Clinical trial • Phase I/II • Oncology
Tarlatamab for Small cell lung cancer|Small cell lung cancer, extensive stage
Phase I/II trial of Tarlatamab for Small cell lung cancer|Small cell lung cancer, extensive stage. 107 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer|Small cell lung cancer, extensive stage
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|Other|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Phase I/II trial across 14 sites in Belgium, France, Germany and others.
- Target Sample Size
- 107
Eligibility
Recruits 107 Vulnerable population selected; no details on consent/assent handling available in provided documents..
- Vulnerable Population
- Vulnerable population selected; no details on consent/assent handling available in provided documents.
Recruitment
- Planned Sample Size
- 107
- Recruitment Window Months
- 61
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 44
Belgium
France
- Earliest CTIS Part Ii Submission Date
- 15-04-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 20
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pulmonology Department
- Contact Person Name
- Michael Duruisseaux
- Contact Person Email
- michael.duruisseaux@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Early Drug Development Department (DITEP)
- Contact Person Name
- Anas Gazzah
- Contact Person Email
- anas.gazzah@gustaveroussy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Marseille Early Phase Oncology Clinical Trials Unit
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 09-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Comprehensive Cancer Center Mainfranken
- Contact Person Name
- Horst-Dieter Hummel
- Contact Person Email
- isz_koordination@ukw.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- NCT Early Clinical Trial Unit
- Contact Person Name
- Martin Wermke
- Contact Person Email
- ectu@ukdd.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hematology, oncology and tumor immunology
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
Spain
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 10-05-2026
- Processing Time Days
- 30
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Hematologia y Oncologia
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Pedro Filipe Simoes Da Rocha
- Contact Person Email
- pedrorocha@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Maria Eugenia Olmedo Garcia
- Contact Person Email
- maruolmedogarcia@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Servicio de Oncologia
- Contact Person Name
- Jose Carlos Benitez Montañez
- Contact Person Email
- josecarlos.benitez@ibima.eu
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 17-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Contact Person Name
- Katarzyna Drosik-Rutowicz
- Contact Person Email
- Katarzyna.drosik-rutowicz@gliwice.nio.gov.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- Dariusz.Kowalski@nio.gov.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Oncology
- Contact Person Name
- Hanna Liberek
- Contact Person Email
- obkwf@uck.gda.pl
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Tarlatamab
- Modality
- Bispecific antibody
- Investigational Product Name
- ZL-1310
- Modality
- Other
- Investigational Product Name
- Anti-PD-L1
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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