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

Find a site near you

Start Over

Research Site

Phoenix, AZ United States
  Connect »

Research Site

Bakersfield, CA United States
  Connect »

Research Site

Los Angeles, CA United States
  Connect »

Research Site

San Luis Obispo, CA United States
  Connect »

Research Site

Santa Monica, CA United States
  Connect »

Research Site

Fort Myers, FL United States
  Connect »

Research Site

Jacksonville, FL United States
  Connect »

Research Site

Saint Petersburg, FL United States
  Connect »

Research Site

West Palm Beach, FL United States
  Connect »

Research Site

Honolulu, HI United States
  Connect »

Research Site

Louisville, KY United States
  Connect »

Research Site

Edina, MN United States
  Connect »

Research Site

Rochester, MN United States
  Connect »

Research Site

Kansas City, MO United States
  Connect »

Research Site

Albuquerque, NM United States
  Connect »

Research Site

Poughkeepsie, NY United States
  Connect »

Research Site

White Plains, NY United States
  Connect »

Research Site

Charlotte, NC United States
  Connect »

Research Site

Canton, OH United States
  Connect »

Research Site

Columbus, OH United States
  Connect »

Research Site

Pittsburgh, PA United States
  Connect »

Research Site

Chattanooga, TN United States
  Connect »

Research Site

Nashville, TN United States
  Connect »

Research Site

Fort Worth, TX United States
  Connect »

Research Site

Houston, TX United States
  Connect »

Research Site

Richmond, VA United States
  Connect »

Research Site

Barretos, Brazil
  Connect »

Research Site

Belo Horizonte, Brazil
  Connect »

Research Site

Curitiba, Brazil
  Connect »

Research Site

Porto Alegre, Brazil
  Connect »

Research Site

Ribeirao Preto, Brazil
  Connect »

Research Site

Rio de Janeiro, Brazil
  Connect »

Research Site

Sao Paulo, Brazil
  Connect »

Research Site

Plovdiv, Bulgaria
  Connect »

Research Site

Freiburg, Germany
  Connect »

Research Site

Gauting, Germany
  Connect »

Research Site

Hamburg, Germany
  Connect »

Research Site

Heidelberg, Germany
  Connect »

Research Site

Immenhausen, Germany
  Connect »

Research Site

Oldenburg, Germany
  Connect »

Research Site

Iwakuni-shi, Japan
  Connect »

Research Site

Matsuyama-shi, Japan
  Connect »

Research Site

Okayama-shi, Japan
  Connect »

Research Site

Sapporo-shi, Japan
  Connect »

Research Site

Sunto-gun, Japan
  Connect »

Research Site

Yokohama-shi, Japan
  Connect »

Research Site

Busan, Korea, Republic of
  Connect »

Research Site

Chungcheongbuk-do, Korea, Republic of
  Connect »

Research Site

Daegu, Korea, Republic of
  Connect »

Research Site

Incheon, Korea, Republic of
  Connect »

Research Site

Seongnam-si, Korea, Republic of
  Connect »

Research Site

Seoul, Korea, Republic of
  Connect »

Research Site

Ulsan, Korea, Republic of
  Connect »

Research Site

Aguascalientes, Mexico
  Connect »

Research Site

Cuautitlan Izcalli, Mexico
  Connect »

Research Site

Guadalajara, Mexico
  Connect »

Research Site

Monterrey, Mexico
  Connect »

Research Site

San Isidro, Peru
  Connect »

Research Site

Moscow, Russian Federation
  Connect »

Research Site

Omsk, Russian Federation
  Connect »

Research Site

Saint-Petersburg, Russian Federation
  Connect »

Research Site

St. Petersburg, Russian Federation
  Connect »

Research Site

Ufa, Russian Federation
  Connect »

Research Site

Yaroslavl, Russian Federation
  Connect »

Research Site

Durban, South Africa
  Connect »

Research Site

Johannesburg, South Africa
  Connect »

Research Site

Kraaifontein, South Africa
  Connect »

Research Site

Pretoria, South Africa
  Connect »

Research Site

Rondebosch, South Africa
  Connect »

Research Site

Vereeniging, South Africa
  Connect »

Research Site

Changhua City, Taiwan
  Connect »

Research Site

Kaohsiung, Taiwan
  Connect »

Research Site

Taichung, Taiwan
  Connect »

Research Site

Tao-Yuan, Taiwan
  Connect »

Research Site

Bangkok, Thailand
  Connect »

Research Site

Chom Thon, Thailand
  Connect »

Research Site

Songkla, Thailand
  Connect »

Research Site

Dnipropetrovsk, Ukraine
  Connect »

Research Site

Ivano-Frankivsk, Ukraine
  Connect »

Research Site

Vinnytsia, Ukraine
  Connect »

Research Site

Zaporizhzhya, Ukraine
  Connect »

Research Site

Leicester, United Kingdom
  Connect »

Research Site

London, United Kingdom
  Connect »

Research Site

Manchester, United Kingdom
  Connect »

Research Site

Panagyurishte, Bulgaria
  Connect »

Research Site

Changchun, China
  Connect »

Research Site

Chongqing, China
  Connect »

Research Site

Guangzhou, China
  Connect »

Research Site

Zhanjiang, China
  Connect »

Research Site

Zhengzhou, China
  Connect »

Research Site

Shatin, Hong Kong
  Connect »

Research Site

Bunkyo-ku, Japan
  Connect »

Research Site

Fukuoka-shi, Japan
  Connect »

Research Site

Hiroshima-shi, Japan
  Connect »

Research Site

Kurume-shi, Japan
  Connect »

Research Site

Osakasayama, Japan
  Connect »

Research Site

Ho Chi Minh, Vietnam
  Connect »

Research Site

Budapest, Hungary
  Connect »

Research Site

Miskolc, Hungary
  Connect »

Research Site

Toyoake-shi, Japan
  Connect »

Research Site

Florianópolis, Brazil
  Connect »

Research Site

Santo André, Brazil
  Connect »

Research Site

São José do Rio Preto, Brazil
  Connect »

Research Site

São Paulo, Brazil
  Connect »

Research Site

Großhansdorf, Germany
  Connect »

Research Site

Würzburg, Germany
  Connect »

Research Site

Kecskemét, Hungary
  Connect »

Research Site

Törökbálint, Hungary
  Connect »

Research Site

Córdoba, Mexico
  Connect »