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.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Extensive-stage small cell lung cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Monoclonal antibody|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
16-05-2025
First CTIS Authorization Date
01-09-2025

Trial design

Randomised, open-label, investigational group: tarlatamab + durvalumab + carboplatin + etoposide; control group: durvalumab + carboplatin + etoposide Phase III trial in Spain, France, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigational Group: Tarlatamab + Durvalumab + Carboplatin + Etoposide; Control Group: Durvalumab + Carboplatin + Etoposide
Target Sample Size
202

Eligibility

Recruits 202 Vulnerable populations not selected. Informed consent must be provided by the participant prior to any study-specific activities; participants must be ≥18 years (or legal age in country). Consent and subject information/ICF documents are provided (L1_SIS and ICF materials) and country/language-specific ICFs are available per participating country..

Pregnancy Exclusion
Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
Vulnerable Population
Vulnerable populations not selected. Informed consent must be provided by the participant prior to any study-specific activities; participants must be ≥18 years (or legal age in country). Consent and subject information/ICF documents are provided (L1_SIS and ICF materials) and country/language-specific ICFs are available per participating country.

Inclusion criteria

  • {"criterion_text":"-Participant has provided informed consent before initiation of any study-specific activities/procedures."}
  • {"criterion_text":"-Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years."}
  • {"criterion_text":"-Histologically or cytologically documented extensive-stage small-cell lung cancer (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan."}
  • {"criterion_text":"-Measurable disease as defined per RECIST 1.1"}
  • {"criterion_text":"-No prior treatment for SCLC. NOTE: (see section 5.1 of the Protocol for additional details)"}
  • {"criterion_text":"-Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment."}
  • {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1."}
  • {"criterion_text":"-Minimum life expectancy ≥ 12 weeks."}
  • {"criterion_text":"-Adequate organ function, defined as follows:  Hematological function: o Absolute neutrophil count ≥ 1.5 x 10^9/L o Platelet count ≥ 100 x 10^9/L o Hemoglobin ≥ 9 g/dL (90 g/L)  Coagulation function: o Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 2 weeks prior to randomization  Renal function: o Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 60 mL/min/1.73 m2  Hepatic function: o aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN for participants with liver involvement) o Total bilirubin (TBL) ≤ 1.5 x ULN (or ≤ 2 x ULN for participants with liver involvement), with the exception of participants with Gilbert's disease  Pulmonary function: o No oxygen supplementation  Cardiac function: o Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) [or multigated acquisition (MUGA) scan if ECHO is not available], and no electrocardiogram (ECG) finding related to acute/subacute myocardial ischemia and/or clinically significant arrythmia."}

Exclusion criteria

  • {"criterion_text":"-Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease."}
  • {"criterion_text":"-Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment."}
  • {"criterion_text":"-History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment."}
  • {"criterion_text":"-Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis."}
  • {"criterion_text":"-History of solid organ transplant."}
  • {"criterion_text":"-Major surgical procedures within XX days prior to first dose of study treatment."}
  • {"criterion_text":"-Presence of active HIV or active hepatitis infection."}
  • {"criterion_text":"-Has received or is planning to receive consolidative chest radiation, for extensive-stage disease."}
  • {"criterion_text":"-Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the DLL3 pathway."}
  • {"criterion_text":"-Treatment in an alternative investigational trial within XX days prior to enrollment."}
  • {"criterion_text":"-Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-History of allergic reactions or acute hypersensitivity reactions to antibody therapies, carboplatin, etoposide or pegfilgrastim."}
  • {"criterion_text":"-Participants who are breastfeeding or who plan to breastfeed while on study through (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-Participants planning to become pregnant while on study through (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test."}
  • {"criterion_text":"-Participants with a partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-Participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-Participants unwilling to abstain from donating sperm during treatment and for an additional (see Protocol section 5.2 for details)."}
  • {"criterion_text":"-Participant has known sensitivity to any of the products or components to be administered during dosing."}
  • {"criterion_text":"-Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the Participant and investigator’s knowledge. Participants who are unable to complete clinical outcome assessments questionnaires are eligible."}
  • {"criterion_text":"-History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures or completion."}
  • {"criterion_text":"-Participant with symptoms and/or signs of systemic infection requiring parental oral antibiotics within 7 days prior to the first dose of study treatment."}
  • {"criterion_text":"-Prior history of severe or life-threatening events from any immune-mediated therapy."}
  • {"criterion_text":"-Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment (see Protocol section 5.2 for additional details)."}
  • {"criterion_text":"-Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (eg, non-live or nonreplicating agent) and live viral non-replicating vaccines (eg,Jynneos for mpox infection) within 3 days prior to first dose of study treatment."}
  • {"criterion_text":"-Receiving another anticancer therapy for a malignancy other than SCLC. Adjuvant hormonal therapy for resected breast cancer is permitted."}
  • {"criterion_text":"-History of other malignancy within the past 2 years, with the following exceptions (see Protocol 5.2 for exceptions)"}
  • {"criterion_text":"-Active or prior documented autoimmune or inflammatory disorders"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Progression free survival (BICR assessed)","definition_or_measurement_approach":"Assessed by BICR (blinded independent central review)."}

