Clinical trial • Phase III • Oncology

MK-1084 for Non-small cell lung cancer (non-squamous) | KRAS G12C-mutant non-small cell lung cancer

Phase III trial of MK-1084 for Non-small cell lung cancer (non-squamous) | KRAS G12C-mutant non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (non-squamous) | KRAS G12C-mutant non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-08-2025
First CTIS Authorization Date
27-11-2025

Trial design

Randomised, open-label, mk-3475a (pembrolizumab) in combination with pemetrexed plus platinum chemotherapy (carboplatin or cisplatin). pemetrexed listed with a dosing reference of 500 mg/m2 (product metadata). cisplatin listed with a dosing reference of 75 mg/m2 (product metadata). carboplatin dosing not clearly specified in published metadata.-controlled Phase III trial in Austria, France, Hungary and others.

Randomised
Yes
Open Label
Yes
Comparator
MK-3475A (pembrolizumab) in combination with pemetrexed plus platinum chemotherapy (carboplatin or cisplatin). Pemetrexed listed with a dosing reference of 500 mg/m2 (product metadata). Cisplatin listed with a dosing reference of 75 mg/m2 (product metadata). Carboplatin dosing not clearly specified in published metadata.
Biomarker Stratified
True, PD-L1 Tumor Proportion Score (TPS) ≥1% (primary subgroup); KRAS G12C mutation (eligibility biomarker)
Target Sample Size
510

Eligibility

Recruits 510 Vulnerable population not selected. Trial enrols adult patients; informed consent obtained from participants (no assent or paediatric consent procedures described). Country-specific participant information and consent documents and optional addenda are provided per country..

Vulnerable Population
Vulnerable population not selected. Trial enrols adult patients; informed consent obtained from participants (no assent or paediatric consent procedures described). Country-specific participant information and consent documents and optional addenda are provided per country.

Inclusion criteria

  • {"criterion_text":"- Has nonsquamous non—small cell lung cancer (NSCLC) (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c"}
  • {"criterion_text":"- If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)"}

Exclusion criteria

  • {"criterion_text":"- Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements"}
  • {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
  • {"criterion_text":"- Has active infection requiring systemic therapy except those specified by protocol"}
  • {"criterion_text":"- Has history of stem cell/solid organ transplant"}
  • {"criterion_text":"- Has not adequately recovered from major surgery or has ongoing surgical complications"}
  • {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"}
  • {"criterion_text":"- Has a gastrointestinal disorder affecting absorption"}
  • {"criterion_text":"- Is HIV positive and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
  • {"criterion_text":"- Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC"}
  • {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
  • {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%","definition_or_measurement_approach":"PFS per RECIST 1.1 by blinded independent central review (BICR)"}

Secondary endpoints

  • {"endpoint_text":"- PFS in All Participants","definition_or_measurement_approach":"PFS per RECIST 1.1 by BICR"}
  • {"endpoint_text":"- Overall Survival (OS) in Participants with PD-L1 TPS ≥1%","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS in All Participants","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall Response Rate (ORR) in All Participants","definition_or_measurement_approach":"ORR per RECIST 1.1 by BICR"}
  • {"endpoint_text":"- ORR in Participants with PD-L1 TPS ≥1%","definition_or_measurement_approach":"ORR per RECIST 1.1 by BICR"}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 by BICR"}
  • {"endpoint_text":"- Number of Participants Who Experienced One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants with ≥1 adverse event (safety/tolerability endpoint)"}
  • {"endpoint_text":"- Number of Participants Who Discontinued Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinued study treatment due to an AE"}
  • {"endpoint_text":"- Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 (items 29, 30)"}
  • {"endpoint_text":"- Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 item 8"}
  • {"endpoint_text":"- Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13)","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-LC13 item 31"}
  • {"endpoint_text":"- Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-LC13 item 40"}
  • {"endpoint_text":"- Time to Deterioration (TTD) in GHS/QoL (Items 29, 30) on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to deterioration based on EORTC QLQ-C30 (items 29, 30)"}
  • {"endpoint_text":"- TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30","definition_or_measurement_approach":"Time to deterioration based on EORTC QLQ-C30 item 8"}
  • {"endpoint_text":"- TTD in Cough Score (Item 31) on the EORTC QLQ-LC13","definition_or_measurement_approach":"Time to deterioration based on EORTC QLQ-LC13 item 31"}
  • {"endpoint_text":"- TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13","definition_or_measurement_approach":"Time to deterioration based on EORTC QLQ-LC13 item 40"}

Recruitment

Planned Sample Size
510
Recruitment Window Months
80
Consent Approach
Informed consent obtained from adult participants. Multiple country-specific participant information and consent forms and translations are provided (documents include country-language ICFs and recruitment arrangements for e.g., English, French, German, Hungarian, Spanish, Italian, Polish, Greek, Romanian, Dutch, etc.). Optional consent modules are available (e.g., limited screening consent, pregnancy follow-up, genetic consent, addendum for disease progression). No paediatric assent or minor consent procedures are described.

