Clinical trial • Phase III • Oncology

TARLATAMAB for Limited-stage small cell lung cancer

Phase III trial of TARLATAMAB for Limited-stage small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Limited-stage small cell lung cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
19-02-2024
First CTIS Authorization Date
03-06-2024

Trial design

Randomised, placebo matching tarlatamab administration (placebo arm; placebo administered to match tarlatamab iv infusion schedule).-controlled Phase III trial in Austria, Belgium, Bulgaria and others.

Randomised
Yes
Comparator
Placebo matching Tarlatamab administration (Placebo arm; placebo administered to match Tarlatamab IV infusion schedule).
Target Sample Size
255

Eligibility

Recruits 255 Vulnerable population selected. All participants must provide informed consent prior to any study-specific activities/procedures ("Subject has provided informed consent prior to initiation of any study specific activities/procedures."). Participants are adults (Age ≥ 18 years), so no assent for minors is described. Multiple subject information and informed consent forms and procedures are provided (country- and language-specific ICFs listed in the documents)..

Pregnancy Exclusion
Female subjects who are breastfeeding or to become pregnant who plan to breastfeed or while on study through 60 days after the last dose of study treatment.
Vulnerable Population
Vulnerable population selected. All participants must provide informed consent prior to any study-specific activities/procedures ("Subject has provided informed consent prior to initiation of any study specific activities/procedures."). Participants are adults (Age ≥ 18 years), so no assent for minors is described. Multiple subject information and informed consent forms and procedures are provided (country- and language-specific ICFs listed in the documents).

Inclusion criteria

  • {"criterion_text":"- Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n- Histologically or cytologically confirmed SCLC.\n- Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy\n- Has completed chemoradiotherapy without progression per RECIST 1.1. (ie, achieved CR, PR, or SD).\n- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n- Minimum life expectancy of 12 weeks.\n- Adequate organ function\n- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue."}

Exclusion criteria

  • {"criterion_text":"- Extensive-stage SCLC\n- Received sequential chemotherapy and thoracic radiotherapy during chemoradiation.\n- Prior therapy with any selective inhibitor of the DLL3 pathway.\n- Prior history of severe or life-threatening events from any immunemediated therapy.\n- Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.\n- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment\n- Major surgical procedures within 28 days prior to first dose of study treatment.\n- Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.\n- Treatment in an alternative investigational trial within 28 days prior to enrollment.\n- Female subjects of childbearing potential unwilling to use protocol specified method of contraception see protocol Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of study treatment.\n- Female subjects who are breastfeeding or to become pregnant who plan to breastfeed or while on study through 60 days after the last dose of study treatment.\n- Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.\n- Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.\n- Male subjects with a female partner of childbearing potential or a pregnant partner who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment\n- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.\n- Subject has known sensitivity to any of the products or components to be administered during dosing.\n- Subject likely to not be available to complete all protocol-required study visits or procedures\n- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n- Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n- History of arterial thrombosis within 6 months prior to first dose of study treatment.\n- History of other malignancy within the past 2 years. Refer to protocol section 5.2 for more details.\n- History of solid organ transplantation.\n- Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.\n- Presence of active Human immunodeficiency virus (HIV) or active hepatitis infection. Refer to protocol section 8.4.5.5 for more details.\n- Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.\n- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS (BICR)","definition_or_measurement_approach":"PFS assessed by blinded independent central review (BICR) per RECIST 1.1 (\"as assessed by progression free survival (PFS) based on blinded independent central review (BICR) per RECIST 1.1\")."}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) — comparison of tarlatamab versus placebo on prolonging overall survival (OS) (time-to-death from randomization)."}

Secondary endpoints

  • {"endpoint_text":"- PFS (investigator)","definition_or_measurement_approach":"PFS assessed by investigator per RECIST 1.1."}
  • {"endpoint_text":"- Complete response (CR) based on BICR and investigator assessment per RECIST 1.1. XX based on BICR and investigator assessment per RECIST 1.1. Duration of complete response.","definition_or_measurement_approach":"Complete response (CR) and duration of complete response assessed by BICR and investigator per RECIST 1.1."}
  • {"endpoint_text":"- \"PFS and OS rate at 6 months, 1 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 and OS rates at specified timepoints from randomization (6 months, 1 year, 2 years; OS also at 3 years). Time to progression (TTP) by BICR and investigator per RECIST 1.1."}
  • {"endpoint_text":"- Incidence of treatment-emergent adverse events after randomization","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events (TEAEs) post-randomization (safety/tolerability)."}
  • {"endpoint_text":"- Serum concentration of tarlatamab","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentrations of tarlatamab."}
  • {"endpoint_text":"- Incidence of anti-tarlatamab antibody formation","definition_or_measurement_approach":"Immunogenicity: incidence of anti-tarlatamab antibody formation."}

Recruitment

Planned Sample Size
255
Recruitment Window Months
66
Consent Approach
Informed consent is required from each participant prior to any study-specific activities/procedures ("Subject has provided informed consent prior to initiation of any study specific activities/procedures"). Participants are adults (≥18 years); no assent processes for minors are described. Subject information and informed consent forms and procedures are available in multiple languages and country-specific versions (document list includes ICFs and information materials in English, French, Dutch, Spanish, Greek, Polish, Portuguese, Bulgarian, Romanian, Italian and local-language versions as provided per country).

