Clinical trial • Oncology|Respiratory

pembrolizumab (biosimilar to pembrolizumab) for Early-stage non-squamous non-small cell lung cancer|Non-squamous non-small cell lung cancer

Clinical trial of pembrolizumab (biosimilar to pembrolizumab) for Early-stage non-squamous non-small cell lung cancer|Non-squamous non-small cell lung can…

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Early-stage non-squamous non-small cell lung cancer|Non-squamous non-small cell lung cancer
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-02-2024
First CTIS Authorization Date
31-05-2024

Trial design

None/Not specified-controlled trial across 61 sites in Poland, Bulgaria, Italy and others.

Comparator
None/Not specified
Target Sample Size
71

Recruitment

Planned Sample Size
71
Recruitment Window Months
33

Geography

Total Number Of Sites
61
Total Number Of Participants
84

Poland

Latest Decision Or Authorization Date
04-12-2025
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.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
j.kolbsielecki@gmail.com
Site Name
Gyncentrum Sp. z o.o.
Department Name
Gyncentrum - Szpital
Contact Person Name
Agnieszka Boratyn-Nowicka
Contact Person Email
m.zemelka@holsaclinical.com
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii I
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawski@co.bydgoszcz.pl
Site Name
Specjalistyczne Gabinety Sp. z o.o.
Contact Person Name
Joanna Streb
Contact Person Email
j.t.banach@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

Bulgaria

Latest Decision Or Authorization Date
26-11-2025
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
UMHAT Sofiamed OOD
Department Name
Department of Medical Oncology
Contact Person Name
Velko Minchev
Contact Person Email
V_minchev@abv.bg

Italy

Latest Decision Or Authorization Date
28-11-2025
Number Of Sites
13
Number Of Participants
13

Sites

Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
U O Oncologia Toracica
Contact Person Name
Antonio Santo
Site Name
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Department Name
Dipartimentico di Oncologia
Contact Person Name
Elena Bolzacchini
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
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
UOC Oncologia
Contact Person Name
Mario Scartozzi
Contact Person Email
marioscartozzi@gmail.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Site Name
Azienda Sanitaria Locale Napoli 1 Centro
Department Name
UOC Oncologia
Contact Person Name
Bruno Daniele
Contact Person Email
b.daniele@libero.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
Careggi University Hospital
Department Name
SODc Clinical Oncology
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
Lorenzo.antonuzzo@unifi.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology division
Contact Person Name
Editta Baldini
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UO Oncologia, Dipartimento Onco-Ematologico
Contact Person Name
Manolo D’Arcangelo
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica
Contact Person Name
Andrea Camerini
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Humanitas Gavazzeni
Contact Person Name
Chiara Matilde Catania
Contact Person Email
Chiara.catania@gavazzeni.it
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Oncology Department
Contact Person Name
Ida Colantonio
Contact Person Email
colantonio.i@ospedale.cuneo.it

Romania

Latest Decision Or Authorization Date
21-01-2026
Number Of Sites
5
Number Of Participants
1

Sites

Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Contact Person Name
Simona Volovat
Contact Person Email
simonavolovat@gmail.com
Site Name
Oncomed S.R.L.
Department Name
Oncology
Contact Person Name
Serban Negru
Contact Person Email
snegru@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
Oncology
Contact Person Name
Adrian Anghel Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncology
Contact Person Name
Roxana Scheusan
Contact Person Email
office@oncocenter.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Contact Person Name
Tudor Eliade Ciuleanu
Contact Person Email
office@iocn.ro

Germany

Latest Decision Or Authorization Date
16-01-2026
Number Of Sites
2
Number Of Participants
12

Sites

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
Justus-Liebig-Universitaet Giessen
Department Name
Hämatologie und Internistische Onkologie
Contact Person Name
Thomas Wehler

Spain

Latest Decision Or Authorization Date
26-12-2025
Number Of Sites
25
Number Of Participants
25

Sites

Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Contact Person Name
María Florencia García Casabal
Contact Person Email
florencia.garcia@iob-onco.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Jesús Corral Jaime
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Francisco de Asis Aparisi Aparisi
Contact Person Email
Francisco_aparisi@iislafe.es
Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
Manuel.cobo.co@quironsalud.es
Site Name
Hospital General Universitario De Elche
Department Name
Oncology
Contact Person Name
Asia Ferrández Arias
Contact Person Email
asiaariasf@gmail.com
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Oncology
Contact Person Name
Inmaculada Maestu Maiques
Contact Person Email
maestu_inm@gva.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
Instituto Multidisciplinar De Oncologia S.A.
Department Name
Oncology
Contact Person Name
Esther Holgado Martín
Contact Person Email
esther.holgado@genesiscare.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Jorge José García González
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Gema María García Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Manuel Domine Gomez
Contact Person Email
mdomine@fjd.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Micancer Center S.L.P.
Department Name
Oncology
Contact Person Name
Santiago Viteri Ramirez
Contact Person Email
sviteri@uomi.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology
Contact Person Name
Soledad Cameselle García
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
María de los Reyes Bernabe Caro
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Joaquin Mosquera Martinez
Site Name
Consorci Sanitari Del Maresme
Department Name
Oncology
Contact Person Name
Laura Punti Brun
Contact Person Email
lpunti@csdm.cat
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Víctor Albarrán Artahona
Contact Person Email
valbaran@panoncology.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Oncology
Contact Person Name
Elisabeth Jiménez Aguilar
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncology
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
Oncology
Contact Person Name
Margarita Amenedo Gancedo
Contact Person Email
margarita.amenedo@cog.es

France

Latest Decision Or Authorization Date
15-12-2025
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie Médicale
Contact Person Name
Charlotte Domblides
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital de jour d’oncologue thoracique
Contact Person Name
Gerard Zalcman
Contact Person Email
gerard.zalcman@aphp.fr
Site Name
Hopital Europeen Marseille
Department Name
Service des Maladies Respiratoires
Contact Person Name
Jacques Le Treut
Contact Person Email
j.letreut@hopital-europeen.fr
Site Name
Centre Francois Baclesse
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Ramsay Generale De Sante
Department Name
Oncology
Contact Person Name
Maciej Rotarski
Contact Person Email
maciej.rotarski@copb.eu
Site Name
Hopitaux Prives De Metz
Department Name
Pulmonology department
Contact Person Name
Lucile Roussel
Contact Person Email
lucile.roussel@uneos.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Service d’Oncologie
Contact Person Name
Clarisse Audigier-Valette
Site Name
Centre Francois Baclesse (duplicate entry in list context)
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Hopitaux Prives De Metz (duplicate/related entry)
Department Name
Pulmonology department
Contact Person Name
Lucile Roussel
Contact Person Email
lucile.roussel@uneos.fr

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 (biosimilar to pembrolizumab)
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous
Investigational Product Name
Keytruda® (pembrolizumab)
Active Substance
pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous

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