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NCT05668988Active, not recruitingPhase 3

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
324 (actual)
First submitted
20 Dec 2022
Start date
13 Dec 2022
Primary completion date
16 Jan 2026
Lead sponsor
Dizal Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT05668988

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 324
  • From 13 Dec 2022 to the primary completion date, 16 Jan 2026
  • 154 sites in 15 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

  • Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  • History of stroke or intracranial hemorrhage within 6 months before randomization.

Other illness

  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Lab values

  • Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.

Other

  • Spinal cord compression or leptomeningeal metastasis.

Who the study is looking for

  • Aged at least 18 years old (or per local regulatory/IRB requirement).
  • Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
  • Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
  • At least 1 measurable lesion per RECIST Version 1.1
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate organ and hematologic function

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

Full criteria on ClinicalTrials.gov

Sites (154)

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

SiteCityCountrySite status
Centro Medico Austral
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Buenos AiresArgentinaUnknown status
Fundacion Cenit Para El Estudio De Neurociencias
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Buenos AiresArgentinaUnknown status
Consultorios Medicos Dr. Doreski - Fundacion Respirar
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Buenos AiresArgentinaUnknown status
Instituto Argentino de Diagnositco y Tratamiento S.A
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Buenos AiresArgentinaUnknown status
Fundacion Estudios Clinicos
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RosarioArgentinaUnknown status
Fundación Ars Médica
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San SalvadorArgentinaUnknown status
Ordensklinikum Linz GmbH Elisabethinen
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LinzAustriaUnknown status
Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ
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SalzburgAustriaUnknown status
Concord Repatriation General Hospital
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ConcordAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Prince of Wales Hospital
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RandwickAustraliaUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumUnknown status
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumUnknown status
UZ Gent
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GhentBelgiumUnknown status
Fundacao PIO XII - Hospital do Cancer de Barretos
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BarretosBrazilUnknown status
Hospital Evangelico de Cachoeiro de Itapemirim
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Cachoeiro de ItapemirimBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino
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RecifeBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino
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Rio de JaneiroBrazilUnknown status
Instituto de Educacao, Pesquisa d Gestao em Saude
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Rio de JaneiroBrazilUnknown status
Instituto Nacional de Câncer - INCA
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Rio de JaneiroBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
London Regional Cancer Program London Health Sciences Centre
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LondonCanadaUnknown status
The Ottawa Hospital Cancer Center
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OttawaCanadaUnknown status
Princess Margaret Cancer Center, University Health Network
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TorontoCanadaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Beijing chest hospital, Capital Medical University
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BeijingChinaUnknown status
Cancer Hospital of the Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chongqing Cancer Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
The First Affiliated 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
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaUnknown status
Jilin Cancer Hospital
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Jilin CityChinaUnknown status
Shandong Cancer Hospital & Institution
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JinanChinaUnknown status
Central Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Jiangsu Cancer Hospital
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NanjingChinaUnknown status
Jiangsu Provincial Hospital
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NanjingChinaUnknown status
Guangxi Medical University Cancer Hospital
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NanningChinaUnknown status
Zhongshan Hospital,Fudan University
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ShanghaiChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
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ShenzhenChinaUnknown status
The Fourth Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
Taizhou Hospital of Zhejiang Province
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TaizhouChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaUnknown status
The Affiliated Cancer Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni nemocnice Olomouc
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OlomoucCzechiaUnknown status
Nemocnice AGEL Ostrava - Vitkovice a.s.
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OstravaCzechiaUnknown status
Evangelische Lungenklinik Berlin
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BerlinGermanyUnknown status
Asklepios Klinik Gauting GmbH
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GautingGermanyUnknown status
MVZ Ⅱ der Niels Stensen Kliniken
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GeorgsmarienhütteGermanyUnknown status
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyUnknown status
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik
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MainzGermanyUnknown status
Universitatsklinik Innere Medizin-Onkologie
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OldenburgGermanyUnknown status
Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainUnknown status
Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Universitari Germans Trias i Pujol
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BarcelonaSpainUnknown status
UOMI Cancer Center - Clinica Mi Tres Torres
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitari Dexeus
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BarcelonaSpainUnknown status
Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta
