Clinical trial • Phase III • Oncology
Tarlatamab for Extensive-stage small cell lung cancer
Phase III trial of Tarlatamab for Extensive-stage small cell lung cancer. 104 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive-stage small cell lung cancer
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 23-08-2024
Trial design
Phase III trial across 15 sites in Belgium, France, Germany and others.
- Target Sample Size
- 104
Eligibility
Recruits 104 Vulnerable population selected; no details provided on consent or assent handling..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling.
Recruitment
- Planned Sample Size
- 104
- Recruitment Window Months
- 75
- Consent Approach
- Not specified; no details on informed consent or assent process provided.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 80
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 534
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- 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
- Az Maria Middelares Gent
- Department Name
- Pneumologie
- Principal Investigator Name
- Paul Germonpré
- Principal Investigator Email
- paul.germonpre@mijnziekenhuis.be
- Contact Person Name
- Paul Germonpré
- Contact Person Email
- paul.germonpre@mijnziekenhuis.be
- Site Name
- Antwerp University Hospital
- Department Name
- Oncologie
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Respiratoire Oncologie
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- Kristof.Cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- Kristof.Cuppens@jessazh.be
France
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 532
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement d'Innovation Therapeutique et d'Essais Précoces
- Principal Investigator Name
- Kaissa Ouali
- Principal Investigator Email
- kaissa.ouali@gustaveroussy.fr
- Contact Person Name
- Kaissa Ouali
- Contact Person Email
- kaissa.ouali@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Service de Cancerologie Medicale
- Principal Investigator Name
- Aurelie Swalduz
- Principal Investigator Email
- aurelie.swalduz@lyon.unicancer.fr
- Contact Person Name
- Aurelie Swalduz
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service Pneumologie, Institut du thorax
- Principal Investigator Name
- Elvira Pons-Tostivint
- Principal Investigator Email
- elvire.pons@chu-nantes.fr
- Contact Person Name
- Elvira Pons-Tostivint
- Contact Person Email
- elvire.pons@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 543
- Number Of Sites
- 3
- Number Of Participants
- 27
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Tumorbiologie
- 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
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik (Tumorforschung)
- Principal Investigator Name
- Michael Pogorzelski
- Principal Investigator Email
- Michael.Pogorzelski@uk-essen.de
- Contact Person Name
- Michael Pogorzelski
- Contact Person Email
- Michael.Pogorzelski@uk-essen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Early Clinical Trial Unit - Universitaetskrebszentrum
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
Italy
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 501
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Unità Operativa Oncologia Medica
- Principal Investigator Name
- Diego Luigi Cortinovis
- Principal Investigator Email
- diegoluigi.cortinovis@irccs-sangerardo.it
- Contact Person Name
- Diego Luigi Cortinovis
- Contact Person Email
- diegoluigi.cortinovis@irccs-sangerardo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 542
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Pedro Filipe Simões Da Rocha
- Principal Investigator Email
- pedrorocha@vhio.net
- Contact Person Name
- Pedro Filipe Simões Da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Enric Carcereny Costa
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 539
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonary medicine
- Principal Investigator Name
- Jeroen Hiltermann
- Principal Investigator Email
- t.j.n.hiltermann@umcg.nl
- Contact Person Name
- Jeroen Hiltermann
- Contact Person Email
- t.j.n.hiltermann@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Tarlatamab
- Active Substance
- Tarlatamab
- Investigational Product Name
- Carboplatin
- Active Substance
- Carboplatin
- Investigational Product Name
- Etoposide
- Active Substance
- Etoposide
- Investigational Product Name
- PD-L1 inhibitor
- Combination Treatment
- Yes
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