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NCT06161441Active, not recruitingPhase 2

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
195 (actual)
First submitted
29 Nov 2023
Start date
16 Jul 2024
Primary completion date
24 Aug 2026
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT06161441
EU CT number
2023-505172-29-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 195
  • From 16 Jul 2024 to the primary completion date, 24 Aug 2026
  • 130 sites in 13 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

  • Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.

Other illness

  • Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
  • Patients with a history of myocarditis
    • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Lab values

  • Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol

Who the study is looking for

  • Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
  • For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
  • All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
  • A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, hepatic and kidney function as defined in the protocol

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

Full criteria on ClinicalTrials.gov

Sites (130)

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

SiteCityCountrySite status
Eastern Health
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Box HillAustraliaUnknown status
St. Vincent's Hospital
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FitzroyAustraliaUnknown status
St John of God Murdoch Hospital
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MurdochAustraliaUnknown status
Centro de Oncologia de Precision
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Las CondesChileUnknown status
Orlandi Oncologia
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ProvidenciaChileUnknown status
Clinica Santa Maria
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SantiagoChileUnknown status
Oncocentro Apys
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Viña del MarChileUnknown status
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyActive, not recruiting
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyActive, not recruiting
Justus-Liebig-Universitaet Giessen
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GiessenGermanyActive, not recruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyActive, not recruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyActive, not recruiting
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
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HemerGermanyActive, not recruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyActive, not recruiting
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
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NeussGermanyActive, not recruiting
Hospital Universitari Dexeus Grupo Quironsalud
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BarcelonaSpainActive, not recruiting
Hospital Quirónsalud Barcelona
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BarcelonaSpainActive, not recruiting
Hospital General Universitario de Elche
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ElcheSpainActive, not recruiting
Institut Català d'Oncologia
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GironaSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
Hospital Universitario Lucus Augusti
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LugoSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
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ManresaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainActive, not recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Alvaro Cunqueiro
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VigoSpainActive, not recruiting
Institut de Cancerologie de L'Ouest
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AngersFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Boulogne-BillancourtFranceActive, not recruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceActive, not recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceActive, not recruiting
Medipole De Nancy
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NancyFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Hopitaux Prives De Metz
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VantouxFranceActive, not recruiting
Cancer Center of Adjara
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BatumiGeorgiaUnknown status
TIM - Tbilisi Institute of Medicine
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TbilisiGeorgiaUnknown status
LTD "New Hospitals"
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TbilisiGeorgiaUnknown status
JSC K. Eristavi National Center of Experimental and Clinical Surgery
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TbilisiGeorgiaUnknown status
Institute of Clinical Oncology
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TbilisiGeorgiaUnknown status
High Technology Medical Center, University Clinic Tbilisi
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TbilisiGeorgiaUnknown status
Multiprofile Clinic Consilium Medulla
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TbilisiGeorgiaUnknown status
Llc Todua Clinic
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TbilisiGeorgiaUnknown status
Israeli Georgian Medical Research Clinic Helsicore
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TbilisiGeorgiaUnknown status
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
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AlexandriaItalyActive, not recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyActive, not recruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
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CandioloItalyActive, not recruiting
Azienda Socio-Sanitaria Territoriale di Cremona
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CremonaItalyActive, not recruiting
University Hospital Of Ferrara
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FerraraItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LeghornItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Azienda Sanitaria Territoriale di Pesaro e Urbino
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PesaroItalyActive, not recruiting
Azienda Unita Sanitaria Locale Di Piacenza
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PiacenzaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Inha University Hospital
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IncheonSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
The Catholic University of Korea St Vincents Hospital
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SuwonSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
University of Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Umum Sarawak
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KuchingMalaysiaUnknown status
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
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BucharestRomaniaCompleted
Memorial Healthcare International S R L
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BucharestRomaniaCompleted
CardioMed S.R.L.
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Cluj-NapocaRomaniaCompleted
Medisprof S.R.L.
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Cluj-NapocaRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaCompleted
Oncomed S.R.L.
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TimisoaraRomaniaCompleted
Oncocenter Oncologie Clinica S.R.L
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TimișoaraRomaniaCompleted
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Hualien Tzu Chi Hospital
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Hualien CityTaiwanUnknown 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
Chung Shan Medical University
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TaichungTaiwanUnknown status
Taipei Municipal Wan Fang Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Clermont Oncology Center
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ClermontUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Virginia Cancer Care Specialist, PC
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FairfaxUnited StatesUnknown status
Kaiser Permanente Northwest
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PortlandUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Mercy South
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St LouisUnited StatesUnknown status
University of Kansas Cancer Center-Westwood
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WestwoodUnited StatesUnknown status
Acibadem Adana Hastanesi
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AdanaTurkey (Türkiye)Unknown status
Adana City Education and Research Hospital
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AdanaTurkey (Türkiye)Unknown status
Baskent University Adana Turgut Noyan Hospital
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AdanaTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hospital
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe University Cancer Institute
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AnkaraTurkey (Türkiye)Unknown status
Ankara University Faculty of Medicine
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AnkaraTurkey (Türkiye)Unknown status
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Unknown status
Gulhane Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ege University Faculty of Medicine
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BornovaTurkey (Türkiye)Unknown status
Medical Point Gaziantep Hastanesi
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GaziantepTurkey (Türkiye)Unknown status
Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
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IstanbulTurkey (Türkiye)Unknown status
Bezmialem Vakif University
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Koc University
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IstanbulTurkey (Türkiye)Unknown status
Kocaeli University Hospital
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KocaeliTurkey (Türkiye)Unknown status
Necmettin Erbakan University Meram Faculty of Medicine
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KonyaTurkey (Türkiye)Unknown status
Ondokuz Mayıs University
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KurupelitTurkey (Türkiye)Unknown status
Faculty of Medicine of Sakarya University
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SakaryaTurkey (Türkiye)Unknown status

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