Clinical trial • Phase III • Oncology
NIVOLUMAB, RELATLIMAB for Non-small cell lung cancer (non-squamous) — Stage IV or recurrent
Phase III trial of NIVOLUMAB, RELATLIMAB for Non-small cell lung cancer (non-squamous) — Stage IV or recurrent.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (non-squamous) — Stage IV or recurrent
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 14-02-2025
- First CTIS Authorization Date
- 11-06-2025
Trial design
Randomised, open-label, pembrolizumab with chemotherapy (comparator arm). chemotherapy agents listed in study documents include pemetrexed disodium plus cisplatin or carboplatin (site/investigator choice); specific doses and schedules are not specified in the provided record.-controlled Phase III trial in Germany, Romania, Ireland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Pembrolizumab with chemotherapy (comparator arm). Chemotherapy agents listed in study documents include pemetrexed disodium plus cisplatin or carboplatin (site/investigator choice); specific doses and schedules are not specified in the provided record.
- Target Sample Size
- 712
Eligibility
Recruits 712 No vulnerable populations selected. Participants must be aged 18 years or older and provide informed consent. Subject information and informed consent forms (L1_SIS and ICF) are provided (multiple country/language versions are included in the documentation)..
- Pregnancy Exclusion
- Women who are pregnant or breastfeeding.
- Vulnerable Population
- No vulnerable populations selected. Participants must be aged 18 years or older and provide informed consent. Subject information and informed consent forms (L1_SIS and ICF) are provided (multiple country/language versions are included in the documentation).
Inclusion criteria
- {"criterion_text":"- The people who can participate in this study are men and women who are 18 years or older."}
- {"criterion_text":"- They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back."}
- {"criterion_text":"- This type of cancer has not been treated with any other cancer drugs before."}
- {"criterion_text":"- The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts."}
- {"criterion_text":"- The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment."}
- {"criterion_text":"- The participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities."}
- {"criterion_text":"- They should also be expected to live for at least 3 months from the start of the study."}
Exclusion criteria
- {"criterion_text":"- Women who are pregnant or breastfeeding."}
- {"criterion_text":"- People who have certain changes in their cancer cells that can be treated with other drugs are also not allowed. Tests are required to determine changes in the EGFR, ALK, ROS-1, and BRAF genes."}
- {"criterion_text":"- Patients with known changes in BRAF, RET and NTRK cannot participate."}
- {"criterion_text":"- People with cancer that has spread to the brain or the lining of the brain and spinal cord cannot participate."}
- {"criterion_text":"- People with another type of cancer that needs treatment, or people with diseases where the body's immune system attacks its own cells, are also not allowed."}
- {"criterion_text":"- People who have been treated with certain drugs that affect the immune system, or who have had a heart condition called myocarditis, cannot participate."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Comparison of overall survival in Arm A and Arm B participants.","definition_or_measurement_approach":"Overall Survival (OS) comparison between Arm A and Arm B participants (OS as primary outcome)."}
Secondary endpoints
- {"endpoint_text":"- Comparison of PFS in Arm A and Arm B participant, as well as evaluation of DoR and ORR in Arm A and B participants.","definition_or_measurement_approach":"Progression-free survival (PFS); Duration of Response (DoR); Overall Response Rate (ORR) — comparisons between Arm A and Arm B."}
- {"endpoint_text":"- Safety of study drugs administered will be evaluated, along with TTD","definition_or_measurement_approach":"Safety assessments of study drugs in Arms A and B; Time to Deterioration (TTD) measured as specified in protocol."}
- {"endpoint_text":"- Comparison of PFS in Arm A and Arm B participant, as well as evaluation of DoR and ORR in Arm A and B participants.","definition_or_measurement_approach":"See above (PFS, DoR, ORR assessments)."}
Recruitment
- Planned Sample Size
- 712
- Recruitment Window Months
- 23
- Consent Approach
- Participants (aged ≥18) provide informed consent using subject information and informed consent forms. Country-specific ICFs and related documents are provided (multiple language versions present across submitted documents including German, English, French, Dutch, Polish, Portuguese, Italian and others). Additional ICF modules are available for topics such as pregnant partner information and optional future research.
