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NCT05920356RecruitingPhase 3

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
750 (estimated)
First submitted
23 May 2023
Start date
16 Nov 2023
Primary completion date
30 Jun 2027
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT05920356
EU CT number
2022-501863-41-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 750
  • From 16 Nov 2023 to the primary completion date, 30 Jun 2027
  • 411 sites in 38 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

  • Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
  • Prior therapy with a KRAS G12C inhibitor

Other illness

  • Gastrointestinal (GI) tract disease causing the inability to take oral medication
  • Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina

Other

  • Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
  • Symptomatic (treated or untreated) brain metastases

Who the study is looking for

  • Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
  • No history of systemic anticancer therapy in metastatic/non-curable settings
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (411)

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

SiteCityCountrySite status
Centro Oncologico Korben
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Buenos AiresArgentinaRecruiting
Hospital Británico de Buenos Aires
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CABAArgentinaTerminated
Instituto Alexander Fleming
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Capital FederalArgentinaRecruiting
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AiresArgentinaTerminated
Hospital Italiano de La Plata
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La PlataArgentinaRecruiting
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
Coordinator of this site? Confirm its status
La RiojaArgentinaTerminated
Sanatorio Parque SA
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RosarioArgentinaRecruiting
Fundacion Estudios Clinicos
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RosarioArgentinaRecruiting
Centro de Diagnostico Investigacion y Tratamiento
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SaltaArgentinaRecruiting
Fundacion ARS Medica
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San Salvador de JujuyArgentinaTerminated
Clínica Viedma
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ViedmaArgentinaRecruiting
Burgenlaendische Krankenanstalten GmbH
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EisenstadtAustriaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Klinikum Klagenfurt Am Woerthersee
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Klagenfurt Am WoertherseeAustriaRecruiting
Universitaetsklinikum Krems
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Krems An Der DonauAustriaRecruiting
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaRecruiting
Cancer Research South Australia
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AdelaideAustraliaRecruiting
Campbelltown Hospital
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CampbelltownAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
Nepean Cancer Centre
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KingswoodAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaCompleted
Port Macquarie Base Hospital
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Port MacquarieAustraliaRecruiting
GenesisCare -North Shore Oncology
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St LeonardsAustraliaCompleted
Toowoomba Hospital
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ToowoombaAustraliaRecruiting
Calvary Mater Newcastle Hospital
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WaratahAustraliaTerminated
Princess Alexandra Hospital
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WoolloongabbaAustraliaCompleted
CHIREC
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BrusselsBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
A.Z. Sint-Maarten
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MechelenBelgiumRecruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
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PanagyurishteBulgariaRecruiting
Umhat Sveta Marina - Pleven OOD
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PlevenBulgariaRecruiting
Mbal Za Zhensko Zdrave Nadezhda OOD
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SofiaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
Fundacao pio xII Barretos
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BarretosBrazilRecruiting
Centro de Tratamento Oncologico - Cto
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BelémBrazilTerminated
Cenantron Centro Avançado de Tratamento Oncologico Ltda
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Belo HorizonteBrazilRecruiting
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
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Belo HorizonteBrazilTerminated
Oncoclinicas Onco Vida Distrito Federal
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BrasíliaBrazilTerminated
Hospital Sirio Libanes Brasilia
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BrasíliaBrazilTerminated
Hospital Evangelico de Cachoeiro de Itapemirim
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Cachoeiro de ItapemirimBrazilTerminated
Associação Beneficente de Canoas
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CanoasBrazilTerminated
Clínica de Neoplasias Litoral
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ItajaíBrazilTerminated
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilRecruiting
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul
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Porto AlegreBrazilRecruiting
Hospital Nossa Senhora da Conceição
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Porto AlegreBrazilRecruiting
Instituto Medicina Integral Imip
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RecifeBrazilRecruiting
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilRecruiting
Nucleo de Oncologia da Bahia
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SalvadorBrazilTerminated
Centro de pesquisa em oncologia Hospital Ana Nery
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Santa Cruz do SulBrazilRecruiting
Santa Casa de Misericordia de Santos - Iscms
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SantosBrazilTerminated
Hospital de Base de Sao Jose do Rio Preto
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São José do Rio PretoBrazilTerminated
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
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São PauloBrazilTerminated
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilRecruiting
Beneficencia Portuguesa de Sao Paulo - Bp
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São PauloBrazilTerminated
