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NCT06311721Active, not recruitingPhase 3

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
315 (actual)
First submitted
8 Mar 2024
Start date
9 Sept 2024
Primary completion date
10 Jan 2028
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT06311721
EU CT number
2024-514304-14-00
EudraCT number
2023-508336-57

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 315
  • From 9 Sept 2024 to the primary completion date, 10 Jan 2028
  • 223 sites in 23 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

  • Participant has active central nervous system metastases not previously treated.
  • Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.

Other illness

  • Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
  • Participant has active or known immune-mediated disorders.
  • Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

Who the study is looking for

  • At least 18 years of age.
  • Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
  • Participant has no prior systemic treatment for advanced disease.
  • Measurable disease according to RECIST v1.1.
  • Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
  • Eastern Cooperative Oncology Group performance status score 0 or 1.
  • Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative
  • Have a life expectancy of at least 3 months.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (223)

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

SiteCityCountrySite status
IONC - Instituto Oncologico de Cordoba
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CórdobaArgentinaUnknown status
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaUnknown status
Centro de Investigación Pergamino SA
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PergaminoArgentinaUnknown status
Hospital Provincial del Centenario
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RosarioArgentinaUnknown status
Sanatorio Británico de Rosario
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RosarioArgentinaUnknown status
Fundacion ARS Medica
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San Salvador de JujuyArgentinaUnknown status
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaCompleted
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
Klinik Hietzing
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ViennaAustriaCompleted
Multiprofile Hospital for Active Treatment - Dobrich AD
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DobrichBulgariaRecruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
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SofiaBulgariaRecruiting
UMHAT Sofiamed OOD
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SofiyaBulgariaRecruiting
Fundação Pio XII - Hospital de Câncer de Barretos
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BarretosBrazilUnknown status
Cetus Oncologia S.A. Unidade Belo Horizonte
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Belo HorizonteBrazilUnknown status
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
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Belo HorizonteBrazilUnknown status
Hospital Tacchini
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Bento GonçalvesBrazilUnknown status
OC Oncoclinicas Oncovida
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BrasíliaBrazilUnknown status
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
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Cachoeiro de ItapemirimBrazilUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Hospital Nossa Senhora das Gracas
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CanoasBrazilUnknown status
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
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ChapecóBrazilUnknown status
CIONC-Centro Integrado de Oncologia de Curitiba
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CuritibaBrazilUnknown status
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
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CuritibaBrazilUnknown status
CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
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FlorianópolisBrazilUnknown status
Crio - Centro Regional Integrado de Oncologia
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FortalezaBrazilUnknown status
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
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IjuíBrazilUnknown status
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
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IpatingaBrazilUnknown status
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
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JoinvilleBrazilUnknown status
Hospital Bruno Born
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LajeadoBrazilUnknown status
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
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LondrinaBrazilUnknown status
Centro Oncologico Mogi das Cruzes
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Mogi das CruzesBrazilUnknown status
Liga Contra o Cancer
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NatalBrazilUnknown status
Hospital da Cidade de Passo Fundo - HCPF
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Passo FundoBrazilUnknown status
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
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PelotasBrazilUnknown status
Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
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Porto AlegreBrazilUnknown status
Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
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Porto AlegreBrazilUnknown status
Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
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Porto Alegre Rio Grande Do SulBrazilUnknown status
Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
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Ribeirão PretoBrazilUnknown status
Instituto Americas - Ensino, Pesquisa e Inovacao
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Rio de JaneiroBrazilUnknown status
Instituto Nacional de Câncer - INCA
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Rio de JaneiroBrazilUnknown status
Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
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Rio de Janeiro - RJBrazilUnknown status
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
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SalvadorBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino - Hospital Sao Rafael
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SalvadorBrazilUnknown status
Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
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São José do Rio PretoBrazilUnknown status
Hospital Alemao Oswaldo Cruz (HAOC)
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São PauloBrazilUnknown status
Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
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São PauloBrazilUnknown status
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
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VitóriaBrazilUnknown status
CDIEM - Centro de Investigacion y Especialidades Medicas
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ProvidenciaChileUnknown status
Centro de Oncologa de Precisin
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Region MetropolitanaChileUnknown status
Icegclinic Research and Care
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SantiagoChileUnknown status
Clinica Santa Maria