Geography
- Total Number Of Sites
- 78
- Total Number Of Participants
- 288
Germany
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 288
- Number Of Sites
- 14
- Number Of Participants
- 50
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik (Tumorforschung)
- Principal Investigator Name
- Marcel Wiesweg
- Principal Investigator Email
- Marcel.Wiesweg@uk-essen.de
- Contact Person Name
- Marcel Wiesweg
- Contact Person Email
- Marcel.Wiesweg@uk-essen.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik & Poliklinik III
- Principal Investigator Name
- Peter Brossart
- Principal Investigator Email
- peter.brossart@ukbonn.de
- Contact Person Name
- Peter Brossart
- Contact Person Email
- peter.brossart@ukbonn.de
- Site Name
- Bundeswehrkrankenhaus Ulm
- Department Name
- Innere Medizin und Hämatologie und Onkologie
- Principal Investigator Name
- Matthias Müller
- Principal Investigator Email
- Matthias27Mueller@bundeswehr.org
- Contact Person Name
- Matthias Müller
- Contact Person Email
- Matthias27Mueller@bundeswehr.org
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Klinik für Innere Medizin - Hämatologie, Onkologie und Immunologie
- Principal Investigator Name
- Charis Faoro
- Principal Investigator Email
- faoro@staff.uni-marburg.de
- Contact Person Name
- Charis Faoro
- Contact Person Email
- faoro@staff.uni-marburg.de
- Site Name
- Universitaet Muenster
- Department Name
- Medizinische Klinik A (Hämatologie, Hämostaseologie, Onkologie und Pneumologie)
- Principal Investigator Name
- Annalen Bleckmann
- Principal Investigator Email
- annalen.bleckmann@ukmuenster.de
- Contact Person Name
- Annalen Bleckmann
- Contact Person Email
- annalen.bleckmann@ukmuenster.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- Onkologie
- Principal Investigator Name
- Martin Reck
- Principal Investigator Email
- m.reck@lungenclinic.de
- Contact Person Name
- Martin Reck
- Contact Person Email
- m.reck@lungenclinic.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinischen Klinik und Poliklinik V
- Principal Investigator Name
- Diego Kauffmann-Guerrero
- Principal Investigator Email
- diego.kauffmannguerrero@med.uni-muenchen.de
- Contact Person Name
- Diego Kauffmann-Guerrero
- Contact Person Email
- diego.kauffmannguerrero@med.uni-muenchen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Fächerverbund für Infektiologie, Pneumologie und Intensivmedizin
- Principal Investigator Name
- Nikolaj Frost
- Principal Investigator Email
- nikolaj.frost@charite.de
- Contact Person Name
- Nikolaj Frost
- Contact Person Email
- nikolaj.frost@charite.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Onkologie
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbH
- Department Name
- Klinik für Pneumologie und Infektiologie Sektion Thorakale Onkologie Ev. Krankenhaus Herne
- Principal Investigator Name
- Daniel Christoph
- Principal Investigator Email
- d.christoph@evk-herne.de
- Contact Person Name
- Daniel Christoph
- Contact Person Email
- d.christoph@evk-herne.de
- Site Name
- Klinikverbund Allgaeu gGmbH
- Department Name
- Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin
- Principal Investigator Name
- Christian Schumann
- Principal Investigator Email
- christian.schumann@kv-keoa.de
- Contact Person Name
- Christian Schumann
- Contact Person Email
- christian.schumann@kv-keoa.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Pneumologische Onkologie, Klinik für Kardiologie, Angiologie und Pneumologie
- Principal Investigator Name
- Martin Faehling
- Principal Investigator Email
- m.faehling@klinikum-esslingen.de
- Contact Person Name
- Martin Faehling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Innere Medizin IV
- Principal Investigator Name
- Stefan Hammerschmidt
- Principal Investigator Email
- s.hammerschmidt@skc.de
- Contact Person Name
- Stefan Hammerschmidt
- Contact Person Email
- s.hammerschmidt@skc.de
- Site Name
- Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der Heyde
- Department Name
- Onkologie
- Principal Investigator Name
- Eyck von der Heyde
- Principal Investigator Email