Secondary endpoints

  • {"endpoint_text":"-PFS","definition_or_measurement_approach":"As specified in secondary objectives: investigator assessment per RECIST 1.1 (and BICR for certain analyses as described)."}
  • {"endpoint_text":"-OR, DC, DOR","definition_or_measurement_approach":"Objective response (OR), disease control (DC) and duration of response (DOR) assessed by BICR and investigator per RECIST 1.1. DOR defined as time from first documentation of OR to first documentation of progression or death."}
  • {"endpoint_text":"-PFS rate at 6 months, 1 year, and 2 years from randomization OS rate at 6 months, 1 year, 2 years, and 3 years from randomization TTP","definition_or_measurement_approach":"PFS rates and OS rates reported at specified timepoints; PFS/TTP assessments based on BICR and investigator assessment per RECIST 1.1."}
  • {"endpoint_text":"-Incidence of treatment-emergent adverse events","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Serum concentrations of tarlatamab.","definition_or_measurement_approach":"Pharmacokinetic (PK) sampling to measure serum tarlatamab concentrations."}
  • {"endpoint_text":"-Incidence of anti-tarlatamab antibody formation.","definition_or_measurement_approach":"Assessment of immunogenicity by measuring anti-tarlatamab antibodies."}

Recruitment

Planned Sample Size
202
Recruitment Window Months
45
Consent Approach
Informed consent obtained from each participant prior to any study-specific procedures. Participants must be ≥18 years or the legal age in their country. Subject information and ICF materials (L1_SIS and ICF and related documents) are provided; multiple language versions and country-specific ICFs are available for participating countries.

Geography

Total Number Of Sites
59
Total Number Of Participants
129

Spain

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
192
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Noemi Reguart Aransay
Principal Investigator Email
nreguart@clinic.cat
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Oncologia
Principal Investigator Name
Oscar Jose Juan Vidal
Principal Investigator Email
Juan_osc@gva.es
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
Juan_osc@gva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Maria Vanesa Gutierrez Calderon
Principal Investigator Email
vgutierrezcald@gmail.com
Contact Person Name
Maria Vanesa Gutierrez Calderon
Contact Person Email
vgutierrezcald@gmail.com
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 Simoes Da Rocha
Principal Investigator Email
pedrorocha@vhio.net
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
Principal Investigator Name
Maria Eugenia Olmedo Garcia
Principal Investigator Email
mariaeugenia.olmedo@salud.madrid.org
Contact Person Name
Maria Eugenia Olmedo Garcia
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncologia
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat

France

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
216
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Centre Leon Berard
Department Name
Medical Oncology Department
Principal Investigator Name
Maurice Perol
Principal Investigator Email
maurice.perol@lyon.unicancer.fr
Contact Person Name
Maurice Perol
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pneumology Department
Principal Investigator Name
Jean Bernard Auliac
Principal Investigator Email
jean-bernard.auliac@chicreteil.fr
Contact Person Name
Jean Bernard Auliac
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Pneumology Department
Principal Investigator Name
Florian Guisier
Principal Investigator Email
florian.guisier@chu-rouen.fr
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
HIA Sainte Anne
Department Name
Pneumology Department
Principal Investigator Name
Olivier Bylicki
Principal Investigator Email
olivier.bylicki@intradef.gouv.fr
Contact Person Name
Olivier Bylicki
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology Department
Principal Investigator Name
Julien Mazieres
Principal Investigator Email
Mazieres.j@chu-toulouse.fr
Contact Person Name
Julien Mazieres
Contact Person Email
Mazieres.j@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Thoracic and Digestive Medical Oncology Department
Principal Investigator Name
Elvire Pons-Tostivint
Principal Investigator Email
elvire.pons@chu-nantes.fr
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Institut Curie
Department Name
Thoracic Oncology Department
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
Centre Hospitalier Regional De Marseille
Department Name
Multidisciplinary Oncology and Therapeutic Innovation Department
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

