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NCT05722015Active, not recruitingPhase 3

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
377 (actual)
First submitted
27 Jan 2023
Start date
14 Feb 2023
Primary completion date
12 Jul 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT05722015
EU CT number
2022-501506-36-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 377
  • From 14 Feb 2023 to the primary completion date, 12 Jul 2024
  • 109 sites in 16 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

  • Has received prior systemic anticancer therapy for metastatic NSCLC
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
  • Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
  • Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Other illness

  • Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has a history of human immunodeficiency virus (HIV) infection
  • Has a history of Hepatitis B or C
  • Has a history of allogenic tissue/solid organ transplant

Who the study is looking for

  • Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
  • Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
  • Has a life expectancy of at least 3 months

Criteria the registry did not label

  • The key inclusion and exclusion criteria include but are not limited to the following:

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

Full criteria on ClinicalTrials.gov

Sites (109)

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

SiteCityCountrySite status
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Instituto Alexander Fleming ( Site 1008)
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Buenos AiresArgentinaUnknown status
Clinica Adventista Belgrano-Oncology ( Site 1004)
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Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Hospital Italiano de Córdoba ( Site 1000)
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Sanatorio Parque ( Site 1003)
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RosarioArgentinaUnknown status
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)
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FortalezaBrazilUnknown status
Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)
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JoinvilleBrazilUnknown status
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)
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Porto AlegreBrazilUnknown status
Hospital de Cancer de Pernambuco ( Site 1107)
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RecifeBrazilUnknown status
A. C. Camargo Cancer Center ( Site 1106)
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São PauloBrazilUnknown status
IC La Serena Research ( Site 1207)
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La SerenaChileUnknown status
Bradfordhill-Clinical Area ( Site 1202)
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SantiagoChileUnknown status
Instituto Nacional del Cancer-CR Investigación ( Site 1211)
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SantiagoChileUnknown status
Oncovida ( Site 1209)
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SantiagoChileUnknown status
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)
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SantiagoChileUnknown status
FALP-UIDO ( Site 1203)
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SantiagoChileUnknown status
Oncocentro Valdivia ( Site 1201)
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ValdiviaChileUnknown status
Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)
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BeijingChinaUnknown status
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)
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BeijingChinaUnknown status
Beijing Chest Hospital,Capital Medical University ( Site 4511)
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BeijingChinaUnknown status
Fujian Provincial Cancer Hospital ( Site 4517)
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FuzhouChinaUnknown status
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519)
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)
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HangzhouChinaUnknown status
Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)
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HefeiChinaUnknown status
Jiangmen Center Hospital ( Site 4509)
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JiangmenChinaUnknown status
Taizhou Hospital of Zhejiang Province ( Site 4508)
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LinhaiChinaUnknown status
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)
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NanchangChinaUnknown status
Fudan University Shanghai Cancer Center-Oncology ( Site 4512)
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ShanghaiChinaUnknown status
ShenZhen People's Hospital ( Site 4504)
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ShenzhenChinaUnknown status
Shanxi Cancer Hospital ( Site 4521)
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TaiyuanChinaUnknown status
Tianjin Chest Hospital ( Site 4518)
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TianjinChinaUnknown status
Chongqing University Three Gorges Hospital ( Site 4516)
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WanzhouChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502)
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WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)
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Xi'anChinaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Intercommunal De Cornouaille
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Quimper CedexFranceCompleted
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceCompleted
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)
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Guatemala CityGuatemalaUnknown status
MEDI-K ( Site 1403)
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Guatemala CityGuatemalaUnknown status
Centro Regional de Sub Especialidades Médicas SA ( Site 1401)
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QuetzaltenangoGuatemalaUnknown status
Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)
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QuetzaltenangoGuatemalaUnknown status
Semmelweis University
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Budapest VIIIHungaryActive, not recruiting
Koranyi National Institute For Pulmonology
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Budapest XIIHungaryActive, not recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryActive, not recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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SzolnokHungaryActive, not recruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryActive, not recruiting
