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NCT03164616Active, not recruitingPhase 3

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

A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)

Source: ClinicalTrials.gov · Last updated 13 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1186 (actual)
First submitted
22 May 2017
Start date
1 Jun 2017
Primary completion date
12 Mar 2021
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT03164616
EudraCT number
2017-000920-81

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1186
  • From 1 Jun 2017 to the primary completion date, 12 Mar 2021
  • 134 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active or prior documented autoimmune or inflammatory disorders.

Other illness

  • Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
  • Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Other

  • Patients should not enter the study if any of the following exclusion criteria are fulfilled:

Who the study is looking for

  • For inclusion in the study, patients should fulfill the following criteria:
  • Aged at least 18 years.
  • Histologically or cytologically documented Stage IV NSCLC.
  • Confirmed tumor PD-L1 status prior to randomization.
  • Patients must have tumors that lack activating EGFR mutations and ALK fusions.
  • No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (134)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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PlovdivBulgariaUnknown status
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SofiaBulgariaUnknown status
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VarnaBulgariaUnknown status
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BarretosBrazilUnknown status
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Belo HorizonteBrazilUnknown status
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CuritibaBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Ribeirão PretoBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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Santo AndréBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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BeijingChinaUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HarbinChinaUnknown status
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HefeiChinaUnknown status
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KunmingChinaUnknown status
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LinyiChinaUnknown status
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LiuzhouChinaUnknown status
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NanjingChinaUnknown status
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QingdaoChinaUnknown status
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ShanghaiChinaUnknown status
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ShantouChinaUnknown status
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WuhanChinaUnknown status
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XiningChinaUnknown status
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YangzhouChinaUnknown status
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ZhanjiangChinaUnknown status
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ZhengzhouChinaUnknown status
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BerlinGermanyUnknown status
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EssenGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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GautingGermanyUnknown status
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HamburgGermanyUnknown status
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HeidelbergGermanyUnknown status
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ImmenhausenGermanyUnknown status
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MainzGermanyUnknown status
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OldenburgGermanyUnknown status
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WürzburgGermanyUnknown status
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LeicesterUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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ShatinHong Kong SAR ChinaUnknown status
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BudapestHungaryUnknown status
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KecskemétHungaryUnknown status
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MiskolcHungaryUnknown status
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TörökbálintHungaryUnknown status
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Bunkyō CityJapanUnknown status
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ChūōkuJapanUnknown status
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FukuokaJapanUnknown status
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HiroshimaJapanUnknown status
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Iwakuni-shiJapanUnknown status
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KanazawaJapanUnknown status
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KashiwaJapanUnknown status
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KōtokuJapanUnknown status
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Kurume-shiJapanUnknown status
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MatsuyamaJapanUnknown status
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OkayamaJapanUnknown status
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SapporoJapanUnknown status
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SayamaJapanUnknown status
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Sunto-gunJapanUnknown status
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Toyoake-shiJapanUnknown status
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Ube-shiJapanUnknown status
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YokohamaJapanUnknown status
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BusanSouth KoreaUnknown status
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Chungcheongbuk-doSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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UlsanSouth KoreaUnknown status
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AguascalientesMexicoUnknown status
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Cuautitlán IzcalliMexicoUnknown status
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GuadalajaraMexicoUnknown status
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MéxicoMexicoUnknown status
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Mexico CityMexicoUnknown status
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MonterreyMexicoUnknown status
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Tuxtla GutiérrezMexicoUnknown status
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ArequipaPeruUnknown status
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LimaPeruUnknown status
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San IsidroPeruUnknown status
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OlsztynPolandUnknown status
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Tomaszów MazowieckiPolandUnknown status
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WarsawPolandUnknown status
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Wodzisław ŚląskiPolandUnknown status
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MoscowRussiaUnknown status
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OmskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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BangkokThailandUnknown status
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MuangThailandUnknown status
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SongkhlaThailandUnknown status
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ChanghuaTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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DniproUkraineUnknown status
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Ivano-FrankivskUkraineUnknown status
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KirovohradUkraineUnknown status
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KyivUkraineUnknown status
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LvivUkraineUnknown status
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OdesaUkraineUnknown status
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SumyUkraineUnknown status
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VinnytsiaUkraineUnknown status
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ZaporizhzhyaUkraineUnknown status
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BakersfieldUnited StatesUnknown status
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CantonUnited StatesUnknown status
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ChattanoogaUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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Fort WorthUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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Santa MonicaUnited StatesUnknown status
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St. PetersburgUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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HanoiVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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Cape TownSouth AfricaUnknown status
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DurbanSouth AfricaUnknown status
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JohannesburgSouth AfricaUnknown status
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ParktownSouth AfricaUnknown status
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PretoriaSouth AfricaUnknown status
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RondeboschSouth AfricaUnknown status
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VereenigingSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.