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

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Investigational drug late phase More information Active drug More information Low burden on patient More information

Trial Details

Sponsor: Dizal Pharmaceuticals (industry)

Phase: 3

Start date: Dec. 13, 2022

Planned enrollment: 320

Last updated in HealthScout: Dec 2024

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chevron Show for: DZD9008 (sunvozertinib)

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Trial ID: NCT05668988
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More trial details at ClinicalTrials.gov More info

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Goal: The aim of this clinical trial is to evaluate the efficacy and safety of DZD9008, an investigational oral EGFR tyrosine kinase inhibitor, compared to standard platinum-based doublet chemotherapy as first-line treatment in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion mutation.

Patients: The trial is focused on adult patients with a histologically confirmed diagnosis of non-squamous NSCLC that is either locally advanced or metastatic. These patients must have an EGFR exon 20 insertion mutation confirmed through central laboratory testing, be treatment-naïve for advanced stages, and demonstrate a measurable lesion according to RECIST 1.1. Additionally, participants must have a life expectancy of twelve weeks or more and an ECOG performance status of 0 to 1.

Design: This is a Phase 3, open-label, randomized, multi-center study involving approximately 320 participants. Patients are randomized in a 1:1 ratio to receive either DZD9008 or platinum-based doublet chemotherapy, with stratification based on the presence or absence of baseline brain metastasis.

Treatments: The experimental arm of the trial consists of the investigational drug DZD9008, also known as Sunvozertinib, which is a selective, irreversible EGFR tyrosine kinase inhibitor that specifically targets the exon 20 insertion mutations in EGFR. Previous trials have shown an objective response rate of 53.3% and demonstrated efficacy across various subgroups. The comparator arm involves Pemexetred and carboplatin, which are standard chemotherapy agents used in NSCLC.

Outcomes: The primary outcome measured in this study is Progression-Free Survival (PFS) assessed by a Blinded Independent Central Review, following RECIST 1.1 criteria. The secondary outcome is Overall Survival. Both outcomes will be assessed approximately 34 months post-randomization of the first participant.

Burden on patient: Overall, the study imposes a low to moderate burden on participants. While there are requirements for sufficient tumor tissue for mutation confirmation and regular follow-up assessments for progression and survival metrics, DZD9008 being an oral agent reduces the need for frequent hospital visits typically associated with intravenous chemotherapy. The trial's follow-up involves regular scans, which align with standard care practices, further minimizing additional burden.

Eligibility Criteria More information

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Centro Diabaid

Buenos Aires, Argentina

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Instituto Alexander Fleming

Buenos Aires, Argentina

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Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

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Fundacion Cenit Para El Estudio De Neurociencias

Buenos Aires, Argentina

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Status: Completed

Consultorios Medicos Dr. Doreski - Fundacion Respirar

Buenos Aires, Argentina

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Status: Completed

Centro de Educación Médica e Investigaciones Clínicas, CEMIC

Buenos Aires, Argentina

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Centro Medico Austral

Buenos Aires, Argentina

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Status: Completed

Centro de Investigación Clínicas. Clinica Viedma S.A

Viedma, Argentina

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Fundación Ars Médica

San Salvador, Argentina

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Status: Completed

Fundación Estudios Clínicos

Rosario, Argentina

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Instituto Argentino de Diagnositco y Tratamiento S.A

Buenos Aires, Argentina

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Prince of Wales Hospital

Randwick, Australia

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Sir Charles Gairdner Hospital, Heart Research Insititute

Nedlands, Australia

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Peter MacCallum Cancer Centre

Melbourne, Australia

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Concord Cancer Centre Medical Oncology Clinical Trials Unit Concord Repatriation General Hospital

Concord, Australia

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Uniklinikum Salzburg

Salzburg, Austria

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Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

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Antwerpen University Hospital (UZA)

Edegem, Antwerp, Belgium

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University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)

Ghent, Flanders, Belgium

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Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame

Charleroi, Hainaut, Belgium

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Fundacao PIO XII - Hospital do Cancer de Barretos

Barretos, Brazil

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Liga Norte Riograndense Contra o Câncer

Natal, Brazil

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Hospital São Lucas da PUCRS

Porto Alegre, Brazil

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Santa Casa de Misericordia- Porto Alegre - Hospital Santa Rita

Porto Alegre, Brazil

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Instituto D'Or de Pesquisa e Ensino - Recife

Recife, Brazil

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Instituto America(COI)

