A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT ID: NCT02125461
Last Updated: 2023-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
713 participants
INTERVENTIONAL
2014-05-07
2023-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MEDI4736
MEDI4736 (intravenous infusion)
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
Placebo (matching placebo for intravenous infusion)
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).
Interventions
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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
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
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Inclusion Criteria
2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
4. World Health Organisation (WHO) Performance Status of 0 to 1.
5. Estimated life expectancy of more than 12 weeks.
Exclusion Criteria
2. Active or prior autoimmune disease or history of immunodeficiency.
3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Phil Dennis, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Chandler, Arizona, United States
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Goodyear, Arizona, United States
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Jonesboro, Arkansas, United States
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Springdale, Arkansas, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Oxnard, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Miami Beach, Florida, United States
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Orlando, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Fort Gordon, Georgia, United States
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
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Waterloo, Iowa, United States
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Topeka, Kansas, United States
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Hazard, Kentucky, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Rosedale, Maryland, United States
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Salisbury, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Hackensack, New Jersey, United States
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Lake Success, New York, United States
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The Bronx, New York, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Pinehurst, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Blue Ash, Ohio, United States
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Easley, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Bedford Park, , Australia
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Bendigo, , Australia
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Box Hill, , Australia
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Clayton, , Australia
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Heidelberg, , Australia
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Herston, , Australia
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Kogarah, , Australia
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Launceston, , Australia
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Nedlands, , Australia
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Port Macquarie, , Australia
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Randwick, , Australia
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Westmead, , Australia
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Woolloongabba, , Australia
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Aalst, , Belgium
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Gilly, , Belgium
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Leuven, , Belgium
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Libramont-Chevigny, , Belgium
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Liège, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, , Canada
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Santiago, , Chile
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Santiago, , Chile
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Viña del Mar, , Chile
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Avignon, , France
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Bayonne, , France
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Brest, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Pau, , France
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Rennes, , France
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Saint-Herblain, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Berlin, , Germany
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Esslingen am Neckar, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Löwenstein, , Germany
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Recklinghausen, , Germany
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Regensburg, , Germany
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Villingen-Schwenningen, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Miskolc, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Aviano, , Italy
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Catania, , Italy
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Cremona, , Italy
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Lecce, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Habikino-shi, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Natori-shi, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Sagamihara-shi, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sayama, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Takatsuki-shi, , Japan
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Ube-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Cuautitlán Izcalli, , Mexico
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Monterrey, , Mexico
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Oaxaca City, , Mexico
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Orizaba, , Mexico
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Lima, , Peru
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Lima, , Peru
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Gdansk, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Bardejov, , Slovakia
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Košice, , Slovakia
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Nové Zámky, , Slovakia
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Trnava, , Slovakia
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Cape Town, , South Africa
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Pretoria, , South Africa
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Vereeniging, , South Africa
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Busan, , South Korea
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Cheongju-si, , South Korea
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Hwasun-gun, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Girona, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Glasgow, , United Kingdom
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Manchester, , United Kingdom
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Truro, , United Kingdom
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Senan 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.
Naidoo 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.
Spigel 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.
Ouwens 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.
Socinski 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.
Garassino 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.
Mehra 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.
Faivre-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.
Faivre-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.
Paz-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.
Gray 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.
Hui 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.
Antonia 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.
Antonia 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
AstraZeneca Cancer Study Locator Service [email protected] 1-877-400-465
Other Identifiers
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2014-000336-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4191C00001
Identifier Type: -
Identifier Source: org_study_id
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