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NCT04988295Active, not recruitingPhase 3

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
776 (actual)
First submitted
30 Jul 2021
Start date
17 Nov 2021
Primary completion date
10 Jul 2023
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT04988295
EU CT number
2023-506518-33-00
EudraCT number
2021-001825-33

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 776
  • From 17 Nov 2021 to the primary completion date, 10 Jul 2023
  • 220 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
  • Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
  • Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Other illness

  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Other

  • Participant with symptomatic or progressive brain metastases
  • Participant has known small cell transformation

Who the study is looking for

  • Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
  • A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
  • Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement)
  • A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
  • Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

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

Full criteria on ClinicalTrials.gov

Sites (220)

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

SiteCityCountrySite status
CINME Centro de Investigaciones Metabolicas
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CabaArgentinaUnknown status
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
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CABAArgentinaUnknown status
IADT Instituto Argentino de Diagnostico y Tratamiento
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CABAArgentinaUnknown status
Centro Medico Fleischer
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CABAArgentinaUnknown status
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaUnknown status
Hospital Privado Universitario de Córdoba
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CórdobaArgentinaUnknown status
Hospital Privado de la Comunidad
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Mar del PlataArgentinaUnknown status
Clínica Viedma
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ViedmaArgentinaUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
UMHAT Sofiamed OOD
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SofiyaBulgariaActive, not recruiting
Cetus Oncologia
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Belo HorizonteBrazilUnknown status
CIONC-Centro Integrado de Oncologia de Curitiba
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CuritibaBrazilUnknown status
Ynova Pesquisa Clinica
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FlorianópolisBrazilUnknown status
Fundacao Sao Francisco Xavier
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IpatingaBrazilUnknown status
UPCO Unidade de Pesquisa Clinica em Oncologia
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PelotasBrazilUnknown status
Associacao Hospitalar Moinhos de Vento
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Porto AlegreBrazilUnknown status
Hospital Ernesto Dornelles
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Porto AlegreBrazilUnknown status
Instituto D Or de Pesquisa e Ensino IDOR
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Rio de JaneiroBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de JaneiroBrazilUnknown status
Nucleo de Oncologia da Bahia
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SalvadorBrazilUnknown status
IDOR - Regional Bahia
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SalvadorBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Hospital Alemão Oswaldo Cruz
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Hospital Paulistano
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São PauloBrazilUnknown status
Hospital Nove de Julho
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São PauloBrazilUnknown status
IDOR - Regional Sao Paulo
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São PauloBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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SorocabaBrazilUnknown status
COT - Centro Oncologico do Triangulo S.A
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UberlândiaBrazilUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
British Columbia Cancer Agency
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VancouverCanadaUnknown status
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
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BeijingChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Chinese PLA General Hospital
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BeijingChinaUnknown status
Beijing chest hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Hunan Cancer hospital 1
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Southwest Hospital
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ChongqingChinaUnknown status
Daping Hospital Army Characteristic Medical Center
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ChongqingChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Second Affiliated Hospital, School of Medicine, Zhejiang University
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Taizhou Hospital of Zhejiang Province
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LinhaiChinaUnknown status
Affiliated Hospital of North Sichuan Medical College
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NanchongChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Cancer Hospital Chinese Academy of Medical Sciences
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ShenzhenChinaUnknown status
Shenzhen university General Hospital
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ShenzhenChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Weifang People's Hospital
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WeifangChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Nemocnice AGEL Ostrava - Vitkovice a.s.
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OstravaCzechiaCompleted
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Institut Curie
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
Velindre Hospital
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CardiffUnited KingdomUnknown status
Edinburgh Cancer Centre Western General
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EdinburghUnited KingdomUnknown status
The Royal Marsden NHS Trust
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LondonUnited KingdomUnknown status
Guys and St Thomas NHS Foundation Trust
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LondonUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Soroka University Medical Center
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BeershebaIsraelUnknown status
Rambam Health Corporation
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Health Care Global Enterprises pvt Ltd
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BangaloreIndiaUnknown status
Artemis Hospital
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GurugramIndiaUnknown status
Tata Medical Center
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KolkataIndiaUnknown status
Tata Memorial Hospital
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MumbaiIndiaUnknown status
HCG Manavta Cancer Centre
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NashikIndiaUnknown status
Rajiv Gandhi Cancer Institute And Research Centre
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New DelhiIndiaUnknown status
