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NCT04303780CompletedPhase 3

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Source: ClinicalTrials.gov · Last updated 22 Jul 2026

Brief summary (registry, in English)

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
345 (actual)
First submitted
5 Mar 2020
Start date
4 Jun 2020
Primary completion date
2 Aug 2022
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT04303780
EU CT number
2023-508214-42-00
EudraCT number
2019-003582-18

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 345
  • From 4 Jun 2020 to the primary completion date, 2 Aug 2022
  • 214 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.

Other illness

  • Myocardial infarction within 6 months of study day 1
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication

Other

  • Active brain metastases

Who the study is looking for

  • Men or women greater than or equal to 18 years old.
  • ECOG ≤ 1
  • Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

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

Full criteria on ClinicalTrials.gov

Sites (214)

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

SiteCityCountrySite status
Blacktown Hospital
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BlacktownAustraliaUnknown status
Chris Obrien Lifehouse
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CamperdownAustraliaUnknown status
Prince Charles Hospital
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ChermsideAustraliaUnknown status
Monash Medical Centre
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ClaytonAustraliaUnknown status
St George Hospital
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KogarahAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
St John of God Healthcare
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SubiacoAustraliaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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BrusselsBelgiumUnknown status
Institute Jules Bordet
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BrusselsBelgiumUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumUnknown status
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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LeuvenBelgiumUnknown status
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumUnknown status
AZ Delta (Campus Rumbeke)
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RoeselareBelgiumUnknown status
Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas
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Sint-NiklaasBelgiumUnknown status
Hospital de Caridade de Ijui
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IjuíBrazilUnknown status
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul
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Porto AlegreBrazilUnknown status
Instituto Coi
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Rio de JaneiroBrazilUnknown status
Centro de Tratamento de Tumores Botafogo
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Rio de JaneiroBrazilUnknown status
Hospital de Base de Sao Jose do Rio Preto
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São José Do Rio PretoBrazilUnknown status
Fundacao Antonio Prudente - Hospital A C Camargo
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São PauloBrazilUnknown status
Oncologia Rede D´Or
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São PauloBrazilUnknown status
Hospital Israelita Albert Einstein
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São PauloBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Beneficencia Portuguesa de Sao Paulo
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São PauloBrazilUnknown status
Tom Baker Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Juravinski Cancer Centre
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HamiltonCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame
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MontrealCanadaUnknown status
The Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Universitaetsspital Basel
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BaselSwitzerlandUnknown status
Inselspital Bern
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BernSwitzerlandUnknown status
Hôpitaux universitaires de Genève
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GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire Vaudois
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LausanneSwitzerlandUnknown status
Kantonsspital Winterthur
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WinterthurSwitzerlandUnknown status
Universitaetsspital Zuerich
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ZurichSwitzerlandUnknown status
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyCompleted
Asklepios Fachkliniken Muenchen-Gauting
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GautingGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
POIS Sachsen GmbH
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LeipzigGermanyCompleted
Pius Hospital Oldenburg
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OldenburgGermanyCompleted
Herlev og Gentofte Hospital
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HerlevDenmarkUnknown status
Rigshospitalet
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KøbenhavnDenmarkUnknown status
Odense Universitetshospital
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Odense CDenmarkUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Helsingin Yliopistollinen Keskussairaala
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HelsinkiFinlandUnknown status
Docrates Syopasairaala
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HelsinkiFinlandUnknown status
Oulu University Hospital
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OuluFinlandUnknown status
Turku University Hospital
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TurkuFinlandUnknown status
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
Institut Curie
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ParisFranceCompleted
Hopital Tenon
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Paris Cedex 20FranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
Royal Marsden Hospital
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LondonUnited KingdomUnknown status
Sarah Cannon Research Institute UK
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LondonUnited KingdomUnknown status
Christie Hospital
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ManchesterUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
General University Hospital Of Patras
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PatrasGreeceCompleted
Theageneio Cancer Hospital
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ThessalonikiGreeceCompleted
Semmelweis Egyetem
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BudapestHungaryUnknown status
Orszagos Koranyi Pulmonologiai Intezet
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BudapestHungaryUnknown status
Veszprém Megyei Tudőgyógyintézet
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FarkasgyepüHungaryUnknown status
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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GyulaHungaryUnknown status
Somogy Megyei Kaposi Mór Oktató Kórház
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KaposvárHungaryUnknown status
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
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MiskolcHungaryUnknown status
Fejér Megyei Szent György Egyetemi Oktató Kórház
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SzékesfehérvárHungaryUnknown status
Szent Borbála Kórház
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TatabányaHungaryUnknown status
Tudogyogyintezet Torokbalint
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TörökbálintHungaryUnknown status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Hyogo Cancer Center
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Akashi-shiJapanUnknown status
Juntendo University Hospital
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Bunkyo-kuJapanUnknown status
Chiba Cancer Center
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ChibaJapanUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Cancer Center
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FukuokaJapanUnknown status
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
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Fukuyama-shiJapanUnknown status
Osaka Habikino Medical Center
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Habikino-shiJapanUnknown status
National Hospital Organization Himeji Medical Center
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Himeji-shiJapanUnknown status
Kansai Medical University Hospital
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Hirakata-shiJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Itami City Hospital
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Itami-shiJapanUnknown status
National Hospital Organization Iwakuni Clinical Center
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Iwakuni-shiJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
St Marianna University School of Medicine Hospital
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Kawasaki-shiJapanUnknown status
Saitama Cancer Center
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Kitaadachi-gunJapanUnknown status
Hospital of the University of Occupational and Environmental Health
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Kitakyushu-shiJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
