Clinical trial • Phase III • Oncology
NIVOLUMAB, ATIGOTATUG for Extensive-stage small cell lung cancer
Phase III trial of NIVOLUMAB, ATIGOTATUG for Extensive-stage small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive-stage small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 31-10-2024
- First CTIS Authorization Date
- 10-03-2025
Trial design
Randomised, atezolizumab in combination with carboplatin plus etoposide (intravenous); specific doses and schedule not specified in the record.-controlled Phase III trial in France, Romania, Netherlands and others.
- Randomised
- Yes
- Comparator
- Atezolizumab in combination with Carboplatin plus Etoposide (intravenous); specific doses and schedule not specified in the record.
- Target Sample Size
- 318
Eligibility
Recruits 318 isVulnerablePopulationSelected is false; no special vulnerable population consent/assent procedures specified in the record..
- Vulnerable Population
- isVulnerablePopulationSelected is false; no special vulnerable population consent/assent procedures specified in the record.
Inclusion criteria
- {"criterion_text":"-Diagnosis of ES-SCLC\n-Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.\n-At least one tumour that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system."}
Exclusion criteria
- {"criterion_text":"-People have already received certain types of treatment for extensive stage small cell lung cancer.\n-People have certain health conditions, like spread of small cell lung cancer to the brain and meninges that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Overall survival: how long participants live after entering the study (i.e. after randomization)","definition_or_measurement_approach":"Overall survival: how long participants live after entering the study (i.e. after randomization)"}
Secondary endpoints
- {"endpoint_text":"-Time for disease related symptoms to get worse (TTDD).","definition_or_measurement_approach":"Time for disease related symptoms to get worse (TTDD)."}
- {"endpoint_text":"-Safety: side effects, the number of side effects, type, severity, seriousness, and outcome.","definition_or_measurement_approach":"Safety: side effects, the number of side effects, type, severity, seriousness, and outcome."}
- {"endpoint_text":"-Response: measurements to indicate how many patients' tumors shrink or disappear after treatment (Overall Response).","definition_or_measurement_approach":"Response: measurements to indicate how many patients' tumors shrink or disappear after treatment (Overall Response)."}
- {"endpoint_text":"-How long the tumors stay shrunk or disappear (Duration of Response)","definition_or_measurement_approach":"How long the tumors stay shrunk or disappear (Duration of Response)."}
- {"endpoint_text":"-The time during and after treatment that a participant lives without their disease getting worse (Progression Free Survival).","definition_or_measurement_approach":"The time during and after treatment that a participant lives without their disease getting worse (Progression Free Survival)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 318
- Recruitment Window Months
- 77
- Consent Approach
- Informed consent obtained from participants using country- and language-specific L1 SIS and ICF documents. Multiple language versions of the ICFs are available (examples in the record include English, French, Dutch, German, Italian, Spanish, Polish, Czech, Greek). ICF packages include optional modules (pregnant participant/partner, treatment beyond progression, optional future research). Consent is provided by the participant; no assent/parental consent for minors is specified.
Methods
- Country-specific recruitment arrangements (K1 documents) and recruitment brochures/PI-to-patient letters (K2) are provided as listed in CTIS documents.
- Use of recruitment brochures and PI-to-patient letters (K2) to inform potential participants.
- Social media recruitment statement documented for Germany (K2_Recruitment Material_Social Media Statement_DE).
