntonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
PMID: 30280658DERIVEDAntonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PMID: 28885881DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Phil Dennis, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
May 7, 2014
Primary Completion
February 13, 2017
Study Completion
August 24, 2023
Last Updated
October 10, 2023
Results First Posted
January 30, 2019
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.