Geography

Total Number Of Sites
77
Total Number Of Participants
255

Austria

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
364
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine I
Contact Person Name
Thorsten Fuereder
Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine
Contact Person Name
Philipp Jakob Jost
Contact Person Email
philipp.jost@medunigraz.at

Belgium

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
357
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Longziekten
Contact Person Name
Dieter Stevens
Contact Person Email
dieter.stevens@uzgent.be
Site Name
Institut Jules Bordet
Department Name
Medical Oncology
Contact Person Name
Thierry Berghmans

Bulgaria

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
798
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department of Medical Oncology
Contact Person Name
Rossitza Krasteva Ruseva
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Department of Medical Oncology
Contact Person Name
Mariana Atanasova
Contact Person Email
drpandy@gmail.com
Site Name
Complex Oncological Center - Shumen EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Nikolay Nikolov
Contact Person Email
onconick@yahoo.com
Site Name
Military Medical Academy
Department Name
Clinic of Medical Oncology
Contact Person Name
Zhasmina Mihaylova Milanova
Contact Person Email
zhasmina.mihaylova@gmail.com
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
Department of Medical Oncology and Oncology Diseases in Pneumology
Contact Person Name
Ivan Tonev
Contact Person Email
dr.ivan.tonev@gmail.com
Site Name
UMHAT Sofiamed OOD
Department Name
Department of Medical Oncology
Contact Person Name
Velko Minchev
Contact Person Email
v_minchev@abv.bg
Site Name
MBAL Serdika Ltd.
Department Name
Second Department of Medical Oncology
Contact Person Name
Krassimir Koynov
Contact Person Email
kdkoynov@yahoo.co.uk

Sweden

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
353
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Vaesterbotten
Department Name
Cancercentrum
Contact Person Name
Mikael Johansson
Contact Person Email
mikael.b.johansson@umu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology
Contact Person Name
Tomas Krantz
Contact Person Email
tomas.krantz@vgregion.se

Italy

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
711
Number Of Sites
9
Number Of Participants
28

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unita Operativa Complessa Oncologia Medica
Contact Person Name
Emilio Bria
Site Name
Ospedale S G Moscati
Department Name
Struttura Complessa Oncologia Medica
Contact Person Name
Salvatore Pisconti
Contact Person Email
salvatorepisconti@hotmail.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Unità Operativa di Oncologia Medica
Contact Person Name
Francesca Zanelli
Contact Person Email
francesca.zanelli@ausl.re.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SS Tumori del polmone e della pleura
Contact Person Name
Brigida Stanzione
Contact Person Email
brigida.stanzione@cro.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione Clinica Oncologia Toracica
Contact Person Name
Ester Del Signore
Contact Person Email
ester.delsignore@ieo.it
Site Name
Humanitas Research Hospital
Department Name
Oncologia Medica ed Ematologia
Contact Person Name
Giovanna Finocchiaro
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia
Contact Person Name
Francesco Passiglia
Contact Person Email
francesco.passiglia@unito.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oncologia Medica
Contact Person Name
Giulio Metro
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Unità Operativa di Pneumologia
Contact Person Name
Iacopo Petrini
Contact Person Email
iacopo.petrini@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
739
Number Of Sites
17
Number Of Participants
25

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncologia
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncologia
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazares@hotmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Oncologia
Contact Person Name
Luis Leon Mateos
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia
Contact Person Name
Pedro Filipe Simões Da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncologia
Contact Person Name
Maria Vanesa Gutierrez Calderon
Contact Person Email
vanesa_gutierrez78@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Oncologia Medica
Contact Person Name
Marta Domenech Viñolas
Contact Person Email
mdomenech@iconcologia.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Servicio de Oncologia
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Oncologia Medica
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital Del Mar
Department Name
Servicio de Oncologia Medica
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
EArriola@parcdesalutmar.cat
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Servicio de Oncologia
Contact Person Name
Miguel Fernandez de Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Oncologia Medica
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Servicio de Oncologia
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Servicio de Oncologia
Contact Person Name
Miguel Fernandez de Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Servicio de Oncologia
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org