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SantiagoChileUnknown status
K2 Oncology
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SantiagoChileUnknown status
Oncocentro Apys
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Viña del MarChileUnknown status
Centro de Investigaciones Clinicas Vina del Mar Ltda.
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Viña del MarChileUnknown status
Klinikum St. Marien Amberg
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AmbergGermanyCompleted
Klinikum Aschaffenburg-Alzenau gGmbH
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AschaffenburgGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
Justus-Liebig-Universitaet Giessen
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GiessenGermanyCompleted
Dr. Vehling-Kaiser MVZ GmbH
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LandshutGermanyCompleted
Onkologie UnterEms
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LeerGermanyCompleted
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
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NeumuensterGermanyCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Quirónsalud Barcelona
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BarcelonaSpainRecruiting
Micancer Center S.L.P.
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BarcelonaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
Instituto Multidisciplinar De Oncologia S.A.
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Quironsalud Malaga
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MálagaSpainRecruiting
Consorci Sanitari Del Maresme
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MataroSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Hospital Universitario Virgen De Valme
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SevillaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Quironsalud Valencia
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceRecruiting
Hopital Europeen Marseille
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MarseilleFranceRecruiting
Centre De Cancerologue Du Grand Montpellier
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MontpellierFranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
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ToulonFranceRecruiting
Hopitaux Prives De Metz
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VantouxFranceRecruiting
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
High Technology Hospital Medcenter LTD
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BatumiGeorgiaUnknown status
New Hospitals
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TbilisiGeorgiaUnknown status
Llc Todua Clinic
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TbilisiGeorgiaUnknown status
Israel- Georgian Medical Research Clinic Healthycore
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TbilisiGeorgiaUnknown status
TIM - Tbilisi Institute of Medicine
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TbilisiGeorgiaUnknown status
Medulla - Clinics And Medical Centers
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TbilisiGeorgiaUnknown status
Azienda Socio-Sanitaria Territoriale di Cremona
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CremonaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Sanitaria Locale Napoli 1 Centro
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NaplesItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
San Camillo Forlanini Hospital
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RomeItalyRecruiting
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
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SondrioItalyRecruiting
Azienda Ospedaliera S Maria Di Terni
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TerniItalyRecruiting
Hyogo Prefectural Amagasaki General Medical Center
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AmagasakiJapanUnknown status
Asahikawa Medical University Hospital
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AsahikawaJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Chugoku Central Hospital
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FukuyamaJapanUnknown status
Funabashi Municipal Medical Center
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Funabashi-shiJapanUnknown status
Hamamatsu Medical Center
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HamamatsuJapanUnknown status
Seirei Hamamatsu General Hospital
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HamamatsuJapanUnknown status
Hiroshima Prefectural Hospital
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HiroshimaJapanUnknown status
Aso Iizuka Hospital
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Iizuka-shiJapanUnknown status
Kawaguchi Municipal Medical Center
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Kawaguchi-shiJapanUnknown status
Nippon Medical School Musashikosugi Hospital
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Kawasaki-shiJapanUnknown status
Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
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KumamotoJapanUnknown status
Japanese Red Cross Maebashi Hospital
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MaebashiJapanUnknown status
Shinshu University Hospital
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MatsumotoJapanUnknown status
Miyazaki Prefectural Miyazaki Hospital
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MiyazakiJapanUnknown status
Japan Community Healthcare Organization Chukyo Hospital
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NagoyaJapanUnknown status
Ome Medical Center
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Ome-shiJapanUnknown status
Osaki Citizen Hospital
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ŌsakiJapanUnknown status
NHO Kinki-Chuo Chest Medical Center
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SakaiJapanUnknown status
Yokohama City University Hospital
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YokohamaJapanUnknown status
Yokosuka Kyosai Hospital
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YokosukaJapanUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Hospital Sultanah Bahiyah
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Alor StarMalaysiaUnknown status
Hospital Canselor Tuanku Muhriz UKM
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CherasMalaysiaUnknown status
Raja Perempuan Zainab II Hospital
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Kota BharuMalaysiaUnknown status
University of Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Clinic Vallesur Arequipa
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ArequipaPeruUnknown status
Centro Medico Monte Carmelo
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ArequipaPeruUnknown status
Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal
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BellavistaPeruUnknown status
Hospital III Goyeneche
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CercadoPeruUnknown status
Hospital de Apoyo Maria Auxiliadora
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LimaPeruUnknown status
Instituto Nacional De Enfermedades Neoplasicas
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SurquilloPeruUnknown status
Clnica San Antonio
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TrujilloPeruUnknown status
Riverside Medical Center Inc
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Bacolod CityPhilippinesUnknown status
Cebu Doctors University Hospital
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Cebu CityPhilippinesUnknown status
Perpetual Succour Hospital