- vdheyde@onkologie-am-raschplatz.de
- Contact Person Name
- Eyck von der Heyde
- Contact Person Email
- vdheyde@onkologie-am-raschplatz.de
Romania
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 374
- Number Of Sites
- 7
- Number Of Participants
- 41
Sites
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- Oncology
- 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
- Institutul Regional De Oncologie Iasi
- Department Name
- Oncology
- Principal Investigator Name
- Dana Clement
- Principal Investigator Email
- dclement_6600@yahoo.com
- Contact Person Name
- Dana Clement
- Contact Person Email
- dclement_6600@yahoo.com
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncology
- Principal Investigator Name
- Aurelia Alexandru
- Principal Investigator Email
- auralexandru@yahoo.com
- Contact Person Name
- Aurelia Alexandru
- Contact Person Email
- auralexandru@yahoo.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- 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
- Memorial Healthcare International S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Ingrid Iordan
- Principal Investigator Email
- mireliordan@yahoo.com
- Contact Person Name
- Ingrid Iordan
- Contact Person Email
- mireliordan@yahoo.com
- Site Name
- Spitalul Municipal Ploiesti
- Department Name
- Oncology
- Principal Investigator Name
- Amedeia Nita
- Principal Investigator Email
- amedeianita@yahoo.com
- Contact Person Name
- Amedeia Nita
- Contact Person Email
- amedeianita@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- tudor_ciuleanu@hotmail.com
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 302
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Tallaght University Hospital
- Department Name
- Oncology Day Ward
- Principal Investigator Name
- Sebastian Trainor
- Principal Investigator Email
- RespiratoryAdmin@tuh.ie
- Contact Person Name
- Sebastian Trainor
- Contact Person Email
- RespiratoryAdmin@tuh.ie
- Site Name
- Beacon Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lisa Prior
- Principal Investigator Email
- Karen.Ryan@beaconhospital.ie
- Contact Person Name
- Lisa Prior
- Contact Person Email
- Karen.Ryan@beaconhospital.ie
- Site Name
- St James's Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Sinead Cuffe
- Principal Investigator Email
- research@stjames.ie
- Contact Person Name
- Sinead Cuffe
- Contact Person Email
- research@stjames.ie
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-05-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 289
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Rigshospitalet
- Department Name
- Dept. Oncology, Centre for Cancer and Organ Diseases/Afd 5073
- Principal Investigator Name
- Steen Riisgaard De Blanck
- Principal Investigator Email
- steen.riisgaard.de.blanck@regionh.dk
- Contact Person Name
- Steen Riisgaard De Blanck
- Contact Person Email
- steen.riisgaard.de.blanck@regionh.dk
- Site Name
- Sygehus Soenderjylland Soenderborg
- Department Name
- Oncology, Centre for Cancer and Organ Diseases/Afd 5073
- Principal Investigator Name
- Daniela Ztinjak
- Principal Investigator Email
- Daniela.Zitnjak@rsyd.dk
- Contact Person Name
- Daniela Ztinjak
- Contact Person Email
- Daniela.Zitnjak@rsyd.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Oncology
- Principal Investigator Name
- Pernille Byrialsen Elming
- Principal Investigator Email
- pernijen@rm.dk
- Contact Person Name
- Pernille Byrialsen Elming
- Contact Person Email
- pernijen@rm.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 294
- Number Of Sites
- 6
- Number Of Participants
- 35
Sites
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Principal Investigator Name
- Bogdan Zurawski
- Principal Investigator Email
- bzur1701@gmail.com
- Contact Person Name
- Bogdan Zurawski
- Contact Person Email
- bzur1701@gmail.com
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Marek Kotlarski
- Principal Investigator Email
- marek.kotlarski@pratia.com
- Contact Person Name
- Marek Kotlarski
- Contact Person Email
- marek.kotlarski@pratia.com
- Site Name
- Szpital Specjalistyczny W Prabutach Sp. z o.o.
