Clinical trial • Phase III • Oncology

MRNA-4157 for Non-small cell lung cancer

Phase III trial of MRNA-4157 for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
mRNA | Monoclonal antibody

Key dates

Initial CTIS Submission Date
24-10-2023
First CTIS Authorization Date
22-03-2024

Trial design

Randomised, adjuvant placebo (saline solution for placebo to v940) plus pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion) versus v940 (mrna-4157) plus pembrolizumab (keytruda 25 mg/ml). doses and schedule not specified in the provided record.-controlled Phase III trial in Belgium, France, Estonia and others.

Randomised
Yes
Comparator
Adjuvant placebo (Saline solution for Placebo to v940) plus pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion) versus V940 (mRNA-4157) plus pembrolizumab (KEYTRUDA 25 mg/mL). Doses and schedule not specified in the provided record.
Target Sample Size
618

Eligibility

Recruits 618 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is handled using standard subject information and informed consent forms (numerous L1_ICF_Main consent documents are provided per country). Optional consent addenda (for limited screening, disease progression, genetic consent, pregnancy follow-up and other optional consents) are available. No assent or parental consent procedures for minors are described..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is handled using standard subject information and informed consent forms (numerous L1_ICF_Main consent documents are provided per country). Optional consent addenda (for limited screening, disease progression, genetic consent, pregnancy follow-up and other optional consents) are available. No assent or parental consent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Has undergone margin negative, completely resected non–small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n- Has no evidence of disease before randomization.\n- Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n- No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\n- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n- Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- Active infection requiring systemic therapy.\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.\n- Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n- Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n- Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease-Free Survival (DFS)","definition_or_measurement_approach":"To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS"}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS"}
  • {"endpoint_text":"- Distant Metastasis-Free Survival (DMFS)","definition_or_measurement_approach":"To evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab with respect to DMFS as assessed by the investigator."}
  • {"endpoint_text":"- Lung Cancer Specific Survival (LCSS)","definition_or_measurement_approach":"To evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab with respect to LCSS"}
  • {"endpoint_text":"- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-C30 Global Health Status/Quality of Life combined score (items 29 and 30)."}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-C30 Physical Functioning combined score (items 1–5)."}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-C30 Role Functioning combined score (items 6 and 7)."}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-C30 dyspnea item (item 8)."}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-LC24 coughing combined score (items 31 and 52)."}
  • {"endpoint_text":"- Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24","definition_or_measurement_approach":"Change from baseline measured using the EORTC QLQ-LC24 chest pain item (item 40)."}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events (AEs)."}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment because of an adverse event."}

Recruitment

Digital Remote Recruitment
True, documents reference digital/remote elements such as country-specific websites (e.g. Poland website document), voice scripts, Greenphire/ClinCard/ConneX travel logistical/payment materials and other electronic study support documents.
Planned Sample Size
618
Recruitment Window Months
140
Consent Approach
Informed consent is obtained using country-specific L1_ICF_Main consent forms (multiple L1_ICF_Main consent documents listed by country/language). Optional consent forms/addenda are available (limited screening consent, prescreening consent, genetic consent, pregnancy follow-up, disease progression addendum, optional Greenphire/ClinCard information). Consent materials are provided in multiple languages per country as per the document list. No assent/parental consent procedures for minors are described.

Methods

  • Posters (country- and language-specific K2_Recruitment Doc Poster files listed)
  • Patient brochures and adjuvant brochures (K2_Recruitment Doc Patient Brochure / Adjuvant Brochure files listed)
  • Patient visit guides (K2_Recruitment Doc Patient Visit Guide files listed)
  • Website recruitment (K2_Recruitment Doc Website_POL_PL listed)
  • Study cards / patient cards (K2_Recruitment Doc Study Card, Patient ID Card files listed)
  • Voice scripts for QLQ-C30 (K1 recruitment voice script referenced)
  • GP letters (L1_Patient GP Letter_IRL_EN listed)
  • Post-enrolment materials: patient thank you cards and visit schemes

Geography

Total Number Of Sites
80
Total Number Of Participants
465

Belgium

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
749
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
AZORG
Department Name
Pneumology Department
Contact Person Name
Kurt Tournoy
Contact Person Email
kurt.tournoy@azorg.be
Site Name
Antwerp University Hospital
Department Name
Longziekten
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
Vitaz
Department Name
Dienst longziekten
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pneumologie
Contact Person Name
Sebahat Ocak

France

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
766
Number Of Sites
9
Number Of Participants
45

