Clinical trial • Phase III • Oncology

pembrolizumab for Advanced/metastatic non-squamous non-small cell lung cancer

Phase III trial of pembrolizumab for Advanced/metastatic non-squamous non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced/metastatic non-squamous non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
20-11-2024
First CTIS Authorization Date
25-03-2025

Trial design

Keytruda (pembrolizumab); dose and schedule not specified-controlled Phase III trial in Croatia, Germany, Romania and others.

Comparator
Keytruda (pembrolizumab); dose and schedule not specified
Target Sample Size
392

Eligibility

Recruits 392 No vulnerable population selected (isVulnerablePopulationSelected=false). No details on consent or assent provided..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). No details on consent or assent provided.

Recruitment

Planned Sample Size
392
Recruitment Window Months
26

Geography

Total Number Of Sites
58
Total Number Of Participants
111

Croatia

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
13
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Pula General Hospital Ospedale Generale di Pola
Department Name
Department of Internal Oncology and Hematology
Principal Investigator Name
Dragan Trivanovic
Principal Investigator Email
dragan.trivanovic@obpula.hr
Contact Person Name
Dragan Trivanovic
Contact Person Email
dragan.trivanovic@obpula.hr
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Clinic for Tumors Zagreb, Department of Medical Oncology
Principal Investigator Name
Ljubica Vazdar
Principal Investigator Email
ljubica.vazdar@kbcsm.hr
Contact Person Name
Ljubica Vazdar
Contact Person Email
ljubica.vazdar@kbcsm.hr

Germany

Earliest CTIS Part Ii Submission Date
20-03-2025
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
5
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für internistische Hämatologie, Onkologie und Privatmedizin
Principal Investigator Name
Ekkehard Eigendorff
Principal Investigator Email
Ekkehard.eigendorff@zentralklinik.de
Contact Person Name
Ekkehard Eigendorff
Site Name
ohO Research GmbH
Department Name
Hämatologie/Onkologie der Sana Klinik Ostholstein
Principal Investigator Name
Gerdt Hübner
Principal Investigator Email
gerdt.huebner@sigal-sms.de
Contact Person Name
Gerdt Hübner
Contact Person Email
gerdt.huebner@sigal-sms.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin, Interdisziplinäres Tumorzentrum
Principal Investigator Name
Cornelius Waller
Principal Investigator Email
Cornelius.waller@uniklinik-freiburg.de
Contact Person Name
Cornelius Waller

Romania

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
516
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Sectia Oncologie Medicala
Principal Investigator Name
Tudor-Eliade Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Roxana Ioana Scheusan
Principal Investigator Email
office@oncocenter.ro
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
office@oncocenter.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
andrei.ungureanu@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Oncolab S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Dan Stelian Stefan Lungulescu
Principal Investigator Email
dan.lungulescu@yahoo.com
Contact Person Name
Dan Stelian Stefan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Onco Card S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Bogdan Daniel Carlan
Principal Investigator Email
bogdancarlan@gmail.com
Contact Person Name
Bogdan Daniel Carlan
Contact Person Email
bogdancarlan@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
511
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
SC Oncology
Principal Investigator Name
Stefano Panni
Principal Investigator Email
stefano.panni@asst-cremona.it
Contact Person Name
Stefano Panni
Contact Person Email
stefano.panni@asst-cremona.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncologia 1
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 2
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
UOC Immunoterapia Oncologica
Principal Investigator Name
Michele Maio
Principal Investigator Email
maio@unisi.it
Contact Person Name
Michele Maio
Contact Person Email
maio@unisi.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Unitá di Oncologia Toracica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Gianpiero Romano
Principal Investigator Email
giampieroromano@tiscali.it
Contact Person Name
Gianpiero Romano
Contact Person Email
giampieroromano@tiscali.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncologia Medica
Principal Investigator Name
Salvatore Grisanti
Principal Investigator Email
grisanti.salvatore@gmail.com
Contact Person Name
Salvatore Grisanti
Contact Person Email
grisanti.salvatore@gmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
UOSD Pneumo-oncologia
Principal Investigator Name
Serena Ricciardi
Principal Investigator Email
sricciardi@scamilloforlanini.rm.it
Contact Person Name
Serena Ricciardi
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU Oncologia Medica
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Sociosanitaria 3
Department Name
SSD Oncologia
Principal Investigator Name
Paola Taveggia
Principal Investigator Email
paola.taveggia@asl3.liguria.it
Contact Person Name
Paola Taveggia
Contact Person Email
paola.taveggia@asl3.liguria.it