Rio De Janeiro, Brazil

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Instituto D'Or de Pesquisa e Ensino

Rio De Janeiro, Brazil

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Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio De Janeiro, Brazil

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Instituto do Cancer do Estado de Sao Paulo - ICES

São Paulo, Brazil

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Centro de Pesquisas Clinicas em

Cachoeiro De Itapemirim, Brazil

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The Ottawa Hospital Cancer Center

Ottawa, Canada

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Princess Margaret Cancer Center

Toronto, Canada

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Regional Cancer Program London Health Sciences Centre

London, Canada

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

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Beijing Cancer Hospital

Beijing, China

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Beijing Chest Hospital, Capital Medical University

Beijing, China

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Cancer Hospital of the Chinese Academy of Medical Sciences

Beijing, China

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Peking Union Medical College Hospital

Beijing, China

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Peking University Third Hospital

Beijing, China

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Hunan Cancer Hospital

Changsha, China

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West China Hospital of Sichuan University

Chengdu, China

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Army Medical Center of PLA

Chongqing, China

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Chongqing Cancer Hospital

Chongqing, China

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Fujian Cancer Hospital

Fuzhou, China

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Fujian Medical University Union Hospital

Fuzhou, China

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

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The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

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Zhejiang Cancer Hospital

Hangzhou, China

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Harbin Medical University Cancer Hospital

Harbin, China

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Anhui Provincial Hospital

Hefei, China

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The First Affiliated Hospital of Anhui Medical University

Hefei, China

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The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

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Status: Completed

Jilin Cancer Hospital

Jilin, China

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Central Hospital Affiliated to Shandong First Medical University

Jinan, China

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Shandong Cancer Hospital & Institution

Jinan, China

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Yunnan Cancer Hospital

Kunming, China

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The Second Affiliated Hospital of Nanchang University

Nanchang, China

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Jiangsu Cancer Hospital

Nanjing, China

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Jiangsu Provincial Hospital

Nanjing, China

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Guangxi Medical University Cancer Hospital

Nanning, China

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Shanghai Chest Hospital

Shanghai, China

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Shanghai Pulmonary Hospital

Shanghai, China

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ZhongShan Hospital Fudan University

Shanghai, China

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The First Hospital of China Medical University

Shenyang, China

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Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center

Shenzhen, China

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Status: Completed

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

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Shanxi Provincial Cancer Hospital

Taiyuan, China

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Taizhou Hospital of Zhejiang Province

Taizhou, China

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Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, China

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

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The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, China

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Yantai Yuhuangding Hospital

Yantai, China

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Henan Cancer Hospital

Zhengzhou, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

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Vitkovicka Nemocnice a.s. - Plicni oddeleni

Ostrava, Czechia

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Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

Olomouc, Czechia

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Hopital d'Instruction Des Armees Begin

Saint-Mande, France

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Institut de Cancerologie de L'Ouest

Saint Herblain, France

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Centre Hospitalier Universitaire de Nantes (CHU de Nantes)

Saint Herblain, France

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CHU Poitiers

Poitiers, France

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Hôpital Bichat - Claude Bernard

Paris, France

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Hopital Saint Joseph

Paris, France

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Cochin Hospital

Paris, France

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APHP Hôpital Tenon

Paris, France

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Centre de Cancérologie Montpellier

Montpellier, France

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APHM-Hôpital NORD

Marseille, France

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Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

La Tronche, France

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Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Albert Calmette - Clinique des Maladies Respiratoires

Hellemmes-Lille, France

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Centre Hospitalier Intercommunal de Creteil (CHIC)

Créteil, France

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Hôpital Louis Pradel

Bron, France

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Centre Hospitalier Universitaire d'Angers

Angers, France

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Hopital Foch

Suresnes, France

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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik

Mainz, Germany

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Evangelische Lungenklinik Berlin - Klinik fuer Pneumologie

Berlin, Germany

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Asklepios Klinik Gauting GmbH - Klinik fuer Thorakale Onkologie

Gauting, Germany

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Niels-Stensen-Kliniken - Franziskus-Hospital Harderberg

Georgsmarienhütte, Germany

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Status: Recruiting

Universitaetsklinikum Heidelberg (UKHD) - Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany

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Pius-Hospital Oldenburg - Klinik fuer Haematologie und Onkologie

Oldenburg, Germany

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Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)

Reggio Emilia, Italy

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Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori (ITT) - Center for Immuno-Oncology (CIO)

Siena, Italy

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IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena

Roma, Italy

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Servizio Sanitario Regionale Emilia-Romagna - Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)

