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NCT02542293Active, not recruitingPhase 3

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC).

Source: ClinicalTrials.gov · Last updated 6 Aug 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 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 advanced or metastatic NSCLC.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
953 (actual)
First submitted
26 Aug 2015
Start date
3 Nov 2015
Primary completion date
21 Sept 2020
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT02542293
EudraCT number
2015-002197-21

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 953
  • From 3 Nov 2015 to the primary completion date, 21 Sept 2020
  • 161 sites in 29 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

  • Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
  • Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)

Other illness

  • Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant

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
  • Documented evidence of Stage IV NSCLC
  • No activating EGFR mutation or ALK rearrangement
  • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  • World Health Organization (WHO) Performance Status of 0 or 1
  • No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, 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 (161)

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

SiteCityCountrySite status
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BerazateguiArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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La RiojaArgentinaUnknown status
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RosarioArgentinaUnknown status
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San Salvador de JujuyArgentinaUnknown status
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Santa RosaArgentinaUnknown status
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PlovdivBulgariaUnknown status
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ShumenBulgariaUnknown status
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SofiaBulgariaUnknown status
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VarnaBulgariaUnknown status
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VratsaBulgariaUnknown status
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BarretosBrazilUnknown status
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Belo HorizonteBrazilUnknown status
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FortalezaBrazilUnknown status
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IjuíBrazilUnknown status
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ItajaíBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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SantiagoChileUnknown status
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TemucoChileUnknown status
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Viña del MarChileUnknown status
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BeijingChinaUnknown status
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ChangchunChinaUnknown status
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ChongqingChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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ShanghaiChinaUnknown status
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ÜrümqiChinaUnknown status
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WuhanChinaUnknown status
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Odense CDenmarkUnknown status
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OuluFinlandUnknown status
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TampereFinlandUnknown status
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GuildfordUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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Metropolitan Borough of WirralUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
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TauntonUnited KingdomUnknown status
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WolverhamptonUnited KingdomUnknown status
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AthensGreeceUnknown status
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HeraklionGreeceUnknown status
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Holargos, AthensGreeceUnknown status
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IoanninaGreeceUnknown status
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Hong KongHong Kong SAR ChinaUnknown status
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King's ParkHong Kong SAR ChinaUnknown status
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ShatinHong Kong SAR ChinaUnknown status
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BeershebaIsraelUnknown status
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JerusalemIsraelUnknown status
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Kfar SabaIsraelUnknown status
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NahariyaIsraelUnknown status
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Petah TikvaIsraelUnknown status
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Ramat GanIsraelUnknown status
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AhmedabadIndiaUnknown status
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BangaloreIndiaUnknown status
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ChennaiIndiaUnknown status
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GūrgaonIndiaUnknown status
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KaramsadIndiaUnknown status
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New DelhiIndiaUnknown status
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Bunkyō CityJapanUnknown status
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FukushimaJapanUnknown status
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Habikino-shiJapanUnknown status
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Hirosaki-shiJapanUnknown status
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Iizuka-shiJapanUnknown status
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Iwakuni-shiJapanUnknown status
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KanazawaJapanUnknown status
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Kishiwada-shiJapanUnknown status
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KobeJapanUnknown status
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Kurume-shiJapanUnknown status
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KyotoJapanUnknown status
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Mitaka-shiJapanUnknown status
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Nagaoka-shiJapanUnknown status
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NagoyaJapanUnknown status
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NiigataJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SagaJapanUnknown status
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Sagamihara-shiJapanUnknown status
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SakaishiJapanUnknown status
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SendaiJapanUnknown status
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TokushimaJapanUnknown status
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Ube-shiJapanUnknown status
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WakayamaJapanUnknown status
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YokohamaJapanUnknown status
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DaeguSouth KoreaUnknown status
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Hwasun-gunSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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AcapulcoMexicoUnknown status
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AguascalientesMexicoUnknown status
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MéridaMexicoUnknown status
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MéxicoMexicoUnknown status
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MonterreyMexicoUnknown status
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Kuala LumpurMalaysiaUnknown status
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KuantanMalaysiaUnknown status
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KuchingMalaysiaUnknown status
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ArequipaPeruUnknown status
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BellavistaPeruUnknown status
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LimaPeruUnknown status
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Baguio CityPhilippinesUnknown status
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CebuPhilippinesUnknown status
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Las PiñasPhilippinesUnknown status
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ManilaPhilippinesUnknown status
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Quezon CityPhilippinesUnknown status
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BydgoszczPolandUnknown status
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KielcePolandUnknown status
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KrakowPolandUnknown status
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LodzPolandUnknown status
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MrozyPolandUnknown status
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OlsztynPolandUnknown status
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PoznanPolandUnknown status
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WarsawPolandUnknown status
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Wodzisław ŚląskiPolandUnknown status
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AmadoraPortugalUnknown status
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LisbonPortugalUnknown status
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PortoPortugalUnknown status
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DohaQatarUnknown status
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SuceavaRomaniaUnknown status
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MoscowRussiaUnknown status
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OmskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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DammamSaudi ArabiaUnknown status
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RiyadhSaudi ArabiaUnknown status
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EskilstunaSwedenUnknown status
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LinköpingSwedenUnknown status
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StockholmSwedenUnknown status
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UppsalaSwedenUnknown status
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SingaporeSingaporeUnknown status
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ChernivtsіUkraineUnknown status
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DniproUkraineUnknown status
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Ivano-FrankivskUkraineUnknown status
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Kapitanivka VillageUkraineUnknown status
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Kharkiv RegionUkraineUnknown status
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KirovohradUkraineUnknown status
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KyivUkraineUnknown status
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LiutizhUkraineUnknown status
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LvivUkraineUnknown status
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OdesaUkraineUnknown status
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SumyUkraineUnknown status
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UzhhorodUkraineUnknown status
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VinnytsiaUkraineUnknown status
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AlbuquerqueUnited StatesUnknown status
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AnaheimUnited StatesUnknown status
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CantonUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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East SetauketUnited StatesUnknown status
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Florham ParkUnited StatesUnknown status
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Fresh MeadowsUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PoughkeepsieUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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Santa RosaUnited StatesUnknown status
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Stony BrookUnited StatesUnknown status
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ZanesvilleUnited StatesUnknown status
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AdanaTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status
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IzmirTurkey (Türkiye)Unknown status

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