Denmark

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
197
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Region Midtjylland
Department Name
Kraeftafdelingen
Principal Investigator Name
Trine Heide Oellegaard
Principal Investigator Email
trine.oellegaard@auh.rm.dk
Contact Person Name
Trine Heide Oellegaard
Contact Person Email
trine.oellegaard@auh.rm.dk
Site Name
Rigshospitalet
Department Name
Onkologisk afdeling
Principal Investigator Name
Seppo Langer
Principal Investigator Email
Seppo.Langer@regionh.dk
Contact Person Name
Seppo Langer
Contact Person Email
Seppo.Langer@regionh.dk

Portugal

Earliest CTIS Part Ii Submission Date
27-05-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
286
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
João Moreira Pinto
Principal Investigator Email
joao.pmoreira.pinto@hospitaldaluz.pt
Contact Person Name
João Moreira Pinto
Site Name
Hospital Cuf Tejo S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
Telma Sequeira
Principal Investigator Email
telma.sequeira@jmellosaude.pt
Contact Person Name
Telma Sequeira
Contact Person Email
telma.sequeira@jmellosaude.pt
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Servico de Oncologia
Principal Investigator Name
Fernanda Estevinho
Principal Investigator Email
fernanda.estevinho@ulsm.min-saude.pt
Contact Person Name
Fernanda Estevinho

Belgium

Earliest CTIS Part Ii Submission Date
11-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
210
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumonology
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
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pneumonology
Principal Investigator Name
Sebahat Ocak
Principal Investigator Email
sebahat.ocak@chuuclnamur.uclouvain.be
Contact Person Name
Sebahat Ocak
Site Name
UZ Leuven
Department Name
Pneumonology
Principal Investigator Name
Els Wauters
Principal Investigator Email
els.wauters@uzleuven.be
Contact Person Name
Els Wauters
Contact Person Email
els.wauters@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Pneumonology
Principal Investigator Name
Astrid Paulus
Principal Investigator Email
apaulus@chuliege.be
Contact Person Name
Astrid Paulus
Contact Person Email
apaulus@chuliege.be
Site Name
Jessa Ziekenhuis
Department Name
Pneumonology
Principal Investigator Name
Kristof Cuppens
Principal Investigator Email
Kristof.Cuppens@jessazh.be
Contact Person Name
Kristof Cuppens
Contact Person Email
Kristof.Cuppens@jessazh.be

Poland

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
200
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
Oncology
Principal Investigator Name
Mateusz Polaczek
Principal Investigator Email
bk3@igichp.edu.pl
Contact Person Name
Mateusz Polaczek
Contact Person Email
bk3@igichp.edu.pl
Site Name
Centrum Pulmonologii I Torakochirurgii W Bystrej
Department Name
Oncology
Principal Investigator Name
Beata Kania-Zembaczyńska
Principal Investigator Email
bkania@szpitalbystra.pl
Contact Person Name
Beata Kania-Zembaczyńska
Contact Person Email
bkania@szpitalbystra.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology
Principal Investigator Name
Rafal Dziadziuszko
Principal Investigator Email
obkwf@uck.gda.pl
Contact Person Name
Rafal Dziadziuszko
Contact Person Email
obkwf@uck.gda.pl

Italy

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
214
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Jessica Menis
Principal Investigator Email
jessica.menis@aovr.veneto.it
Contact Person Name
Jessica Menis
Contact Person Email
jessica.menis@aovr.veneto.it
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Oncologia Medica
Principal Investigator Name
Chiara Matilde Catania
Principal Investigator Email
chiara.catania@gavazzeni.it
Contact Person Name
Chiara Matilde Catania
Contact Person Email
chiara.catania@gavazzeni.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Medica
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
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica
Principal Investigator Name
Vito Longo
Principal Investigator Email
v.longo@oncologico.bari.it
Contact Person Name
Vito Longo
Contact Person Email
v.longo@oncologico.bari.it
Site Name
Azienda Ospedaliera S Giovanni Addolorata
Department Name
Oncologia Medica
Principal Investigator Name
Antonio Luigini
Principal Investigator Email
alugini@hsangiovanni.roma.it
Contact Person Name
Antonio Luigini
Contact Person Email
alugini@hsangiovanni.roma.it

Austria

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
214
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical University Of Graz
Department Name
Universitätsklinik ür Innere Medizin, Klinische Abteilung für Onkologie
Principal Investigator Name
Philipp Jost
Principal Investigator Email
philipp.jost@medunigraz.at
Contact Person Name
Philipp Jost
Contact Person Email
philipp.jost@medunigraz.at
Site Name
Universitaetsklinikum Krems
Department Name
Klinische Abteilung für Pneumologie
Principal Investigator Name
Sabin Handzhiev
Principal Investigator Email
Sabin.Handzhiev@krems.lknoe.at
Contact Person Name
Sabin Handzhiev
Contact Person Email
Sabin.Handzhiev@krems.lknoe.at