Cancer Institute Hospital of Japanese Foundation for Cancer Research
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Koto-kuJapanUnknown status
Kyoto University Hospital
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KyotoJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
Nagoya University Hospital
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NagoyaJapanUnknown status
Miyagi Cancer Center
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Natori-shiJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
Osaka City General Hospital
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OsakaJapanUnknown status
Kindai University Hospital
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Osakasayama-ShiJapanUnknown status
Shiga University of Medical Science Hospital
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ŌtsuJapanUnknown status
Saga-ken Medical Centre Koseikan
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SagaJapanUnknown status
Kitasato University Hospital
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Sagamihara-shiJapanUnknown status
National Hospital Organization Kinki-Chuo Chest Medical Center
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Sakai-ShiJapanUnknown status
National Hospital Organization Hokkaido Cancer Center
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SapporoJapanUnknown status
Sendai Kousei Hospital
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SendaiJapanUnknown status
National Hospital Organization Yamaguchi-Ube Medical Center
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Ube-shiJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
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YokohamaJapanUnknown status
Tottori University Hospital
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Yonago-shiJapanUnknown status
Chungbuk National University Hospital
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Cheongju-si, Chungcheongbuk-doSouth KoreaUnknown status
National Cancer Center
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Goyang-si Gyeonggi-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-si, Gyeonggi-doSouth KoreaUnknown status
Cha Bundang Medical Center, Cha University
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Seongnam-si, Gyeonggi-doSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
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AmsterdamNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
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LisbonPortugalUnknown status
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Matosinhos MunicipalityPortugalUnknown status
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
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PortoPortugalUnknown status
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
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PortoPortugalUnknown status
Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao
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PortoPortugalUnknown status
Clinical hospital 2, Group of companies medsi
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MoscowRussiaUnknown status
LLC Tonus
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Nizhny NovgorodRussiaUnknown status
Omsk Regional Clinical Oncology Dispensary
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OmskRussiaUnknown status
FSBI Scientific and Research Oncology Institute named after N N Petrov
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Saint PetersburgRussiaUnknown status
Saint Petersburg scientifical practical center of specialized kinds of medical care oncological
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Saint PetersburgRussiaUnknown status
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenCompleted
Veterans General Hospital - Taichung
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
United States Oncology Regulatory Affairs Corporate Office
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AlbanyUnited StatesUnknown status
New York Oncology Hematology PC
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AlbanyUnited StatesUnknown status
Pacific Cancer Medical Center INC
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AnaheimUnited StatesUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Northside Hospital, Incorporated
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AtlantaUnited StatesUnknown status
Texas Oncology - Bedford
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BedfordUnited StatesUnknown status
Charleston Oncology
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CharlestonUnited StatesUnknown status
Tennessee Oncology, PLLC
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ChattanoogaUnited StatesUnknown status
Oncology Hematology Care, Inc
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CincinnatiUnited StatesUnknown status
Maryland Oncology Hematology PA
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ClintonUnited StatesUnknown status
Texas Oncology Baylor
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DallasUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Rocky Mountain Cancer Centers
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DenverUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
Virginia Cancer Specialists PC
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FairfaxUnited StatesUnknown status
Summit Medical Group
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Florham ParkUnited StatesUnknown status
Florida Cancer Specialists - Fort Myers
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Fort MyersUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology
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Fort WayneUnited StatesUnknown status
The Center for Cancer and Blood Disorders
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Fort WorthUnited StatesUnknown status
Center for Oncology Clinical Trials
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Grand RapidsUnited StatesUnknown status
Saint Francis Hospital, Inc
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GreenvilleUnited StatesUnknown status
Valley Cancer Associates
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HarlingenUnited StatesUnknown status
Memorial Regional Hospital
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HollywoodUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
US Oncology Research Investigational Products Center
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IrvingUnited StatesUnknown status
HCA Midwest Health Kansas City
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Kansas CityUnited StatesUnknown status
Tennessee Cancer Specialists
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KnoxvilleUnited StatesUnknown status
Northwell Health Monter Cancer Center
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Lake SuccessUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Pacific Shores Medical Group Long Beach
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Long BeachUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
New York Cancer and Blood Specialists
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LowellUnited StatesUnknown status
Minnesota Oncology Hematology PA
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MinneapolisUnited StatesUnknown status
Intermountain Medical Center
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MurrayUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
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NewarkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
Affiliated Oncologists, LLC
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North ChicagoUnited StatesUnknown status
Danbury Hospital
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NorwalkUnited StatesUnknown status
Northwest Cancer Specialists - Vancouver
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PortlandUnited StatesUnknown status
University of California at Davis Medical Center
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SacramentoUnited StatesUnknown status
Ridley-Tree Cancer Center
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Santa BarbaraUnited StatesUnknown status
Willis-Knighton Cancer Center
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ShreveportUnited StatesUnknown status
University of California San Francisco Mission Hall
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StanfordUnited StatesUnknown status
Florida Cancer Specialists Research North
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St. PetersburgUnited StatesUnknown status
Florida Cancer Specialists Research Panhandle
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TallahasseeUnited StatesUnknown status
James J Peters VA Medical Center
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The BronxUnited StatesUnknown status
Montefiore Einstein Center for Cancer Care
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The BronxUnited StatesUnknown status
Harbor University of California Los Angeles Medical Center
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TorranceUnited StatesUnknown status
Hope Cancer Center
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TylerUnited StatesUnknown status
Washington Cancer Institute at MedStar Washington Hospital
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Washington D.C.United StatesUnknown status
Wake Forest Baptist Health
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Winston-SalemUnited StatesUnknown status

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