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service des maladies respiratoires
Contact Person Name
Rémi VEILLON
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service de Pneumologie et d'Oncologie thoracique
Contact Person Name
Simon Deshayes
Contact Person Email
Deshayes-si@chu-caen.fr
Site Name
CHU Gabriel-Montpied
Department Name
Department Thoracic Oncology
Contact Person Name
Henri Janicot
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Service d'Oncologie multidisciplinaire et Innovations therapeutiques
Contact Person Name
Laurent Greillier
Contact Person Email
Laurent.greillier@ap-hm.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology Department
Contact Person Name
Celine Mascaux
Site Name
Institut De Cancerologie De L Ouest
Department Name
Département d'oncologie médicale
Contact Person Name
Frédéric Bigot
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Pneumologie - Unité d'oncologie thoracique
Contact Person Name
Marie Wislez
Contact Person Email
Marie.wislez@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Department Thoracic Oncology
Contact Person Name
Benoit Roch
Contact Person Email
B-roch@chu-montpellier.fr
Site Name
CHU Gabriel-Montpied (duplicate entry not expected)

Estonia

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
738
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Tartu University Hospital
Department Name
Haematology and Oncology Clinic
Contact Person Name
Jana Jaal
Contact Person Email
jana.jaal@kliinikum.ee
Site Name
North Estonia Medical Centre Foundation
Department Name
Chemotherapy Deprartment
Contact Person Name
Kersti Oselin

Spain

Earliest CTIS Part Ii Submission Date
08-11-2023
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
834
Number Of Sites
7
Number Of Participants
60

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente
Contact Person Email
david.vbaz@gmail.com
Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Contact Person Name
Belén Rubio
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Ernest Nadal
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncoloy
Contact Person Name
Alexandre Martínez
Contact Person Email
amartinezmarti@vhio.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology
Contact Person Name
Mariano Provencio
Site Name
Hospital Universitario Virgen De La Macarena (duplicate placeholder)

Greece

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
756
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Department of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
D Oncology department
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
727
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Ana Rodrigues
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Paula Alves
Contact Person Email
pmasantos@hotmail.com

Latvia

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
748
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Rigas Austrumu kliniska universitates slimnica SIA
Department Name
Latvian Oncology center
Contact Person Name
Alinta Hegmane
Contact Person Email
alinta.hegmane@aslimnica.lv

Germany

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
751
Number Of Sites
10
Number Of Participants
61

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Med II / Pneumologie
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Augusta-Kranken-Anstalt gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Robert Radkowski
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Department Name
Hamatologie Und Oncologie
Contact Person Name
Ruediger Liersch
Contact Person Email
geho@onkologie-muenster.de
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinikum Kempten, MVZ Pneumologie im ÄH
Contact Person Name
Christian Schumann
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
LungenClinic Grosshansdorf GmbH
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
Klinikum Esslingen GmbH
Department Name
Thoraxzentrum Südwest
Contact Person Name
Martin Faehling
Site Name
Asklepios Fachkliniken Muenchen Gauting
Department Name
Klinik für Thorakale Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
studien.gauting@asklepios.com
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Zentrum für klinische Studien
Contact Person Name
Dagmar Taeuscher
Contact Person Email
studienzentrum.wkg@srh.de
Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Pneumologie
Contact Person Name
Jens Kollmeier

Czechia

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
754
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicní oddělení
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologická klinika
Contact Person Name
Petra Zemanová
Contact Person Email
petra.zemanova@vfn.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicních nemocí a tuberkulózy
Contact Person Name
Juraj Kultan
Contact Person Email
Juraj.kultan@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Ondřej Bílek
Contact Person Email
bilek@mou.cz

Ireland

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
766
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Tallaght University Hospital
Department Name
Oncology Department
Contact Person Name
Sebastian Trainor
Contact Person Email
Sebastian.Trainor@tuh.ie

Italy

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
757
Number Of Sites
10
Number Of Participants
45

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Dipartimento di Oncologia
Contact Person Name
Francesco Cortiula
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
UOC Oncologia Medica
Contact Person Name
Hector Soto Parra
Contact Person Email
hsotoparra.ctu@gmail.com
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
SC Oncologia
Contact Person Name
Ida Colantonio
Contact Person Email
colantonio.i@ospedale.cuneo.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia Medica
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C Pneumologia Oncologica DH PNL ONC
Contact Person Name
Danilo Rocco
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
S.C.D.U. Oncologia
Contact Person Name
Gloria Borra
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Oncologia Falck
Contact Person Name
Salvatore Siena
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Giuseppe Lorusso
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica per la Patologia Toracica
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Dipartimento di Oncologia
Contact Person Name
Maria Francesca Currà