- Department Name
- Oddzial Pulmonologii
- Principal Investigator Name
- Anna Lowczak
- Principal Investigator Email
- onkoania@gazeta.pl
- Contact Person Name
- Anna Lowczak
- Contact Person Email
- onkoania@gazeta.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- ewakalinka@wp.pl
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Lux Med Onkologia Sp. z o.o.
- Department Name
- Oddzial Onkologii Klinicznej/Chemioterapii
- Principal Investigator Name
- Ewa Salt
- Principal Investigator Email
- ewa.salt@luxmed.pl
- Contact Person Name
- Ewa Salt
- Contact Person Email
- ewa.salt@luxmed.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 312
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Oncology Department
- Principal Investigator Name
- Maria Cassiano Neves
- Principal Investigator Email
- maria.cassiano.neves@ipoporto.min-saude.pt
- Contact Person Name
- Maria Cassiano Neves
- Contact Person Email
- maria.cassiano.neves@ipoporto.min-saude.pt
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Pneumology Department
- Principal Investigator Name
- Catarina Sousa
- Principal Investigator Email
- catarina.da.sousa@chsj.min-saude.pt
- Contact Person Name
- Catarina Sousa
- Contact Person Email
- catarina.da.sousa@chsj.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pneumology Department
- Principal Investigator Name
- Ana Figueiredo
- Principal Investigator Email
- amrfigueiredo@gmail.com
- Contact Person Name
- Ana Figueiredo
- Contact Person Email
- amrfigueiredo@gmail.com
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Pneumology Department
- Principal Investigator Name
- Telma Sequeira
- Principal Investigator Email
- tsequeira@ipolisboa.min-saude.pt
- Contact Person Name
- Telma Sequeira
- Contact Person Email
- tsequeira@ipolisboa.min-saude.pt
France
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 305
- Number Of Sites
- 11
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de pneumologie et oncologie thoracique
- Principal Investigator Name
- Arnaud Scherpereel
- Principal Investigator Email
- arnaud.scherpereel@chru-lille.fr
- Contact Person Name
- Arnaud Scherpereel
- Contact Person Email
- arnaud.scherpereel@chru-lille.fr
- Site Name
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
- Department Name
- Service Oncologie
- Principal Investigator Name
- Clarisse Audigier-Valette
- Principal Investigator Email
- clarisse.audigier-valette@ch-toulon.fr
- Contact Person Name
- Clarisse Audigier-Valette
- Contact Person Email
- clarisse.audigier-valette@ch-toulon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Unité d'oncologie thoracique
- Principal Investigator Name
- Marie Wislez
- Principal Investigator Email
- marie.wislez@aphp.fr
- Contact Person Name
- Marie Wislez
- Contact Person Email
- marie.wislez@aphp.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Penumologie
- Principal Investigator Name
- Sophie Schneider
- Principal Investigator Email
- sschneider@ch-cotebasque.fr
- Contact Person Name
- Sophie Schneider
- Contact Person Email
- sschneider@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncology
- Principal Investigator Name
- Gilles QUERE
- Principal Investigator Email
- gilles.quere@chu-brest.fr
- Contact Person Name
- Gilles QUERE
- Contact Person Email
- gilles.quere@chu-brest.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service d'Oncologie Multidisciplinaire & Innovations thérapeutiques
- Principal Investigator Name
- Laurent Greillier
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Institut Curie
- Department Name
- Service d'oncologie thoracique
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- CHRU De Nancy
- Department Name
- Oncologie
- Principal Investigator Name
- Bertrand Mennecier
- Principal Investigator Email
- b.mennecier@chru-nancy.fr
- Contact Person Name
- Bertrand Mennecier
- Contact Person Email
- b.mennecier@chru-nancy.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Pneumologie Aiguë Spécialisée et Cancérologie thoracique
- Principal Investigator Name
- Sebastien Couraud
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sebastien Couraud
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumologie
- Principal Investigator Name
- Julien Mazieres
- Principal Investigator Email
- Mazieres.j@chu-toulouse.fr
- Contact Person Name
- Julien Mazieres
- Contact Person Email
- Mazieres.j@chu-toulouse.fr
- Site Name
- Centre Hospitalier De La Cote Basque (duplicate listing)
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 292
- Number Of Sites
- 6
- Number Of Participants
- 17
Sites
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pierre Freres
- Principal Investigator Email
- pfreres@chuliege.be
- Contact Person Name
- Pierre Freres
- Contact Person Email
- pfreres@chuliege.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Thoracic oncology