Fundacao Antonio Prudente
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São PauloBrazilRecruiting
Instituto Cancer Sao Paulo Icesp
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São PauloBrazilRecruiting
Queen Elizabeth II, Health Sciences Centre
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HalifaxCanadaRecruiting
McGill University Health Centre Glen Site
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MontrealCanadaRecruiting
CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal
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MontrealCanadaRecruiting
Institut universitaire de cardiologie et de pneumologie de Québec
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QuébecCanadaTerminated
Allan Blair Cancer Centre
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ReginaCanadaTerminated
Saskatoon Cancer Centre
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SaskatoonCanadaTerminated
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
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TorontoCanadaRecruiting
Kantonsspital Aarau
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AarauSwitzerlandTerminated
Kantonsspital Baden
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BadenSwitzerlandRecruiting
Universitaetsspital Basel
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BaselSwitzerlandTerminated
Universitaetsspital Zuerich
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ZurichSwitzerlandRecruiting
Orlandi Oncologia
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SantiagoChileTerminated
Biocinetic servicios medicos limitada
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SantiagoChileRecruiting
Fundacion Arturo Lopez Perez
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SantiagoChileRecruiting
Centro de Investigacion del Maule
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TalcaChileTerminated
James Lind Centro De Investigacion Del Cancer
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TemucoChileTerminated
Clinica CIDO
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TemucoChileTerminated
Onco Centro Apys
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Viña del MarChileRecruiting
Anyang Tumor Hospital
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AnyangChinaRecruiting
Affiliated Hospital of Hebei University
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BaodingChinaRecruiting
Beijing chest hospital, Capital Medical University
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BeijingChinaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
The First Affiliated Hospital of Bengbu Medical University
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BengbuChinaRecruiting
Jilin Cancer Hospital
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ChangchunChinaRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Xiangya Hospital Central South University
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ChangshaChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
Fujian Provincial Hospital
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FuzhouChinaRecruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
Guangdong Provincial Peoples Hospital
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GuangzhouChinaRecruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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GuangzhouChinaRecruiting
Hainan Cancer Hospital
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HaikouChinaRecruiting
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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HangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaTerminated
Anhui Chest Hospital
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HefeiChinaRecruiting
Cancer Hospital of Shandong First Medical University
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JinanChinaRecruiting
Yunnan Cancer Hospital
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KunmingChinaRecruiting
Gansu Province Cancer Hospital
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LanzhouChinaRecruiting
Linyi Peoples Hospital
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LinyiChinaRecruiting
Liuzhou Peoples Hospital
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LiuzhouChinaRecruiting
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaRecruiting
Jiangxi Cancer Hospital
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NanchangChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
Nanjing First Hospital
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NanjingChinaRecruiting
Guangxi Medical University Cancer Hospital
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NanningChinaRecruiting
Nantong Tumor Hospital
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NantongChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Cancer Hospital of Shantou University Medical College
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ShantouChinaRecruiting
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaRecruiting
Weifang Peoples Hospital
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WeifangChinaRecruiting
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
Zhongshan Hospital Xiamen University
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XiamenChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
Xiangyang Central Hospital
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XiangyangChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Centro Cancerologico del Caribe LTDA CECAC
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BarranquillaColombiaRecruiting
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
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BogotaColombiaRecruiting
Instituto Nacional de Cancerologia
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BogotaColombiaRecruiting
Fundacion cardiovascular de Colombia
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BucaramangaColombiaTerminated
Hemato Oncologos SA
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CaliColombiaRecruiting
Fundacion Colombiana de Cancerologia Clinica Vida
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MedellínColombiaRecruiting
Instituto Medico de Alta Tecnologia sas - Imat sas
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MonteríaColombiaRecruiting
Oncologos del Occidente SAS
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PereiraColombiaRecruiting
Sociedad de Oncologia y Hematologia del Cesar
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ValleduparColombiaTerminated
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Fakultni Nemocnice Plzen
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Plzen 3CzechiaRecruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyRecruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