Slovakia

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
756
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Nemocnica BORY a.s.
Department Name
Klinická onkológia
Contact Person Name
Richard Hrubý
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Oddelenie pneumológie a ftizeológie
Contact Person Name
Michal Urda
Contact Person Email
murda@nspbb.sk
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Oddelenie klinickej onkológie
Contact Person Name
Jana Jankurová
Contact Person Email
jankurova@vou.sk
Site Name
University Hospital Bratislava
Department Name
Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB Oddelenie klinickej onkológie
Contact Person Name
Zuzana Svihelova Liskova
Contact Person Email
zuzana.svihelova@ru.unb.sk

Finland

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
750
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Turku University Hospital
Department Name
Pulmonary Medicine
Contact Person Name
Maria Silvoniemi
Contact Person Email
maria.silvoniemi@varha.fi
Site Name
Oulu University Hospital
Department Name
Oncology and Hematology
Contact Person Name
Jussi Koivunen
Contact Person Email
jussi.koivunen@pohde.fi
Site Name
Vaasa Central Hospital
Department Name
Clinical Oncology
Contact Person Name
Ravichandra Ravi
Contact Person Email
ravichandra.ravi@ovph.fi
Site Name
Tampere University Hospital
Department Name
Oncology
Contact Person Name
Jarkko Ahvonen
Contact Person Email
jarkko.ahvonen@pirha.fi

Poland

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
765
Number Of Sites
8
Number Of Participants
82

Sites

Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. Dr E. Pileckiej z pododdziałem Chemioterapii Dziennej
Contact Person Name
Iwona Zakrzewska
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jarosław Kołb-Sielecki
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.p
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika onkologii i Radioterapii
Contact Person Name
Anna Kowalczyk
Contact Person Email
akow@gumed.edu.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chirurgii Klatki Piersiowej i Chirurgii Onkologicznej
Contact Person Name
Piotr Kocoń
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@pib-nio.pl

Norway

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
761
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Helse Stavanger HF
Department Name
Lungeseksjonen
Contact Person Name
Madebo Tesfaye
Contact Person Email
tesfaye.madebo@sus.no
Site Name
Vestre Viken HF
Department Name
Department of Oncology, Surgical Department
Contact Person Name
Odd Terje Brustugun
Contact Person Email
otr@vestreviken.no
Site Name
Akershus University Hospital
Department Name
Avdeling for lungesykdommer
Contact Person Name
Neumann Kirill
Contact Person Email
kirill.neumann@ahus.no

Lithuania

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
761
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Pulmonology department
Contact Person Name
Marius Žemaitis
Site Name
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Department Name
Thoracic surgery and oncology department
Contact Person Name
Vaida Gedvilaite
Contact Person Email
vaida.gedvilaite@nvi.lt

Hungary

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
775
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Onkológiai Központ
Contact Person Name
Judit Kalincsák
Contact Person Email
judit.kalincsak@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológia Osztály
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
szalaizs@petz.gyor.hu
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Contact Person Name
Gabriella Galffy
Contact Person Email
galffy.gabriella@rpckorhaz.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Judit Kocsis
Contact Person Email
kocsisj@kmk.hu
Site Name
University Of Pecs
Department Name
Onkoterápiás Intézet
Contact Person Name
Árpád Boronkai
Contact Person Email
arpad.boronkai@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
733
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Steen Riisgaard de Blanck
Site Name
Odense University Hospital
Department Name
Onkologisk Afdeling R
Contact Person Name
Lotte Holm Land
Contact Person Email
ouh.ode.r.ctis@rsyd.dk

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Almac Clinical Technologies LLC
Responsibilities
code:3
Name
Medidata Solutions Inc.
Responsibilities
code:7
Name
Pharmaceutical Product Development LLC
Responsibilities
code:4
Name
Fortrea Inc.
Responsibilities
unblinded monitoring service
Name
PRA International
Responsibilities
Central imaging

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"unblinded monitoring service","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PRA International","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
mRNA-4157
Active Substance
MRNA-4157
Modality
mRNA
Routes Of Administration
DISPERSION FOR INJECTION
Route
Dispersion for injection
Authorisation Status
Investigational (no EU marketing authorisation listed)
Investigational Product Name
Saline solution for Placebo to v940 (mrna-4157)
Modality
Other
Authorisation Status
Placebo (not applicable)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION (solution for infusion)
Route
Solution for infusion
Authorisation Status
Authorised (EU marketing authorisation EU/1/15/1024/002)
Combination Treatment
Yes

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