France

Earliest CTIS Part Ii Submission Date
24-05-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
685
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Pneumologie et Oncologie Thoracique
Contact Person Name
Simon Baldacci
Contact Person Email
drs.promotion@chru-lille.fr
Site Name
Les Hopitaux Nord-Ouest
Department Name
Service de Pneumologie et Cancérologie Thoracique
Contact Person Name
Lionel Falchero
Contact Person Email
lfalchero@ch-villefranche.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Pneumologie
Contact Person Name
Jacques Boutros
Contact Person Email
boutros.j@chu-nice.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'Oncologie Multidisciplinaire et Innovation Thérapeutiques
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Oncologie Thoracique
Contact Person Name
Gérard Zalcman
Contact Person Email
gerard.zalcman@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
730
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik fuer Haematologie und Onkologie
Contact Person Name
Tobias Overbeck
Contact Person Email
overbeck@med.uni-goettingen.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innnere Klinik - Tumorforschung
Contact Person Name
Martin Schuler
Contact Person Email
martin.schuler@uk-essen.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum (ISZ) mit ECTU, Haus A9 (A9.2.13.1)
Contact Person Name
Horst-Dieter Hummel
Contact Person Email
Hummel_H@ukw.de

Romania

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
698
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Spitalul Municipal Ploiesti
Department Name
Medical Oncology
Contact Person Name
Amedeia Lavinia Nita
Contact Person Email
spitalschuller@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Medical Oncology
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
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Oncomed S.R.L.
Department Name
Medical Oncology
Contact Person Name
Serban Mircea Negru
Contact Person Email
cabinet_oncomed@yahoo.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology
Contact Person Name
Aurelia Alexandru
Contact Person Email
secretariat@iob.ro
Site Name
Spital Clinic De Urgenta Prof Dr Agrippa Ionescu
Department Name
Medical Oncology
Contact Person Name
Cornelia Nitipir
Contact Person Email
secretariat.agrippa@dcti.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Elias University Emergency Hospital
Department Name
Medical Oncology
Contact Person Name
Cornelia Nitipir
Contact Person Email
contact@spitalul-elias.ro

Poland

Earliest CTIS Part Ii Submission Date
24-05-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
685
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oncology
Contact Person Name
Anna Łowczak
Contact Person Email
lowczakanna1@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Maciej Krzakowski
Contact Person Email
maciej.krzakowski@nio.gov.pl
Site Name
Centrum Pulmonologii I Torakochirurgii W Bystrej
Department Name
Oncology
Contact Person Name
Beata Kania-Zembaczyńska
Contact Person Email
bzembaczynska@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Oncology
Contact Person Name
Robert Mróz
Contact Person Email
robmmroz@gamil.com
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oncology
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology
Contact Person Name
Anna Kowalczyk
Contact Person Email
obkwf@uck.gda.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oncology
Contact Person Name
Tomasz Jankowski
Contact Person Email
tjankowski.onkolog@wp.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oncology
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl

Portugal

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
692
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Hospital CUF Porto S.A.
Department Name
Serviço de Oncologia
Contact Person Name
Venceslau Hespanhol
Contact Person Email
venceslau.hespanhol@cuf.pt
Site Name
Hospital Da Luz S.A.
Department Name
Serviço de Oncologia
Contact Person Name
João Moreira Pinto
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Oncologia Médica
Contact Person Name
Daniela Marques

Greece

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
804
Number Of Sites
11
Number Of Participants
17

Sites

Site Name
Athens Medical Center S.A. (Thessaloniki)
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.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
Metropolitan Hospital
Department Name
2nd Oncology Department
Contact Person Name
Epaminondas Samantas
Contact Person Email
epsam@otenet.gr
Site Name
St Savas Hospital
Department Name
2nd Medical Oncology Department
Contact Person Name
Anastasios Grivas
Contact Person Email
tssgrvs@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd Department of Internal Medicine and Laboratory
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
St. Luke's Hospital S.A. (Thessaloniki)
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Metropolitan General Hospital (Cholargos)
Department Name
5th Oncology Clinic
Contact Person Name
Theofanis Floros
Contact Person Email
Fanis_fl@yahoo.gr
Site Name
St. Luke's Hospital S.A. (Thessaloniki duplicate entry)
Department Name
Oncology Department
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com
Site Name
Athens Medical Center S.A. (duplicate entry)
Department Name
4th Department of Medical Oncology
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Clinic, Oncology Department
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department and Clinical Trials Unit
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Name
IQVIA Rds Inc.
Responsibilities
Patient recruitment

Third parties

  • {"country":"France","full_name":"Kayentis","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Pre-screenning","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"Imaging vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tarlatamab
Active Substance
TARLATAMAB
Modality
Bispecific antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
Placebo for Tarlatamab (AMG-757)
Modality
Other
Routes Of Administration
Intravenous
Route
Intravenous

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