Romania

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
216
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Medical Oncology
Principal Investigator Name
Dana Clement
Principal Investigator Email
secretariat@iroiasi.ro
Contact Person Name
Dana Clement
Contact Person Email
secretariat@iroiasi.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Principal Investigator Name
Tudor-Eliade Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
office@iocn.ro

Hungary

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
214
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Matrai Gyogyintezet
Department Name
III Pulmonologia
Principal Investigator Name
Albert Istvan
Principal Investigator Email
albert.magy@gmail.com
Contact Person Name
Albert Istvan
Contact Person Email
albert.magy@gmail.com
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
I Pulmonologiai Osztaly
Principal Investigator Name
Moldvay Judit
Principal Investigator Email
drmoldvay@hotmail.com
Contact Person Name
Moldvay Judit
Contact Person Email
drmoldvay@hotmail.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onko-pulmonologiai es Jarobetegellato Centrum
Principal Investigator Name
Galffy Gabriella
Principal Investigator Email
gabrielladrgalffy@gmail.com
Contact Person Name
Galffy Gabriella
Contact Person Email
gabrielladrgalffy@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
215
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Diseases
Principal Investigator Name
Anne-Marie Dingemans
Principal Investigator Email
a.dingemans@erasmusmc.nl
Contact Person Name
Anne-Marie Dingemans
Contact Person Email
a.dingemans@erasmusmc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Lung Diseases
Principal Investigator Name
Lizza Hendriks
Principal Investigator Email
lizza.hendriks@mumc.nl
Contact Person Name
Lizza Hendriks
Contact Person Email
lizza.hendriks@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Pulmonary Diseases
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

Germany

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
196
Number Of Sites
10
Number Of Participants
20

Sites

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
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Martin Wermke
Principal Investigator Email
Martin.Wermke@ukdd.de
Contact Person Name
Martin Wermke
Contact Person Email
Martin.Wermke@ukdd.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinaeres Studienzentrum (ISZ) mit ECTU
Principal Investigator Name
Horst-Dieter Hummel
Principal Investigator Email
isz_koordination@ukw.de
Contact Person Name
Horst-Dieter Hummel
Contact Person Email
isz_koordination@ukw.de
Site Name
Krankenhaus Nordwest GmbH
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
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik fuer Innere Medizin II Haematologie und Onkologie
Principal Investigator Name
Matthias Ritgen
Principal Investigator Email
matthias.ritgen@uksh.de
Contact Person Name
Matthias Ritgen
Contact Person Email
matthias.ritgen@uksh.de
Site Name
LungenClinic Grosshansdorf GmbH
Principal Investigator Name
Martin Reck
Principal Investigator Email
M.Reck@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
M.Reck@lungenclinic.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
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Lungenklinik/ Lungenkrebszentrum Koeln- Merheim
Principal Investigator Name
Eva-Lotte Buchmeier
Principal Investigator Email
buchmeiere@kliniken-koeln.de
Contact Person Name
Eva-Lotte Buchmeier
Contact Person Email
buchmeiere@kliniken-koeln.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik fur Innere Medizin IV
Principal Investigator Name
Stefan Hammerschmidt
Principal Investigator Email
S.Hammerschmidt@skc.de
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
S.Hammerschmidt@skc.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Medizinische Klinik III - Pulmologie
Principal Investigator Name
Sabine Bohnet
Principal Investigator Email
Sabine.Bohnet@uksh.de
Contact Person Name
Sabine Bohnet
Contact Person Email
Sabine.Bohnet@uksh.de

Greece

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
270
Number Of Sites
4
Number Of Participants
11

Sites

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
Athens Medical Center S.A.
Department Name
4th Department of Medical Oncology
Principal Investigator Name
Ippokratis Korantzis
Principal Investigator Email
ippokratis.korantzis@gmail.com
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Department of Oncology
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Alexandra Hospital
Department Name
Oncology Department, Department of Clinical Therapeutics
Principal Investigator Name
Michalis Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Imaging Vendor
Name
Suvoda LLC
Responsibilities
code 3
Name
Kayentis
Responsibilities
code 7

Third parties

  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment Supplier","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tarlatamab
Active Substance
TARLATAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Orphan Designation
Yes
Investigational Product Name
Durvalumab
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Carboplatin
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Etoposide
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Combination Treatment
Yes

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