Geography
- Total Number Of Sites
- 68
- Total Number Of Participants
- 212
France
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 234
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncologie Multidisciplinaire et 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
- Centre Hospitalier Universitaire De Lille
- Department Name
- 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
- Institut Gustave Roussy
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Pernelle LAVAUD
- Principal Investigator Email
- pernelle.lavaud@gustaveroussy.fr
- Contact Person Name
- Pernelle LAVAUD
- Contact Person Email
- pernelle.lavaud@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Oncologie Thoracique
- Principal Investigator Name
- Benoit ROCH
- Principal Investigator Email
- b-roch@chu-montpellier.fr
- Contact Person Name
- Benoit ROCH
- Contact Person Email
- b-roch@chu-montpellier.fr
- Site Name
- Institut Curie
- Department Name
- Pneumologie
- 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
- Les Hopitaux Nord-Ouest
- Department Name
- Pneumologie
- Principal Investigator Name
- Lionel Falchero
- Principal Investigator Email
- lfalchero@lhopitalnordouest.fr
- Contact Person Name
- Lionel Falchero
- Contact Person Email
- lfalchero@lhopitalnordouest.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Pôle Thorax et Vaisseaux Service universitaire de Pneumologie Unité d'oncologie Thoracique
- Principal Investigator Name
- Denis MORO-SIBILOT
- Principal Investigator Email
- pirechoncothoracique@chu-grenoble.fr
- Contact Person Name
- Denis MORO-SIBILOT
- Contact Person Email
- pirechoncothoracique@chu-grenoble.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumologie Oncologie thoracique
- Principal Investigator Name
- Christos CHOUAID
- Principal Investigator Email
- christos.chouaid@chicreteil.fr
- Contact Person Name
- Christos CHOUAID
- Contact Person Email
- christos.chouaid@chicreteil.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Pneumologie Oncologie
- Principal Investigator Name
- Romain CORRE
- Principal Investigator Email
- romain.corre@ch-cornouaille.fr
- Contact Person Name
- Romain CORRE
- Contact Person Email
- romain.corre@ch-cornouaille.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pneumologie
- Principal Investigator Name
- Sébastien COURAUD
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastien COURAUD
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
Romania
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 286
- Number Of Sites
- 7
- Number Of Participants
- 25
Sites
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Dana Clement
- Principal Investigator Email
- manager@iroiasi.ro
- Contact Person Name
- Dana Clement
- Contact Person Email
- manager@iroiasi.ro
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Andrei Ungureanu
- Principal Investigator Email
- office.cluj@amethyst-radiotherapy.ro
- Contact Person Name
- Andrei Ungureanu
- Contact Person Email
- office.cluj@amethyst-radiotherapy.ro
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- office@centruldeoncologie.ro
- Contact Person Name
- Michael Schenker
- Contact Person Email
- office@centruldeoncologie.ro
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Constantin Volovat
- Principal Investigator Email
- xyz@gmail.com
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- xyz@gmail.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- 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
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Aurelia Alexandru
- Principal Investigator Email
- secretariat@iob.ro
- Contact Person Name
- Aurelia Alexandru
- Contact Person Email
- secretariat@iob.ro
- Site Name
- Memorial Healthcare International S.R.L.
- Department Name
- Ongologie Medicala
- Principal Investigator Name
- Ingid Adriana Iordan
- Principal Investigator Email
- info@memorial.ro
- Contact Person Name
- Ingid Adriana Iordan
- Contact Person Email
- info@memorial.ro
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-02-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 196
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Lung
- Principal Investigator Name
- Idris Bahce
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Idris Bahce
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Lung
- Principal Investigator Name
- Jeroen Hiltermann
- Principal Investigator Email
- iloaoc@umcg.nl
- Contact Person Name
- Jeroen Hiltermann
- Contact Person Email
- iloaoc@umcg.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Lung
- Principal Investigator Name
- Niels Claessens
- Principal Investigator Email
- researchlong@rijnstate.nl
- Contact Person Name
- Niels Claessens
- Contact Person Email
- researchlong@rijnstate.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-02-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 200
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pneumology
- Principal Investigator Name
- Veerle Surmont
- Principal Investigator Email
- veerle.surmont@uzgent.be
- Contact Person Name
- Veerle Surmont
- Contact Person Email
- veerle.surmont@uzgent.be
- Site Name
- Vitaz
- Department Name
- Pulmonary and infectious diseases
- Principal Investigator Name
- Koenraad Deschepper
- Principal Investigator Email
- koen.deschepper@vitaz.be
- Contact Person Name
- Koenraad Deschepper
- Contact Person Email
- koen.deschepper@vitaz.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pneumology
- Principal Investigator Name
- Frank Aboubakar
- Principal Investigator Email
- frank.aboubakar@uclouvain.be
- Contact Person Name
- Frank Aboubakar
- Contact Person Email
- frank.aboubakar@uclouvain.be
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- Pneumology
- Principal Investigator Name
- Anne Sibille
- Principal Investigator Email
- anne.sibille@chuliege.be
- Contact Person Name
- Anne Sibille
- Contact Person Email
