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
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

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
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

Related trials

Other published trials that may interest you.