Clinical trial • Phase I • Respiratory
pembrolizumab for Non-squamous non-small cell lung cancer (advanced or metastatic)
Phase I trial of pembrolizumab for Non-squamous non-small cell lung cancer (advanced or metastatic).
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Non-squamous non-small cell lung cancer (advanced or metastatic)
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 25-09-2024
Trial design
Keytruda (pembrolizumab); dose and schedule not specified-controlled Phase I trial across 56 sites in France, Bulgaria, Austria and others.
- Comparator
- Keytruda (pembrolizumab); dose and schedule not specified
- Target Sample Size
- 652
Recruitment
- Planned Sample Size
- 652
- Recruitment Window Months
- 49
Geography
- Total Number Of Sites
- 56
- Total Number Of Participants
- 233
France
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 534
- Number Of Sites
- 9
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
- Department Name
- Pneumology
- Contact Person Name
- Clarisse Audigier-Valette
- Contact Person Email
- clarisse.audigier-valette@ch-toulon.fr
- Site Name
- Hopital Europeen Marseille
- Department Name
- Pneumology
- Contact Person Name
- Jacques LeTreut
- Contact Person Email
- j.letreut@hopital-europeen.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Medical Oncology
- Contact Person Name
- Charlotte Domblides
- Contact Person Email
- charlotte.domblides@chu-bordeaux.fr
- Site Name
- Assoc Hospitaliere Nord Artois Clinique
- Department Name
- Pneumology
- Contact Person Name
- Geoffrey Pavaut
- Contact Person Email
- mfery@ahnac.com
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Oncology thoracic Unit
- Contact Person Name
- Elvire Pons-Tostivinit
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Centre De Cancerologue Du Grand Montpellier
- Department Name
- Pneumology
- Contact Person Name
- Catherine Becht
- Contact Person Email
- becht@ccgm.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Oncology
- Contact Person Name
- Sylvie Van Hulst
- Contact Person Email
- sylvie.vanhulst@chu-nimes.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Pneumology
- Contact Person Name
- Thomas Egenod
- Contact Person Email
- thomas.egenod@chu-limoges.fr
- Site Name
- Hopitaux Prives De Metz
- Department Name
- Pneumology
- Contact Person Name
- Julie Perrin
- Contact Person Email
- julie.perrin@uneos.fr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 532
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Bozhil Robev
- Contact Person Email
- bostro@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dobrich AD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Zyuhal Kasimova
- Contact Person Email
- dr.zyuhal.kasimova@gmail.com
- Site Name
- UMHAT Sofiamed OOD
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Velko Minchev
- Contact Person Email
- V_minchev@abv.bg
Austria
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 570
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Pneumology
- Contact Person Name
- Michael Schumacher
- Contact Person Email
- Michael.schumacher@ordensklinikum.at
- Site Name
- Klinik Hietzing
- Department Name
- Klinik Hietzing 5. Med. Abteilung Pavillon 3
- Contact Person Name
- Alexander Kavina
- Contact Person Email
- alexander.kavina@gesundheitsverbund.at
- Site Name
- Landeskrankenanstalten-Betriebsgesellschaft Kabeg
- Department Name
- Department of pulmonary diseases
- Contact Person Name
- Barbara Mittergradnegger
- Contact Person Email
- barbara.mittergradnegger@kabeg.at
Spain
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 532
- Number Of Sites
- 16
- Number Of Participants
- 57
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Contact Person Name
- Emilio Esteban Gonzalez
- Contact Person Email
- eestebang@seom.org
- Site Name
- Micancer Center S.L.P.
- Department Name
- Oncology
- Contact Person Name
- Santiago Viteri Ramirez
- Contact Person Email
- sviteri@uomi.es
- Site Name
- Consorci Sanitari Del Maresme
- Department Name
- Oncology
- Contact Person Name
- Laura Punti Brun
- Contact Person Email
- lpunti@csdm.cat
- Site Name
- Hospital Quironsalud Valencia
- Department Name
- Oncology
- Contact Person Name
- Francisco Aparisi Aparisi
- Contact Person Email
- francisco.aparisi.co@quironsalud.es
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Oncology
- Contact Person Name
- José Fuentes Pradera
- Contact Person Email
- fuentespradera@hotmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Oncology
- Contact Person Name
- Asia Ferrández Arias
- Contact Person Email
- asiaariasf@gmail.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Contact Person Name
- María Florencia García Casabal Cid
- Contact Person Email
- florencia.garcia@iob-onco.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- Manuel.cobo.co@quironsalud.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- María de los Reyes Bernabe Caro
- Contact Person Email
- reyes.bernabe@juntadeandalucia.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Oscar José Juan Vidal
- Contact Person Email
- Juan_osc@gva.es
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Contact Person Name
- Ana Laura Ortega Granados
- Contact Person Email
- oncojaen@fibao.es
- Site Name
- Instituto Multidisciplinar De Oncologia S.A.
