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
- Contact Person Email
- Ekkehard.eigendorff@zentralklinik.de
- 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
- Contact Person Email
- Cornelius.waller@uniklinik-freiburg.de
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
- Contact Person Email
- andrei.ungureanu@amethyst-radiotherapy.com
- 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
- Contact Person Email
- sricciardi@scamilloforlanini.rm.it
- 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
- Contact Person Email
- alexandra.szabova@pentahospitals.sk
- 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
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- 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
- Contact Person Email
- joaquin.mosquera.martinez@sergas.es
- 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
- Contact Person Email
- ensayoscancerpulmonfjd@gmail.com
- 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
- Contact Person Email
- jorge.jose.garcia.gonzalez@sergas.es
- 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
- Contact Person Email
- uicico_badalona@iconcologia.net
- 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
- Contact Person Email
- Maria.Felizardo@hospitaldaluz.pt
- 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
- Contact Person Email
- andrea.machado@ulssm.min-saude.pt
- 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
- Contact Person Email
- venceslau.hespanhol@jmellosaude.pt
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
- Contact Person Email
- wojciech.rogowski.apple@gmail.com
- 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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