Juntendo University Hospital ( Site 4413)
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Bunkyo-kuJapanUnknown status
National Hospital Organization Kyushu Medical Center ( Site 4411)
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Cancer Center ( Site 4410)
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FukuokaJapanUnknown status
Kansai Medical University Hospital ( Site 4408)
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HirakataJapanUnknown status
Saitama Prefectural Cancer Center ( Site 4402)
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Kitaadachi-gunJapanUnknown status
Kurashiki Central Hospital ( Site 4409)
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KurashikiJapanUnknown status
Kurume University Hospital ( Site 4412)
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KurumeJapanUnknown status
Miyagi Cancer Center ( Site 4401)
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Natori-shiJapanUnknown status
Osaka International Cancer Institute ( Site 4407)
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OsakaJapanUnknown status
Gunma Prefectural Cancer Center ( Site 4416)
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ŌtaJapanUnknown status
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
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SapporoJapanUnknown status
Sendai Kousei Hospital ( Site 4400)
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SendaiJapanUnknown status
Shizuoka Cancer Center ( Site 4405)
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Sunto-gun,JapanUnknown status
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
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TakatsukiJapanUnknown status
Nippon Medical School Hospital ( Site 4403)
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TokyoJapanUnknown status
Fujita Health University Hospital ( Site 4406)
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ToyoakeJapanUnknown status
Tochigi Cancer Center ( Site 4417)
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UtsunomiyaJapanUnknown status
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
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YokohamaJapanUnknown status
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
Coordinator of this site? Confirm its status
CraiovaRomaniaActive, not recruiting
Radiotherapy Center Cluj S.R.L.
Coordinator of this site? Confirm its status
FlorestiRomaniaActive, not recruiting
Oncomed S.R.L.
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TimisoaraRomaniaActive, not recruiting
Division of Medical Oncology, Siriraj H ( Site 4303)
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
Chulalongkorn University ( Site 4301)
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital ( Site 4300)
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Chiang MaiThailandUnknown status
Songklanagarind hospital ( Site 4302)
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SongkhlaThailandUnknown status
Changhua Christian Hospital ( Site 4203)
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ChanghuaTaiwanUnknown status
E-Da hospital ( Site 4208)
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Kaohsiung CityTaiwanUnknown status
Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)
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Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital ( Site 4202)
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TainanTaiwanUnknown status
National Taiwan University Hospital-Oncology ( Site 4204)
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TaipeiTaiwanUnknown status
National Taiwan University Cancer Center (NTUCC) ( Site 4205)
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Taipei CityTaiwanUnknown status
Central Care Cancer Center - Bolivar ( Site 0017)
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BolivarUnited StatesUnknown status
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)
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ChicagoUnited StatesUnknown status
Clermont Oncology Center ( Site 0018)
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ClermontUnited StatesUnknown status
Hattiesburg Clinic Hematology/Oncology ( Site 0008)
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HattiesburgUnited StatesUnknown status
Franciscan Health Lafayette East ( Site 0020)
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LafayetteUnited StatesUnknown status
Mid Florida Hematology and Oncology Center ( Site 0010)
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Orange CityUnited StatesUnknown status
Mercy Health-Paducah Cancer Center ( Site 0006)
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PaducahUnited StatesUnknown status
St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)
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PhoenixUnited StatesUnknown status
Orchard Healthcare Research Inc. ( Site 0011)
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SkokieUnited StatesUnknown status
Cape Town Oncology Trials ( Site 2902)
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Cape TownSouth AfricaUnknown status
The Oncology Centre ( Site 2901)
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DurbanSouth AfricaUnknown status
Medical Oncology Centre of Rosebank ( Site 2907)
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JohannesburgSouth AfricaUnknown status
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)
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Port ElizabethSouth AfricaUnknown status
Steve Biko Academic Hospital-Medical Oncology ( Site 2904)
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PretoriaSouth AfricaUnknown status
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)
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SandtonSouth AfricaUnknown status
Ankara City Hospital-Medical Oncology ( Site 2501)
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AnkaraTurkey (Türkiye)Unknown status
Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)
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AnkaraTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
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IstanbulTurkey (Türkiye)Unknown status
I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)
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IzmirTurkey (Türkiye)Unknown status
Memorial Kayseri Hastanesi ( Site 2500)
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KayseriTurkey (Türkiye)Unknown status
İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)
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MalatyaTurkey (Türkiye)Unknown status

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