Noble Hospital Pvt Ltd
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PuneIndiaUnknown status
Bhaktivedanta Hospital & Research Institute
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ThaneIndiaUnknown status
Centro di Riferimento Oncologico di Aviano
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AvianoItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
European Institute Of Oncology S.r.l.
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MilanItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
National Hospital Organization Shibukawa Medical Center
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GunmaJapanUnknown status
Hyogo Cancer Center
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HyōgoJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
National Hospital Organization Nagoya Medical Center
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NagoyaJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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TokyoJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Ehime University Hospital
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Toon-shiJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
National Hospital Organization Iwakuni Clinical Center
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YamaguchiJapanUnknown status
National Hospital Organization Yamaguchi Ube Medical Center
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YamaguchiJapanUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Gyeonggi-doSouth KoreaUnknown status
CHA Bundang Medical Center, CHA University
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Gyeonggi-doSouth KoreaUnknown status
Gyeongsang National University Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's 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
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Hospital Civil de Guadalajara Fray Antonio Alcalde
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GuadalajaraMexicoUnknown status
CIMOVA, Morals Vargas Centro de Investigación SC
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LeónMexicoUnknown status
Instituto Nacional de Cancerologia
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MéxicoMexicoUnknown status
Health Pharma Professional Research
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MéxicoMexicoUnknown status
Oncologia Integral Satelite
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NaucalpanMexicoUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Tengku Ampuan Afzan
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KuantanMalaysiaUnknown status
Beacon Hospital Sdn Bhd
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Petaling JayaMalaysiaUnknown status
Subang Jaya Medical Centre
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Subang JayaMalaysiaUnknown status
Mount Miriam Cancer Hospital
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Tanjung BungahMalaysiaUnknown status
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Ziekenhuis St Jansdal
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HarderwijkNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandActive, not recruiting
Med Polonia Sp z o.o.
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Pan American Center for Oncology Trials LLC
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Rio PiedrasPuerto RicoUnknown status
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
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LisbonPortugalCompleted
Hospital Beatriz Ângelo
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LouresPortugalCompleted
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalCompleted
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalCompleted
City Clinical Hospital #1
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Nal'chikRussiaUnknown status
Llc, Eurocityclinic
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Saint PetersburgRussiaUnknown status
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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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
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TaipeiTaiwanUnknown status
University Cancer And Blood Center LLC
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AthensUnited StatesUnknown status
University of Vermont Medical Center
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BurlingtonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
TriHealth Network
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CincinnatiUnited StatesUnknown status
Rocky Mountain Cancer Centers
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Colorado SpringsUnited StatesUnknown status
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesUnknown status
Texas Oncology-Medical City Dallas
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DallasUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Astera Cancer Care
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East BrunswickUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
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Fort LauderdaleUnited StatesUnknown status
Nebraska Cancer Specialists
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Grand IslandUnited StatesUnknown status
Texas Oncology
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GrapevineUnited StatesUnknown status
Alliance Cancer Specialists
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HorshamUnited StatesUnknown status
Oncology Consultants Texas
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HoustonUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Texas Oncology - Northeast
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LongviewUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Baptist Cancer Center
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MemphisUnited StatesUnknown status
Southern Cancer Center, PC
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MobileUnited StatesUnknown status
University of California Irvine
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OrangeUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Kaiser Permanente Northwest
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PortlandUnited StatesUnknown status
NorthWest Medical Specialties, PLLC
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PuyallupUnited StatesUnknown status
Arizona Oncology Associates
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TucsonUnited StatesUnknown status
Compass Oncology
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VancouverUnited StatesUnknown status
Blue Ridge Cancer Care
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WythevilleUnited StatesUnknown status
Adana City Hospital
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AdanaTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi
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Gazi University Hospital
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Trakya University Medical Faculty
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Bakirkoy Training and Research Hospital
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Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
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Istanbul University Cerrahpasa Medical Faculty
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Medipol Mega University Hospital
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Medical Point
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