- anne.sibille@chuliege.be
Italy
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 224
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Thoracic oncology Division
- Principal Investigator Name
- Filippo De Marinis
- Principal Investigator Email
- filippo.demarinis@ieo.it
- Contact Person Name
- Filippo De Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Giulio Metro
- Principal Investigator Email
- giulio.metro@unipeg.it
- Contact Person Name
- Giulio Metro
- Contact Person Email
- giulio.metro@unipeg.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology 1
- Principal Investigator Name
- Giuseppe Lo Russo
- Principal Investigator Email
- giuseppe.lorusso@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Lo Russo
- Contact Person Email
- giuseppe.lorusso@istitutotumori.mi.it
- Site Name
- Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
- Department Name
- U.O. di Oncologia Toracica, Lung Unit
- 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
- 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 Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Oncology hematology department
- Principal Investigator Name
- Francesco Gelsomino
- Principal Investigator Email
- francesco_gelsomino@aosp.bo.it
- Contact Person Name
- Francesco Gelsomino
- Contact Person Email
- francesco_gelsomino@aosp.bo.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- thoracopulmonary department
- Principal Investigator Name
- Alessandro Morabito
- Principal Investigator Email
- a.morabito@istitutotumori.na.it
- Contact Person Name
- Alessandro Morabito
- Contact Person Email
- a.morabito@istitutotumori.na.it
Spain
- Earliest CTIS Part Ii Submission Date
- 15-01-2025
- Latest Decision Or Authorization Date
- 28-08-2025
- Processing Time Days
- 225
- Number Of Sites
- 10
- Number Of Participants
- 31
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Reyes Bernabe
- Principal Investigator Email
- bernabeensayos@gmail.com
- Contact Person Name
- Reyes Bernabe
- Contact Person Email
- bernabeensayos@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Maria Eugenia Olmedo
- Principal Investigator Email
- xxxxxx@xxxx.com
- Contact Person Name
- Maria Eugenia Olmedo
- Contact Person Email
- xxxxxx@xxxx.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Jorge Garcia
- Principal Investigator Email
- jorge.jose.garcia.gonzalez@sergas.es
- Contact Person Name
- Jorge Garcia
- Contact Person Email
- jorge.jose.garcia.gonzalez@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Margarita Majem
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Alejandro Navarro
- Principal Investigator Email
- afnavarro@clinic.cat
- Contact Person Name
- Alejandro Navarro
- Contact Person Email
- afnavarro@clinic.cat
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Principal Investigator Name
- Ana Ortega
- Principal Investigator Email
- xxxx@xxx.com
- Contact Person Name
- Ana Ortega
- Contact Person Email
- xxxx@xxx.com
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Paula Espinosa
- Principal Investigator Email
- xxxxxx@xxx.com
- Contact Person Name
- Paula Espinosa
- Contact Person Email
- xxxxxx@xxx.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Paz-Ares
- Principal Investigator Email
- xxxxx@xxxx.com
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- xxxxx@xxxx.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Provencio
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Principal Investigator Name
- David Vicente
- Principal Investigator Email
- xxxx@xxx.com
- Contact Person Name
- David Vicente
- Contact Person Email
- xxxx@xxx.com
Poland
- Earliest CTIS Part Ii Submission Date
- 11-02-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 202
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- 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
- 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
- Pratia S.A.
- Department Name
- Centrum Medyczne Pratia Poznań
- 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
- Przychodnia Lekarska KOMED
- Principal Investigator Name
- Bogusława Karaszewska
- Principal Investigator Email
- komed.badania@gmail.com
- Contact Person Name
- Bogusława Karaszewska
- Contact Person Email
- komed.badania@gmail.com
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- ambulatorium.chemioterapii@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- ambulatorium.chemioterapii@co.bydgoszcz.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 190
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Oddeleni C - oddeleni klinicke onkologie
- Principal Investigator Name
- Jan Podhorec
- Principal Investigator Email
- jan.podhorec@mou.cz
- Contact Person Name
- Jan Podhorec
- Contact Person Email
- jan.podhorec@mou.cz
- Site Name
- Nemocnice AGEL Ostrava-Vitkovice a.s.
- Department Name
- Plicni oddeleni
- Principal Investigator Name
- Jaromir Roubec
- Principal Investigator Email
- jaromir.roubec@vtn.agel.cz
- Contact Person Name
- Jaromir Roubec
- Contact Person Email
- jaromir.roubec@vtn.agel.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Klinika plicnich nemoci a tuberkulozy
- Principal Investigator Name
- Juraj Kultan
- Principal Investigator Email
- juraj.kultan@fnol.cz
- Contact Person Name
- Juraj Kultan
- Contact Person Email
- juraj.kultan@fnol.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Pneumologicka klinika 1. LF UK a FTN
- Principal Investigator Name
- Marketa Cernovska
- Principal Investigator Email
- marketa.cernovska@ftn.cz
- Contact Person Name
- Marketa Cernovska
- Contact Person Email
- marketa.cernovska@ftn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 12-02-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 301
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoraxonkologie
- Principal Investigator Name
- Michael Thomas
- Principal Investigator Email
- michael.thomas@med.uni-heidelberg.de
- Contact Person Name