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Cebu CityPhilippinesUnknown status
Chong Hua Hospital
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Cebu CityPhilippinesUnknown status
Davao Doctors Hospital
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Davao CityPhilippinesUnknown status
West Visayas State University Medical Center
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Iloilo CityPhilippinesUnknown status
St. Paul's Hospital of Iloilo, Inc.
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Iloilo CityPhilippinesUnknown status
Philippine General Hospital
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ManilaPhilippinesUnknown status
Asian Hospital And Medical Center
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MuntinlupaPhilippinesUnknown status
Veterans Memorial Medical Center
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Quezon CityPhilippinesUnknown status
St. Lukes Medical Center
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Quezon CityPhilippinesUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandRecruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
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LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandRecruiting
Med Polonia Sp z o.o.
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PoznanPolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandRecruiting
Clincial Centre of Serbia
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BelgradeSerbiaUnknown status
Institute for Pulmonary Diseases of Vojvodina
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KamenitzSerbiaUnknown status
University Clinical Centre of Kragujevac
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KragujevacSerbiaUnknown status
King Chulalongkorn Memorial Hospital, Chulalongkom University
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BangkokThailandUnknown status
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
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BangkokThailandUnknown status
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
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BangkoknoiThailandUnknown status
Prince Of Songkla Hospital, Prince Of Songkhla University
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Hat YaiThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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MuangThailandUnknown status
Naresuan University Hospital
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MuangThailandUnknown status
Chiangrai Prachanukroh Hospital
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MuangThailandUnknown status
Chulabhorn Hospital
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Talat Bang KhenThailandUnknown status
Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
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Chiayi CityTaiwanUnknown status
National Taiwan University Hospital Yun-Lin Branch
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DouliuTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CountyTaiwanUnknown status
Tri-Service General Hospital
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NeihuTaiwanUnknown status
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
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New Taipei CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital NTUH
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Accellacare of McFarland
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AmesUnited StatesUnknown status
Precision NextGen Oncology and Research Center
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Beverly HillsUnited StatesUnknown status
Gabrail Cancer Center Research
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CantonUnited StatesUnknown status
TOI Clinical Research
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CerritosUnited StatesUnknown status
Detroit Clinical Research Center, PC
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Farmington HillsUnited StatesUnknown status
Millennium Oncology - Hollywood
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HollywoodUnited StatesUnknown status
Millennium Research and Clinical Development, LLC
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HoustonUnited StatesUnknown status
Cancer and Blood Specialty Clinic (CBSC)
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Los AlamitosUnited StatesUnknown status
Valkyrie Clinical Trials
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Los AngelesUnited StatesUnknown status
Accellacare Duly
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PlainfieldUnited StatesUnknown status
Texas Oncology, P.A
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San AntonioUnited StatesUnknown status
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
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ShirleyUnited StatesUnknown status
BRCR Medical Center Inc.
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TamaracUnited StatesUnknown status
PIH Health Hospital
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WhittierUnited StatesUnknown status
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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WythevilleUnited StatesUnknown status
Dr W M Szpak Inc - Rainbow Oncology
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Athlone ParkSouth AfricaUnknown status
GVI Oncology, Langenhoven Drive Oncology Centre
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Port ElizabethSouth AfricaUnknown status
Life Wilgers Hospital Wilgers Oncology Centre
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PretoriaSouth AfricaUnknown status
University of Pretoria and Steve Biko Academic Hospital Complex
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PretoriaSouth AfricaUnknown status
Abraham Oncology
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Richards BaySouth AfricaUnknown status
Adana City Training and Research Hospital
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AdanaTurkey (Türkiye)Unknown status
Medical Park Seyhan Hospital
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AdanaTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ondokuz Mayis University Health Practice and Research Hospital
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AtakumTurkey (Türkiye)Unknown status
Uludag University Medical Faculty
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BursaTurkey (Türkiye)Unknown status
Medical Point Gaziantep Hospital
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GaziantepTurkey (Türkiye)Unknown status
Trakya University Faculty of Medicine
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Istanbul Medeniyet University Medical Faculty
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Bezmialem Foundation University Medical Faculty
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Yeditepe University Kosuyolu Hospital
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Gulhane Training and Research Hospital
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Kocaeli Universitesi Tip Fakultesi
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Necmettin Erbakan University Meram Medical Faculty
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KonyaTurkey (Türkiye)Unknown status
Sakarya Universitesi Tip Fakultesi
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Adana Ortadogu Hospital
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SeyhanTurkey (Türkiye)Unknown status
Namik Kemal Universitesi Hastanesi
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Gazi University Faculty of Medicine
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