Slovakia

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
426
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Nsp Sv. Jakuba N.O. Bardejov
Department Name
Not applicable
Principal Investigator Name
Jozef Chovanec
Principal Investigator Email
jozefchovanec@nsp-bardejov.sk
Contact Person Name
Jozef Chovanec
Contact Person Email
jozefchovanec@nsp-bardejov.sk
Site Name
Nemocnica Na Okraji Mesta N.O.
Department Name
Not applicable
Principal Investigator Name
Alexandra Szabová
Principal Investigator Email
alexandra.szabova@pentahospitals.sk
Contact Person Name
Alexandra Szabová
Site Name
University Hospital Bratislava
Department Name
Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Oddelenie klinickej onkológie
Principal Investigator Name
Zuzana Šviheľová Lišková
Principal Investigator Email
zuzana.svihelova@ru.unb.sk
Contact Person Name
Zuzana Šviheľová Lišková
Contact Person Email
zuzana.svihelova@ru.unb.sk

Spain

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
426
Number Of Sites
16
Number Of Participants
30

Sites

Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuel.cobo.co@quironsalud.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Principal Investigator Name
Fernando Fabio Franco Pérez
Principal Investigator Email
ffranco@fundacionmdanderson.es
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Principal Investigator Name
Jose Fuentes Pradera
Principal Investigator Email
fuentespradera@hotmail.com
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Joaquin Mosquera Martinez
Principal Investigator Email
joaquin.mosquera.martinez@sergas.es
Contact Person Name
Joaquin Mosquera Martinez
Site Name
Consorci Sanitari Integral
Department Name
Oncology
Principal Investigator Name
Jesús Brenes Castro
Principal Investigator Email
jbrenesc@csi.cat
Contact Person Name
Jesús Brenes Castro
Contact Person Email
jbrenesc@csi.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Dómine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Dómine Gomez
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Principal Investigator Name
Fabricio Racca Bussano
Principal Investigator Email
fracca@nextoncology.eu
Contact Person Name
Fabricio Racca Bussano
Contact Person Email
fracca@nextoncology.eu
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Jorge Garcia Gonzalez
Principal Investigator Email
jorge.jose.garcia.gonzalez@sergas.es
Contact Person Name
Jorge Garcia Gonzalez
Site Name
Hospital Moncloa Grupo Hla S.A.
Department Name
Oncology
Principal Investigator Name
Daniel Herrero Rivera
Principal Investigator Email
daniel.herrero@bienzobas.es
Contact Person Name
Daniel Herrero Rivera
Contact Person Email
daniel.herrero@bienzobas.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Emilio Esteban Gonzales
Principal Investigator Email
eestebang@seom.org
Contact Person Name
Emilio Esteban Gonzales
Contact Person Email
eestebang@seom.org
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Vicente Ruiz Cordero
Principal Investigator Email
vruiz@fivo.org
Contact Person Name
Vicente Ruiz Cordero
Contact Person Email
vruiz@fivo.org
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Marc Cucurull Salamero
Principal Investigator Email
uicico_badalona@iconcologia.net
Contact Person Name
Marc Cucurull Salamero
Site Name
University Hospital Son Espases
Department Name
Oncology
Principal Investigator Name
Aitor Azkárate Martínez
Principal Investigator Email
aitor.azkarate@ssib.es
Contact Person Name
Aitor Azkárate Martínez
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Hospital Povisa S.A.
Department Name
Oncology
Principal Investigator Name
Anabel Del Barrio Díaz
Principal Investigator Email
adelbarrio@povisa.es
Contact Person Name
Anabel Del Barrio Díaz
Contact Person Email
adelbarrio@povisa.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Principal Investigator Name
Silverio Ros Martinez
Principal Investigator Email
silveriorosmartinez@gmail.com
Contact Person Name
Silverio Ros Martinez
Contact Person Email
silveriorosmartinez@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
470
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Elena Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Elena Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Medical Oncology Department
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Ioannou Private Clinic-Private Polyclinics S.A.
Department Name
Oncology & Chemotherapy Department
Principal Investigator Name
Evangelos Voulgaris
Principal Investigator Email
evoulg@gmail.com
Contact Person Name
Evangelos Voulgaris
Contact Person Email
evoulg@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Clinic & Research Unit - Oncology Unit
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
Psyrri237@yahoo.com
Contact Person Name
Amanda Psyrri
Contact Person Email
Psyrri237@yahoo.com
Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Medical Oncology Department
Principal Investigator Name
George Gkoumas
Principal Investigator Email
g.goumas@yahoo.com
Contact Person Name
George Gkoumas
Contact Person Email
g.goumas@yahoo.com
Site Name
Theageneio Cancer Hospital
Department Name
Pulmonary-Oncology Department
Principal Investigator Name
Theodora Tsiouda
Principal Investigator Email
doratsiouda@yahoo.gr
Contact Person Name
Theodora Tsiouda
Contact Person Email
doratsiouda@yahoo.gr
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic of Aristotle University of Thessaloniki
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Molecular Medicine Clinic (4th Floor)
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology - Department of Medicine
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr

Portugal

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
419
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Principal Investigator Name
Margarida Felizardo
Principal Investigator Email
Maria.Felizardo@hospitaldaluz.pt
Contact Person Name
Margarida Felizardo
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Oncology
Principal Investigator Name
Marta Vilaça
Principal Investigator Email
marta.vilaca@ulsm.min-saude.pt
Contact Person Name
Marta Vilaça
Contact Person Email
marta.vilaca@ulsm.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Oncology
Principal Investigator Name
Andrea Lopes Machado
Principal Investigator Email
andrea.machado@ulssm.min-saude.pt
Contact Person Name
Andrea Lopes Machado
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology
Principal Investigator Name
Venceslau Hespanhol
Principal Investigator Email
venceslau.hespanhol@jmellosaude.pt
Contact Person Name
Venceslau Hespanhol

Poland

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
420
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej, Chemioterapii, Badan Klinicznych
Principal Investigator Name
Wojciech Rogowski
Principal Investigator Email
wojciech.rogowski.apple@gmail.com
Contact Person Name
Wojciech Rogowski
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Department Name
Nie dotyczy
Principal Investigator Name
Tomasz Jankowski
Principal Investigator Email
tjankowski.onkolog@wp.pl
Contact Person Name
Tomasz Jankowski
Contact Person Email
tjankowski.onkolog@wp.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Agata Kachel-Flis
Principal Investigator Email
agata.kachel-flis@pratia.com
Contact Person Name
Agata Kachel-Flis
Contact Person Email
agata.kachel-flis@pratia.com
Site Name
Instytut Msf Sp. z o.o.
Department Name
Nie dotyczy
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
imsf.clinicaltrials@gmail.com
Contact Person Name
Ewa Kalinka
Contact Person Email
imsf.clinicaltrials@gmail.com
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Principal Investigator Name
Anna Łowczak
Principal Investigator Email
onkoania@gazeta.pl
Contact Person Name
Anna Łowczak
Contact Person Email
onkoania@gazeta.pl

Sponsor

Primary sponsor

Full Name
Mabxience Research S.L.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
MB12 (proposed pembrolizumab biosimilar)
Active Substance
pembrolizumab
Modality
Monoclonal antibody
Investigational Product Name
Keytruda
Active Substance
pembrolizumab
Modality
Monoclonal antibody

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