- Michael Thomas
- Contact Person Email
- michael.thomas@med.uni-heidelberg.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- Onkologie
- Principal Investigator Name
- Martin Reck
- Principal Investigator Email
- a.gaebler@lungenclinic.de
- Contact Person Name
- Martin Reck
- Contact Person Email
- a.gaebler@lungenclinic.de
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- Lungenkrebszentrum
- Principal Investigator Name
- Eva Lotte Buchmaier
- Principal Investigator Email
- buchmeiere@kliniken-koeln.de
- Contact Person Name
- Eva Lotte Buchmaier
- Contact Person Email
- buchmeiere@kliniken-koeln.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Klinik für Hämatologie und Onkologie
- Principal Investigator Name
- Frank Griesinger
- Principal Investigator Email
- frank.griesinger@pius-hospital.de
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Thorakale 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
- Zentralklinik Bad Berka GmbH
- Department Name
- Internistische Hämatologie und Onkologie
- 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
- Krankenhaus Nordwest GmbH
- Department Name
- Thoraxonkologie
- Principal Investigator Name
- Akin Atmaca
- Principal Investigator Email
- atmaca.akin@khnw.de
- Contact Person Name
- Akin Atmaca
- Contact Person Email
- atmaca.akin@khnw.de
- Site Name
- Robert Bosch Gesellschaft fuer medizinische Forschung mbH
- Department Name
- Robert Bosch Krankenhaus Lungenzentrum
- Principal Investigator Name
- Martin Kimmich
- Principal Investigator Email
- martin.kimmich@rbk.de
- Contact Person Name
- Martin Kimmich
- Contact Person Email
- martin.kimmich@rbk.de
- Site Name
- Martha-Maria Krankenhaus Halle-Doelau gGmbH
- Department Name
- Studiensekretariat, MVZ, E0
- Principal Investigator Name
- Miriam Möller
- Principal Investigator Email
- miriam.moeller@martha-maria.de
- Contact Person Name
- Miriam Möller
- Contact Person Email
- miriam.moeller@martha-maria.de
Austria
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 23-11-2025
- Processing Time Days
- 264
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Klinikum Wels-Grieskirchen GmbH
- Department Name
- Department for Lung Diseases
- Principal Investigator Name
- Philipp Vinatzer
- Principal Investigator Email
- philipp.vinatzer@klinikum-wegr.at
- Contact Person Name
- Philipp Vinatzer
- Contact Person Email
- philipp.vinatzer@klinikum-wegr.at
- Site Name
- Landeskrankenhaus Rankweil
- Department Name
- Department for Internal Medicine II
- Principal Investigator Name
- Thomas Winder
- Principal Investigator Email
- thomas.winder@lkhf.at
- Contact Person Name
- Thomas Winder
- Contact Person Email
- thomas.winder@lkhf.at
- Site Name
- Medical University Of Graz
- Department Name
- Clinical Department for Pneumology
- Principal Investigator Name
- Nikolaus Kneidinger
- Principal Investigator Email
- nikolaus.kneidinger@medunigraz.at
- Contact Person Name
- Nikolaus Kneidinger
- Contact Person Email
- nikolaus.kneidinger@medunigraz.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Internal Medicine 4 - Pneumology
- Principal Investigator Name
- David Lang
- Principal Investigator Email
- david.lang@kepleruniklinikum.at
- Contact Person Name
- David Lang
- Contact Person Email
- david.lang@kepleruniklinikum.at
Greece
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 484
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Oncology Department and Clinical Trials Unit
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- 2nd Department of Oncology Clinic
- Principal Investigator Name
- Anastasios Boutis
- Principal Investigator Email
- alboutis@otenet.gr
- Contact Person Name
- Anastasios Boutis
- Contact Person Email
- alboutis@otenet.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- Oncology Clinic, Chemotherapy 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
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Sofia Baka
- Principal Investigator Email
- bakasofia@hotmail.com
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Department of Internal Medicine, Oncology Unit & Laboratory
- Principal Investigator Name
- Konstantinos Syrigos
- Principal Investigator Email
- ksyrigos.trials@gmail.com
- Contact Person Name
- Konstantinos Syrigos
- Contact Person Email
- ksyrigos.trials@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Analysis of ADA and pK samples and data transfers
- Name
- Iqvia Inc.
- Responsibilities
- Site Payments for Contracted Clinical Trial Activities
- Name
- Endpoint Clinical Inc.
- Responsibilities
- IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
Third parties
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations; Pharmacovigilance: Medical review & Cases Data Entry; (other duties listed across entries include code-only entries without descriptive text)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Analysis of ADA and pK samples and data transfers","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/COA design, translations, tablet supply to sites, data management, and data transfers","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments for Contracted Clinical Trial Activities","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumour blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS – treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"(additional Accenture entry - duties code-only entry present)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Atigotatug + Nivolumab FDC
- Active Substance
- NIVOLUMAB, ATIGOTATUG
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 1
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Maximum Dose
- 3000
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Investigational Product Name
- ATEZOLIZUMAB
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Maximum Dose
- 1680
- Combination Treatment
- Yes
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