Spots Global Cancer Trial Database for Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Official Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).
Study ID: NCT02453282
Conditions
Study Description
Brief Summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC
Detailed Description: Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Scottsdale, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Yuma, Arizona, United States
Research Site, Bakersfield, California, United States
Research Site, Fullerton, California, United States
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Redondo Beach, California, United States
Research Site, Sacramento, California, United States
Research Site, San Luis Obispo, California, United States
Research Site, Santa Maria, California, United States
Research Site, West Hollywood, California, United States
Research Site, New Haven, Connecticut, United States
Research Site, Jacksonville, Florida, United States
Research Site, Pembroke Pines, Florida, United States
Research Site, Tampa, Florida, United States
Research Site, Athens, Georgia, United States
Research Site, Honolulu, Hawaii, United States
Research Site, Baltimore, Maryland, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Omaha, Nebraska, United States
Research Site, Summit, New Jersey, United States
Research Site, Mineola, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Cleveland, Ohio, United States
Research Site, North Charleston, South Carolina, United States
Research Site, Nashville, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Richmond, Virginia, United States
Research Site, Madison, Wisconsin, United States
Research Site, Box Hill, , Australia
Research Site, Gosford, , Australia
Research Site, Kogarah, , Australia
Research Site, Melbourne, , Australia
Research Site, Port Macquarie, , Australia
Research Site, Southport, , Australia
Research Site, St Leonards, , Australia
Research Site, Brussels, , Belgium
Research Site, Charleroi, , Belgium
Research Site, Duffel, , Belgium
Research Site, Leuven, , Belgium
Research Site, Liège, , Belgium
Research Site, Kingston, Ontario, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, Oshawa, Ontario, Canada
Research Site, Sault Ste. Marie, Ontario, Canada
Research Site, St. Catharines, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Regina, Saskatchewan, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Bordeaux Cedex, , France
Research Site, Brest Cedex, , France
Research Site, Creteil, , France
Research Site, Lille, , France
Research Site, Lyon Cedex 08, , France
Research Site, Marseille cedex, , France
Research Site, Aachen, , Germany
Research Site, Bad Berka, , Germany
Research Site, Berlin, , Germany
Research Site, Berlin, , Germany
Research Site, Freiburg, , Germany
Research Site, Gauting, , Germany
Research Site, Hamburg, , Germany
Research Site, Heidelberg, , Germany
Research Site, Hemer, , Germany
Research Site, Homburg/Saar, , Germany
Research Site, Immenhausen, , Germany
Research Site, Lubeck, , Germany
Research Site, Löwenstein, , Germany
Research Site, Mainz, , Germany
Research Site, Münster, , Germany
Research Site, Oldenburg, , Germany
Research Site, Ulm, , Germany
Research Site, Velbert, , Germany
Research Site, Würzburg, , Germany
Research Site, Budapest, , Hungary
Research Site, Deszk, , Hungary
Research Site, Edelény, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Kecskemét, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Pécs, , Hungary
Research Site, Székesfehérvár, , Hungary
Research Site, Genova, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, San Giovanni Rotondo, , Italy
Research Site, Siena, , Italy
Research Site, Fukushima-shi, , Japan
Research Site, Himeji-shi, , Japan
Research Site, Hirakata-shi, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Iizuka-shi, , Japan
Research Site, Iwakuni-shi, , Japan
Research Site, Izumi-shi, , Japan
Research Site, Kanazawa, , Japan
Research Site, Kishiwada-shi, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Koga-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Mitaka-shi, , Japan
Research Site, Nagaoka-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama, , Japan
Research Site, Saga-shi, , Japan
Research Site, Saitama-shi, , Japan
Research Site, Sakai-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Tokushima-shi, , Japan
Research Site, Ube-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokosuka-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Changwon-si, , Korea, Republic of
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Daejeon, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seongnam-Si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon-si, , Korea, Republic of
Research Site, Ulsan, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Arnhem, , Netherlands
Research Site, Breda, , Netherlands
Research Site, Den Bosch, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, A Coruña, , Spain
Research Site, Alicante, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Gerona, , Spain
Research Site, Jaén, , Spain
Research Site, León, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Málaga, , Spain
Research Site, Sevilla, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Bellinzona, , Switzerland
Research Site, Lausanne, , Switzerland
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Tao-Yuan, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Chiang Mai, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Hanoi City, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Stuart McIntosh, MD
Affiliation: AstraZeneca, Alderley Park, Cheshire, UK
Role: STUDY_DIRECTOR
Name: Naiyer Rizvi, MD
Affiliation: Columbia University Medical Center, New York, NY, USA
Role: PRINCIPAL_INVESTIGATOR
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