- Principal Investigator Name
- Reinier Wener
- Principal Investigator Email
- reinier.wener@uza.be
- Contact Person Name
- Reinier Wener
- Contact Person Email
- reinier.wener@uza.be
- Site Name
- UZ Brussel
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lore Decoster
- Principal Investigator Email
- lore.decoster@uzbrussel.be
- Contact Person Name
- Lore Decoster
- Contact Person Email
- lore.decoster@uzbrussel.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Pneumology
- Principal Investigator Name
- Ingel Demedts
- Principal Investigator Email
- ingel.demedts@azdelta.be
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Pulmonology & Thoracic Oncology
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- kristof.cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Department of Medicine - Division of Pulmonology
- Principal Investigator Name
- Sebahat Ocak
- Principal Investigator Email
- sebahat.ocak@chuuclnamur.uclouvain.be
- Contact Person Name
- Sebahat Ocak
- Contact Person Email
- sebahat.ocak@chuuclnamur.uclouvain.be
Austria
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 287
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Klinikum Wels-Grieskirchen GmbH
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Christian Trockenbacher
- Principal Investigator Email
- christian.trockenbacher@klinikum-wegr.at
- Contact Person Name
- Christian Trockenbacher
- Contact Person Email
- christian.trockenbacher@klinikum-wegr.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Internal Medicine and Pneumology
- Principal Investigator Name
- Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@wienkav.at
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@wienkav.at
- Site Name
- Universitaetsklinikum Krems
- Department Name
- Department of Pneumology
- Principal Investigator Name
- Klaus Hackner
- Principal Investigator Email
- Klaus.hackner@krems.lknoe.at
- Contact Person Name
- Klaus Hackner
- Contact Person Email
- Klaus.hackner@krems.lknoe.at
Spain
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 381
- Number Of Sites
- 11
- Number Of Participants
- 37
Sites
- Site Name
- Hospital Son Llatzer
- Department Name
- Oncology
- Principal Investigator Name
- Juan Coves Sarto
- Principal Investigator Email
- jcoves@hsll.es
- Contact Person Name
- Juan Coves Sarto
- Contact Person Email
- jcoves@hsll.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Pilar Garrido Lopez
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Pilar Garrido Lopez
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Maregarita Majem
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Maregarita Majem
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Arnau De Vilanova De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Nuria Piera
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Nuria Piera
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Ilaria Priano
- Principal Investigator Email
- ilariapriano@vhio.net
- Contact Person Name
- Ilaria Priano
- Contact Person Email
- ilariapriano@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Miriam Alonso Garcia
- Principal Investigator Email
- malonso.ec.huvr@gmail.com
- Contact Person Name
- Miriam Alonso Garcia
- Contact Person Email
- malonso.ec.huvr@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Provencio
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Mariano Provencio
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Cobo-Dols
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Manuel Cobo-Dols
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- María García Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- María García Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Paz-Ares
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Noelia Vilarino
- Principal Investigator Email
- nvilarino@iconcologia.net
- Contact Person Name
- Noelia Vilarino
- Contact Person Email
- nvilarino@iconcologia.net
Italy
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 349
- Number Of Sites
- 7
- Number Of Participants
- 22
Sites
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- U.O.C. Oncologia
- Principal Investigator Name
- Ferdinando Riccardi
- Principal Investigator Email
- ferdinando.riccardi@aocardarelli.it
- Contact Person Name
- Ferdinando Riccardi
- Contact Person Email
- ferdinando.riccardi@aocardarelli.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- SC Oncologia Falck
- Principal Investigator Name
- Elio Gregory Pizzutilo
- Principal Investigator Email
- eliogregory.pizzutilo@ospedaleniguarda.it
- Contact Person Name
- Elio Gregory Pizzutilo
- Contact Person Email
- eliogregory.pizzutilo@ospedaleniguarda.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- SSD Oncologia Medica per la Patologia Toracica
- Principal Investigator Name