- Department Name
- Oncology
- Contact Person Name
- Esther Holgado Martín
- Contact Person Email
- esther.holgado@genesiscare.es
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Oncology
- Contact Person Name
- Rafael López Castro
- Contact Person Email
- rlopezc@saludcastillayleon.es
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Oncology
- Contact Person Name
- Elisabeth Jimenez Aguilar
- Contact Person Email
- elisabeth.jimenez@salud.madrid.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- Carlos Aguado De La Rosa
- Contact Person Email
- carlos.aguadodela@salud.madrid.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Manuel Domine Gomez
- Contact Person Email
- mdomine@fjd.es
Italy
- Earliest CTIS Part Ii Submission Date
- 04-09-2024
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 518
- Number Of Sites
- 11
- Number Of Participants
- 53
Sites
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Oncoematologia
- Contact Person Name
- Carmina Maria Della Corte
- Contact Person Email
- carminiamaria.dellacorte@unicampania.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- UOSD Pneumo- oncologia
- Contact Person Name
- Giuditta Di Isernia
- Contact Person Email
- gdiisernia@scamilloforlanini.rm.it
- Site Name
- Azienda Socio Sanitaria Territoriale Di Cremona
- Department Name
- Oncologia
- Contact Person Name
- Stefano Panni
- Contact Person Email
- Stefano.panni@asst-cremona.it
- Site Name
- Azienda Sanitaria Locale Napoli 1 Centro
- Department Name
- UOC Oncologia
- Contact Person Name
- Bruno Daniele
- Contact Person Email
- bruno.daniele@aslnapoli1centro.it
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
- Department Name
- SC Oncologia Medica
- Contact Person Name
- Ornella Fusco
- Contact Person Email
- ornella.fusco@asst-val.it
- Site Name
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- S.C. Oncologia Medica
- Contact Person Name
- Cristina Zannori
- Contact Person Email
- c.zannori@aospterni.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SC Oncologia Medica
- Contact Person Name
- Claudia Maria Regina Bareggi
- Contact Person Email
- claudia.bareggi@policlinico.mi.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- UO Oncologia
- Contact Person Name
- Luana Calabrò
- Contact Person Email
- Luana.calabro@unife.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- UO Oncologia, Dipartimento Onco-Ematologico
- Contact Person Name
- Manolo D’Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- San Camillo Forlanini Hospital (additional/contact)
- Department Name
- UOSD Pneumo- oncologia
- Site Name
- Other Italian participating hospitals (listed in CTIS)
Poland
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 08-02-2026
- Processing Time Days
- 517
- Number Of Sites
- 7
- Number Of Participants
- 60
Sites
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii I
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddzial onkologii z pododdzialem chemioterapii
- Contact Person Name
- Jaroslaw Kolb-Sielecki
- Contact Person Email
- psocha@pulmonologia.olsztyn.pl
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- not applicable/nie dotyczy
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- badania.kliniczne@medpolonia.com.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej, Chemioterapii
- Contact Person Name
- Wojciech Rogowski
- Contact Person Email
- tymoteusz.czujko@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Kliniczny Oddzial Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorob Wewnetrznych
- Contact Person Name
- Janusz Milanowski
- Contact Person Email
- oddzial.pulmonologii@spsk4.lublin.pl
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
- Contact Person Name
- Tomasz Jankowski
- Contact Person Email
- neuromed.lublin@gmail.com
- Site Name
- Other Polish participating centres (listed in CTIS)
Germany
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 563
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Onkologie UnterEms
- Contact Person Name
- Lothar Müller
- Contact Person Email
- info@onkologie-ue.de
- Site Name
- Klinikum St Marien Amberg
- Contact Person Name
- Ludwig Fischer von Weikersthal
- Contact Person Email
- weikersthal.ludwig@klinikum-amberg.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Hämatologie und Internistische Onkologie
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- Thomas.wehler@innere.med.uni-giessen.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Internistische Onkologie &Onkologische Palliativmedizin
- Contact Person Name
- Sebastian W. Ertl
- Contact Person Email
- onkologie@kem-med.com
- Site Name
- Klinikum Aschaffenburg-Alzenau gGmbH
- Contact Person Name
- Manfred Welslau
- Contact Person Email
- manfred.welslau@klinikum-ab-alz.de
- Site Name
- Dr. Vehling-Kaiser MVZ GmbH
- Contact Person Name
- Ursula Vehling-Kaiser
- Contact Person Email
- studien@vehling-keiser.de
- Site Name
- Friedrich-Ebert-Krankenhaus Neumuenster GmbH
- Department Name
- Klinik Hämatologie, Onkologie und Nephrologie
- Contact Person Name
- Siegfried Haas
- Contact Person Email
- siegfried.haas@fek.de
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- ABP 234
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- Keytruda (pembrolizumab)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised product (reference)
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