Klinikverbund Allgaeu gGmbH
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Immenstadt I. AllgäuGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Region Midtjylland
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HerningDenmarkRecruiting
Lillebaelt Hospital
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VejleDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario de Badajoz
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BadajozSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceRecruiting
Besancon University Hospital Center
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Besancon CedexFranceRecruiting
Hôpital Ambroise-Paré
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Boulogne-BillancourtFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceRecruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceRecruiting
Centre Hospitalier Departemental Vendee
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La Roche Sur Yon Cedex 9FranceRecruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceRecruiting
Hôpital Saint Joseph
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MarseilleFranceRecruiting
Centre de Cancérologie du Grand Montpellier
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MontpellierFranceRecruiting
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceRecruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Nîmes
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NîmesFranceRecruiting
Centre Hospitalier Universitaire D Orleans
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Orleans Cedex 2FranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Institut Curie
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ParisFranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph
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Paris Cedex 14FranceRecruiting
Hopital Tenon
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Paris Cedex 20FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre Hospitalier Intercommunal De Cornouaille
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Quimper CedexFranceRecruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
CHU De Rouen
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Rouen CedexFranceRecruiting
Centre Hospitalier Prive Saint Gregoire
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Saint-GrégoireFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Direction Centrale Du Service De Sante Des Armees
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Toulon Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Clinique Pasteur
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Toulouse Cedex 3FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
Hopital Nord-Oest - Villefranche sur Saône
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Villefranche sur SaôneFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomTerminated
Raigmore Hospital
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InvernessUnited KingdomTerminated
Royal Marsden Hospital
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LondonUnited KingdomRecruiting
Mount Vernon Cancer Centre
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NorthwoodUnited KingdomRecruiting
Nottingham City Hospital
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NottinghamUnited KingdomRecruiting
Royal Marsden Hospital
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SuttonUnited KingdomRecruiting
Torbay Hospital
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TorquayUnited KingdomRecruiting
Royal Cornwall Hospital
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TruroUnited KingdomRecruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceRecruiting
251 Air Force General Hospital
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AthensGreeceRecruiting
Alexandra Hospital
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AthensGreeceRecruiting
Athens Medical Center S.A.
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MaroussiGreeceRecruiting
General University Hospital Of Patras
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PatrasGreeceRecruiting
Metropolitan Hospital
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PireasGreeceRecruiting
Metaxa Cancer Center Hospital Of Piraeus
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PireasGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceRecruiting
Queen Mary Hospital, The University of Hong Kong
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Hong KongHong Kong SAR ChinaTerminated
Princess Margaret Hospital
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KowloonHong Kong SAR ChinaTerminated
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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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Oncosalud
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Centrum Pulmonologii I Torakochirurgii W Bystrej
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Pan American Center for Oncology Trials
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Centro Hospitalar Universitario De Lisboa Norte E.P.E.
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Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
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Centrul De Oncologie SF Nectarie S.R.L.
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National University Hospital
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Oncology Consultants, PA
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University of Texas - MD Anderson Cancer Center
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Mercyhealth
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Alliance Cancer Specialists - Media
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Regional One Health
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Regis Clinical Research LLC
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United States Oncology Regulatory Affairs Corporate Office
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Sarah Cannon Research Institute
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Memorial Sloan-Kettering Cancer Center
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Illinois Cancer Specialists
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Vista Oncology Inc PS
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FirstHealth Cancer Center
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Florida Clinical Trials Group Plantation
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Sansum Clinic
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Guthrie Medical Group
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Florida Clinical Trials Group - Tamarac
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