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NCT05388669Active, not recruitingPhase 3

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
418 (actual)
First submitted
19 May 2022
Start date
5 Aug 2022
Primary completion date
3 Jan 2024
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT05388669
EU CT number
2024-512045-16-00
EudraCT number
2022-000525-25

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 418
  • From 5 Aug 2022 to the primary completion date, 3 Jan 2024
  • 152 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

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

Who cannot take part

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

Prior treatment

  • Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
  • Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation

Other illness

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

Lab values

  • Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors

Other

  • Participant has symptomatic or progressive brain metastases
  • Participant has uncontrolled tumor-related pain

Who the study is looking for

  • Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US)
  • Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
  • Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to (\<=) 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement)

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

Full criteria on ClinicalTrials.gov

Sites (152)

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

SiteCityCountrySite status
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
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Buenos AiresArgentinaUnknown status
IADT Instituto Argentino de Diagnostico y Tratamiento
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CABAArgentinaUnknown status
Centro Oncológico Korben
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ChabasArgentinaUnknown status
Sanatorio Allende
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CórdobaArgentinaUnknown status
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaUnknown status
Clínica Viedma
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ViedmaArgentinaUnknown status
Cancer Research SA
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AdelaideAustraliaUnknown status
Chris O'Brien Lifehouse
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CamperdownAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
St John of God Hospital Murdoch
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MurdochAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Fundacao Pio XII
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BarretosBrazilUnknown status
Cetus Oncologia
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Belo HorizonteBrazilUnknown status
Instituto Cionc de Ensino e Pesquisa S/S
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CuritibaBrazilUnknown status
Ynova Pesquisa Clinica
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FlorianópolisBrazilUnknown status
Fundacao Sao Francisco Xavier HMC Unidade de Oncologia
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IpatingaBrazilUnknown status
UPCO Unidade de Pesquisa Clinica em Oncologia
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PelotasBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Instituto D Or de Pesquisa e Ensino IDOR
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Rio de JaneiroBrazilUnknown status
Impar Servicos Hospitalares S/A
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Rio de JaneiroBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Nucleo de Oncologia da Bahia
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SalvadorBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Núcleo de Pesquisa São Camilo
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São PauloBrazilUnknown status
Impar Servicos Hospitalares SA Hospital Nove de Julho
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São PauloBrazilUnknown status
Onco Star SP Oncologia Ltda
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São PauloBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilUnknown status
The Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
Princess Margaret Hospital
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TorontoCanadaUnknown status
Beijing Shijitan Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing chest hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
The First People's Hospital Of Changzhou
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ChangzhouChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Southwest Hospital
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ChongqingChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School 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 First Hospital
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HuizhouChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Liuzhou People's Hospital
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LiuzhouChinaUnknown 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
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Shenzhen university General Hospital
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ShenzhenChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Xiangyang Central Hospital
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XiangyangChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Universitaetsklinikum Giessen und Marburg GmbH
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GiessenGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Imperial College Healthcare
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LondonUnited KingdomUnknown status
Newcastle Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
Rambam Medical Center
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HaifaIsraelUnknown 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
Shaare Zedek Medical Center
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YeruhamIsraelUnknown status
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
National Cancer Center Hospital
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ChūōkuJapanUnknown status
National Hospital Organization Himeji Medical Center
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HimejiJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
Kurashiki Central Hospital
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KurashikiJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Matsusaka Municipal Hospital
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MatsusakaJapanUnknown 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
Hokkaido University Hospital
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SapporoJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Fujita Health University Hospital
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ToyoakeJapanUnknown status
National Hospital Organization Osaka Toneyama Medical Center
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Toyonaka-shiJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
National Hospital Organization Yamaguchi Ube Medical Center
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YamaguchiJapanUnknown status
National Hospital Organization Iwakuni Clinical Center
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YamaguchiJapanUnknown status
National Cancer Center
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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
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Prince Court Medical Centre
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Kuala LumpurMalaysiaUnknown status
Pantai Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Umum Sarawak
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KuchingMalaysiaUnknown status
Beacon Hospital Sdn Bhd
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Petaling JayaMalaysiaUnknown status
Sunway Medical Centre
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Petaling JayaMalaysiaUnknown status
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Hospital Cuf Descobertas S.A.
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LisbonPortugalCompleted
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalCompleted
Phramongkutklao Hospital and Medical College
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Chiang Mai University
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Chiang MaiThailandUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Kung Memorial Hospital
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Kaohsiung CityTaiwanUnknown 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
National Taiwan University Cancer Center
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
Baptist Lynn Cancer Institute
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Boca RatonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
City of Hope - Duarte
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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
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesUnknown status
University of Kansas
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Kansas CityUnited StatesUnknown status
City of Hope Long Beach Elm
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Long BeachUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
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New YorkUnited StatesUnknown status
Orlando Health
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OrlandoUnited StatesUnknown status
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
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PhiladelphiaUnited StatesUnknown status
Providence Oncology and Hematology Care Clinic - Westside
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Adana City Hospital
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AdanaTurkey (Türkiye)Unknown status
Adana Baskent Hospital
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AdanaTurkey (Türkiye)Unknown status
Gazi University Hospital
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AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Trakya University Medical Faculty
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EdirneTurkey (Türkiye)Unknown status
Acıbadem Maslak Hospital
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul University Medical Faculty
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IzmirTurkey (Türkiye)Unknown status
IEU Medical Point Hospital
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IzmirTurkey (Türkiye)Unknown status
Medical Park Samsun Hastanesi
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SamsunTurkey (Türkiye)Unknown status

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