Meldola, Italy

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Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena

Modena, Italy

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Azienda Ospedaliera San Gerardo - Monza

Monza, Italy

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La Maddalena Casa di Cura di Alta Specialita - Palermo

Palermo, Italy

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Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

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Azienda Unità Sanitaria Locale Romagna

Ravenna, Italy

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Università degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI

Florence, Italy

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Centro di Riferimento Oncologico (CRO Aviano)

Aviano, Italy

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Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Italy

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Azienda Ospedaliero - Universitaria "Policlinico-Vittorio Emanuele" Catania

Catania, Italy

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Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto

Grosseto, Italy

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Status: Recruiting

Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)

Maastricht, Netherlands

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Status: Not yet recruiting

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdańsk, Poland

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Status: Recruiting

Wojewódzki Szpital im. św. Ojca Pio

Przemyśl, Poland

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Status: Recruiting

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy

Warsaw, Poland

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Status: Recruiting

MED-POLONIA Sp. z o.o.

Poznań, Poland

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Status: Recruiting

Hospital Universitario Fundación Jiménez Diaz

Madrid, Spain

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Status: Recruiting

Hospital Regional Universitario de Málaga

Málaga, Spain

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Hospital Universitario Virgen de Valme

Sevilla, Spain

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Hospital Universitario Virgen del Rocio

Sevilla, Spain

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Hospital Universitario Virgen Macarena

Sevilla, Spain

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Hospital Clinico Universitario de Valencia

Valencia, Spain

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Hospital Universitari i Politècnic La Fe

Valencia, Spain

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Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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Hospital Universitari Vall d'Hebron

Barcelona, Spain

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Institut Catala d'Oncologia Badalona (ICO Badalona) - Hospital Germans Trias i Pujol

Barcelona, Spain

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Instituto Oncológico Dr Rosell Hospital Quiron Dexeus

Barcelona, Spain

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UOMI Cancer Center - Clinica Tres Torres

Barcelona, Spain

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Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta

Girona, Spain

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Status: Recruiting

Hospital Universitario de Jerez

Jerez De La Frontera, Spain

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Status: Recruiting

Clínica Universidad de Navarra - Madrid

Madrid, Spain

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Hospital HM Sanchinarro

Madrid, Spain

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Hospital Universitario 12 de Octubre

Madrid, Spain

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Hospital Universitario La Paz

Madrid, Spain

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Ankara Bilkent City Hospital Universiteler Mahallesi

Ankara, Turkey

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Status: Recruiting

Dr. Abdurrahman Yurtaslan Ankara Oncology Training

Ankara, Turkey

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Status: Recruiting

Necmettin Erbakan University

Konya, Turkey

No email / No phone

Status: Recruiting

Prof. Dr. Süleyman Yalçın Şehir Hastanesi - Tibbi Onkoloji Klinigi

Kadıköy, Turkey

No email / No phone

Status: Recruiting

Bezmialem University Hospital

Istanbul, Turkey

No email / No phone

Status: Recruiting

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane

Edirne, Turkey

No email / No phone

Status: Recruiting

Liv Hospital Ankara - Medical Oncology Clinic

Ankara, Turkey

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Status: Recruiting

Gazi Universitesi Tip Fakultesi (Gazi University Faculty of Medicine) - Gazi Hastanesi (Gazi Hospital)

Ankara, Turkey

No email / No phone

Status: Recruiting

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

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Status: Recruiting

OPN Healthcare, Inc.

Glendale, California, 91203, United States

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Status: Recruiting

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

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Status: Recruiting

D&H Cancer Research Center

Margate, Florida, 33054, United States

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Status: Recruiting

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

No email / No phone

Status: Not yet recruiting

Brcr Global

Plantation, Florida, 33324, United States

No email / No phone

Status: Recruiting

Columbia University Medical Center

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

NYU Laura & Issac Perlmutter Cancer Center

New York, New York, 10016, United States

No email / No phone

Status: Recruiting

The Ohio State University

Columbus, Ohio, 43210, United States

No email / No phone

Status: Recruiting

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

No email / No phone

Status: Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213, United States

No email / No phone

Status: Completed

MD Anderson cancer center

Houston, Texas, 77030, United States

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Status: Recruiting

USOR - Texas Oncology--Weslaco

Weslaco, Texas, 78596, United States

No email / No phone

Status: Recruiting

USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

No email / No phone

Status: Recruiting

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22908, United States

No email / No phone

Status: Recruiting

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