Last updated on December 2018

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).


Brief description of study

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Detailed Study Description

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Clinical Study Identifier: NCT03164616

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Phoenix, AZ United States
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Bakersfield, CA United States
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Los Angeles, CA United States
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San Luis Obispo, CA United States
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Santa Monica, CA United States
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Fort Myers, FL United States
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Jacksonville, FL United States
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Saint Petersburg, FL United States
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West Palm Beach, FL United States
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Honolulu, HI United States
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Louisville, KY United States
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Edina, MN United States
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Rochester, MN United States
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Kansas City, MO United States
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Albuquerque, NM United States
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Poughkeepsie, NY United States
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White Plains, NY United States
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Charlotte, NC United States
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Canton, OH United States
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Columbus, OH United States
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Pittsburgh, PA United States
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Chattanooga, TN United States
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Nashville, TN United States
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Fort Worth, TX United States
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Houston, TX United States
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Richmond, VA United States
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Busan, Korea, Republic of
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Chungcheongbuk-do, Korea, Republic of
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Daegu, Korea, Republic of
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Incheon, Korea, Republic of
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Seongnam-si, Korea, Republic of
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Seoul, Korea, Republic of
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Ulsan, Korea, Republic of
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Cuautitlan Izcalli, Mexico
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Moscow, Russian Federation
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Omsk, Russian Federation
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Saint-Petersburg, Russian Federation
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St. Petersburg, Russian Federation
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Ufa, Russian Federation
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Yaroslavl, Russian Federation
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Johannesburg, South Africa
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Kraaifontein, South Africa
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Rondebosch, South Africa
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Vereeniging, South Africa
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Dnipropetrovsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Leicester, United Kingdom
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Manchester, United Kingdom
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Panagyurishte, Bulgaria
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São José do Rio Preto, Brazil
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Törökbálint, Hungary
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Recruitment Status: Open


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