Clinical trial • Phase III • Oncology
AMG 193 for Thoracic tumors with homozygous MTAP-deletion | Non-small cell lung cancer
Phase III trial of AMG 193 for Thoracic tumors with homozygous MTAP-deletion | Non-small cell lung cancer. 58 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Thoracic tumors with homozygous MTAP-deletion | Non-small cell lung cancer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 16-04-2024
- First CTIS Authorization Date
- 29-07-2024
Trial design
Phase III trial across 28 sites in France, Spain, Germany and others.
- Target Sample Size
- 58
Eligibility
Recruits 58 Vulnerable population not selected; no specific consent/assent details provided..
- Vulnerable Population
- Vulnerable population not selected; no specific consent/assent details provided.
Recruitment
- Planned Sample Size
- 58
- Recruitment Window Months
- 43
- Consent Approach
- Not specified in provided data; informed consent process not described.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 42
France
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 573
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Service d'Oncologie Multidisciplinaire et Innovation Thérapeutiques
- Contact Person Name
- Benjamin Besse
- Contact Person Email
- benjamin.besse@gustaveroussy.fr
- Site Name
- Institut Bergonie
- Department Name
- Service d'Oncologie Médicale
- Contact Person Name
- Sophie Cousin
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Service Oncologie
- Contact Person Name
- Sandrine Hiret
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d'Essais Précoces de Cancérologie de Marseille
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 604
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Oncologia Medica
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- nreguart@clinic.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 598
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoraxklinik Heidelberg gGmbH
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Halime Kalkavan
- Contact Person Email
- Halime.Kalkavan@uk-essen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Comprehensive Cancer Center Mainfranken (CCCM)
- Contact Person Name
- Horst-Dieter Hummel
- Contact Person Email
- isz_koordination@ukw.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 609
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Pneumologie
- Contact Person Name
- Astrid Paulus
- Contact Person Email
- apaulus@chuliege.be
Poland
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 22-02-2026
- Processing Time Days
- 608
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Oncology
- Contact Person Name
- Hanna Liberek
- Contact Person Email
- obkwf@uck.gda.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- Oncology
- Contact Person Name
- Michal Parkitny
- Contact Person Email
- michal.parkitny@futuremeds.com
- Site Name
- Centrum Medyczne Hope Clinic Sebastian Szklener
- Department Name
- Oncology
- Contact Person Name
- Katarzyna Szklener
- Contact Person Email
- cmhopeclinic@gmail.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Contact Person Name
- Katarzyna Drosik-Rutowicz
- Contact Person Email
- CWBK@gliwice.nio.gov.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Oncology
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- grubiak.marta@gmail.com
Austria
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 596
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Internal Medicine V
- Contact Person Name
- Andreas Pircher
- Contact Person Email
- andreas.pircher@tirol-kliniken.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Internal Medicine
- Contact Person Name
- Gudrun Absenger
- Contact Person Email
- gudrun.absenger@medunigraz.at
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 572
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Medical Oncology
- Contact Person Name
- Ingrid Desar
- Contact Person Email
- Ingrid.Desar@radboudumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 677
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 1
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Dipartimento di Ematologia ed Oncologia
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica ed Ematologia
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@hunimed.eu
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro di Ricerche Cliniche
- Contact Person Name
- Jessica Menis
- Contact Person Email
- jessica.menis@aovr.veneto.it
Greece
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 706
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4™ Oncology dept. & Clinical Trials Unit
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- Alexandra Hospital
- Department Name
- Oncology Department / Department of Clinical Therapeutics
- Contact Person Name
- Michalis Liontos
- Contact Person Email
- mliontos@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Molecular Medicine Clinic/Clinical Trial Unit
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AMG 193
- Combination Treatment
- Yes
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