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GironaSpainUnknown status
Hospital Universitario De Jerez
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Jerez de la FronteraSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital HM Sanchinarro
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MadridSpainUnknown status
Clinica Universidad de Navarra
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MadridSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Regional Universitario de Malaga
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MálagaSpainUnknown status
Hospital Universitario Virgen de Valme
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SevilleSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Centre Hospitalier Universitaire D'Angers
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AngersFranceUnknown status
HCL - Hôpital Louis Pradel
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BronFranceUnknown status
Centre Hospitalier Intercommunal de Creteil (CHIC
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CréteilFranceUnknown status
Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon
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Hellemmes-LilleFranceUnknown status
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
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La TroncheFranceUnknown status
Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord
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MarseilleFranceUnknown status
Centre de Cancérologie du Grand Montpellier
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MontpellierFranceUnknown status
AP-HP Hôpital Cochin
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ParisFranceUnknown status
Hopital Bichat - Claude Bernard - AP-HP
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ParisFranceUnknown status
Hôpital Paris Saint Joseph
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ParisFranceUnknown status
Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon
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ParisFranceUnknown status
Cetre Hospitalier Universitaire de Poitiers
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PoitiersFranceUnknown status
Institut de Cancérologie de l'Ouest
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Saint-HerblainFranceUnknown status
CHU de Nantes - Saint Herblain
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Saint-HerblainFranceUnknown status
Hopital d'Instruction des Armees (HIA) Begin
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Saint-MandéFranceUnknown status
Hopital Foch
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SuresnesFranceUnknown status
Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS
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AvianoItalyUnknown status
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola
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BolognaItalyUnknown status
Aou Policlinico G. Rodolico - S. Marcoa
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CataniaItalyUnknown status
Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI
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FlorenceItalyUnknown status
Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto
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GrossetoItalyUnknown status
Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)
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MeldolaItalyUnknown status
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyUnknown status
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyUnknown status
Casa di Cura di Alta Specialita - Palermo
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PalermoItalyUnknown status
Azienda Ospedaliero Universitaria di Parma
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ParmaItalyUnknown status
Ausl Della Romagna-Po Ravenna Lugo Faenza
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RavennaItalyUnknown status
AUSL IRCCS di Reggio Emilia
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Reggio EmiliaItalyUnknown status
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
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RomaItalyUnknown status
Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle
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SienaItalyUnknown status
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK)
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GdanskPolandUnknown status
Med Polonia Sp z o.o.
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PoznanPolandUnknown status
Wojewódzki Szpital im. św. Ojca Pio
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PrzemyślPolandUnknown status
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
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WarsawPolandUnknown status
University of Colorado Hospital Anschutz Cancer Pavilion
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AuroraUnited StatesUnknown status
Gabrail Cancer Center Research
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CantonUnited StatesUnknown status
University of Virginia Comprehensive Cancer Center
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CharlottesvilleUnited StatesUnknown status
OSU Brain & Spine Hospital
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ColumbusUnited StatesUnknown status
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesUnknown status
OPN Healthcare, Inc
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GlendaleUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
D&H Cancer Research Center LLC
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MargateUnited StatesUnknown status
NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
BRCR Medical Center Inc
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PlantationUnited StatesUnknown status
Providence Portland Institute Franz
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PortlandUnited StatesUnknown status
Kaiser Permanente Medical Center
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VallejoUnited StatesUnknown status
exas Oncology--McAllen
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WeslacoUnited StatesUnknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Liv Hospital Ankara - Medical Oncology Clinic
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AnkaraTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Gazi University Faculty of Medicine Hospital
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AnkaraTurkey (Türkiye)Unknown status
Trakya University Health Research and Application Center Hospital
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EdirneTurkey (Türkiye)Unknown status
Bezmialem Vakif University
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IstanbulTurkey (Türkiye)Unknown status
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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KadıköyTurkey (Türkiye)Unknown status
Necmettin Erbakan University Meram Faculty of Medicine
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KonyaTurkey (Türkiye)Unknown status

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