- Domenico Galetta
- Principal Investigator Email
- galetta@oncologico.bari.it
- Contact Person Name
- Domenico Galetta
- Contact Person Email
- galetta@oncologico.bari.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia Medica 2
- Principal Investigator Name
- Gabriele Minuti
- Principal Investigator Email
- gabriele.minuti@ifo.it
- Contact Person Name
- Gabriele Minuti
- Contact Person Email
- gabriele.minuti@ifo.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Dip Onco-Ematologico
- Principal Investigator Name
- Manolo D'Arcangelo
- Principal Investigator Email
- manolo.darcangelo@auslromagna.it
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
- Department Name
- LUNG-UNIT TORACIC
- Principal Investigator Name
- Antonio Santo
- Principal Investigator Email
- antonio.santo@ospedalepederzoli.it
- Contact Person Name
- Antonio Santo
- Contact Person Email
- antonio.santo@ospedalepederzoli.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- U.O.C Pneumologia Oncologica
- Principal Investigator Name
- Danilo Rocco
- Principal Investigator Email
- danilorocc@yahoo.it
- Contact Person Name
- Danilo Rocco
- Contact Person Email
- danilorocc@yahoo.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 350
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Department of Pulmonary Medicine
- Principal Investigator Name
- Niels Claessens
- Principal Investigator Email
- NClaessens@rijnstate.nl
- Contact Person Name
- Niels Claessens
- Contact Person Email
- NClaessens@rijnstate.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Egbert Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- Egbert Smit
- Contact Person Email
- e.f.smit@lumc.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Pulmonology
- Principal Investigator Name
- Frank Custers
- Principal Investigator Email
- f.custers@zuyderland.nl
- Contact Person Name
- Frank Custers
- Contact Person Email
- f.custers@zuyderland.nl
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Iqvia Holdings Inc.
- Responsibilities
- Multiple operational responsibilities including SUSAR reporting and other clinical trial support (sponsor duties entries include SUSAR reporting and other codes).
- Name
- Signant Health Global LLC
- Responsibilities
- IVRS – treatment randomisation; Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment, PRO/COA
- Name
- Clario
- Responsibilities
- Medical image analysis/review; Customer Care / Site Logistics / Training / Equipment Customization
- Name
- Labcorp (various Labcorp entities)
- Responsibilities
- Central and routine clinical laboratory testing, IHC and biomarker analyses, tumor blocks/slides storage and related laboratory services.
- Name
- Axio
- Responsibilities
- Independent generation of partially unblinded & blinded tables, listings, profiles, analyses for DMC
Third parties
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"Specialty Biomarker Testing Lab for HLA Alleles","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp | Center for Molecular Biology and Pathology","duties_or_roles":"Routine clinical pathology testing; Clinical chemistry; Clinical haematology; Clinical microbiology; Speciality Biomarker Testing","organisation_type":"Health care"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing; Clinical chemistry; Clinical haematology; Clinical microbiology; Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing; Clinical chemistry; Clinical haematology; Clinical microbiology; IHC Biomarker expression analysis (PD-L1), other APH","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistic Validation Services","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS – treatment randomisation; Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Multiple operational tasks including SUSAR reporting and other trial support (codes referenced in sponsor duties)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review; Customer Care / Site Logistics / Training / Equipment Customization","organisation_type":"Health care"}
- {"country":"United States","full_name":"Axio","duties_or_roles":"Independent - generate partially unblinded & blinded tables, listings, pt profiles, analyses for DMC","organisation_type":"Industry"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Analyzing lab to generate exploratory IHC PDL1/CD8/LAG3 Triplex data","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Locate lost and follow-up subjects","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Relatlimab + Nivolumab Fixed Dose Combination (FDC)
- Active Substance
- NIVOLUMAB, RELATLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- PEMETREXED DISODIUM
- Active Substance
- PEMETREXED DISODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Combination Treatment
- Yes
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