Geography

Total Number Of Sites
57
Total Number Of Participants
218

Austria

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
27
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Abteilung für Innere Medizin und Pulmologie
Principal Investigator Name
Barbara Mittergradnegger
Principal Investigator Email
barbara.mittergradnegger@kabeg.at
Contact Person Name
Barbara Mittergradnegger
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Abteilung für Innere Medizin und Pneumologie
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für Pulmonologie
Principal Investigator Name
Christoph Wohlkönig
Principal Investigator Email
christoph.wohlkoenig@uniklinikum.kages.at
Contact Person Name
Christoph Wohlkönig

France

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
38
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ​
Department Name
Service de Pneumologie
Principal Investigator Name
Gautier TREFFEL
Principal Investigator Email
g.treffel@chru-nancy.fr
Contact Person Name
Gautier TREFFEL
Contact Person Email
g.treffel@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Oncologie Thoracique
Principal Investigator Name
Elisabeth FABRE
Principal Investigator Email
elizabeth.fabre@aphp.fr
Contact Person Name
Elisabeth FABRE
Contact Person Email
elizabeth.fabre@aphp.fr
Site Name
Hôpital Européen ​Marseille​
Department Name
Service de Pneumologie
Principal Investigator Name
Jacques LETREUT
Principal Investigator Email
J.letreut@hopital-europeen.fr
Contact Person Name
Jacques LETREUT
Contact Person Email
J.letreut@hopital-europeen.fr
Site Name
Groupe hospitalier Paris Saint Joseph​
Department Name
Service de Pneumo-oncologie et d'Allergologie
Principal Investigator Name
Charles NALTET
Principal Investigator Email
cnaltet@ghpsj.fr
Contact Person Name
Charles NALTET
Contact Person Email
cnaltet@ghpsj.fr
Site Name
Clinique de l'Europe
Department Name
Service de Pneumologie
Principal Investigator Name
Charles DAYEN
Principal Investigator Email
c.dayen@ch-stquentin.fr
Contact Person Name
Charles DAYEN
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre Hospitalier Metropole Savoie
Department Name
Service de Pneumologie
Principal Investigator Name
Julian PINSOLLE
Principal Investigator Email
julian.pinsolle@ch-metropole-savoie.fr
Contact Person Name
Julian PINSOLLE
Site Name
CHU Caen​
Department Name
Service de Pneumologie et d'Oncologie Thoracique
Principal Investigator Name
Simon DESHAYES
Principal Investigator Email
deshayes-si@chu-caen.fr
Contact Person Name
Simon DESHAYES
Contact Person Email
deshayes-si@chu-caen.fr

Hungary

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
49
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Semmelweis University
Department Name
Pulmonológiai Klinika
Principal Investigator Name
Veronika Müller
Principal Investigator Email
muller.veronika@med.semmelweis-univ.hu
Contact Person Name
Veronika Müller
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Principal Investigator Name
Gabriella Gálffy
Principal Investigator Email
galffy.gabriella@rpckorhaz.hu
Contact Person Name
Gabriella Gálffy
Contact Person Email
galffy.gabriella@rpckorhaz.hu
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
I. Pulmonológiai Osztály
Principal Investigator Name
Judit Moldvay
Principal Investigator Email
drmoldvay@hotmail.com
Contact Person Name
Judit Moldvay
Contact Person Email
drmoldvay@hotmail.com

Spain

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
27
Number Of Sites
8
Number Of Participants
38

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Maria Rosario Garcia Campelo
Principal Investigator Email
maria.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Universitario Virgen De Valme
Department Name
Medical Oncology
Principal Investigator Name
Adrián Sánchez Vegas
Principal Investigator Email
adrianvegas89@gmail.com
Contact Person Name
Adrián Sánchez Vegas
Contact Person Email
adrianvegas89@gmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
Paula Espinosa Olarte
Principal Investigator Email
paula.espinosa.olarte@gmail.com
Contact Person Name
Paula Espinosa Olarte
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Pilar Garrido López
Principal Investigator Email
pgarrido@salud.madrid.org
Contact Person Name
Pilar Garrido López
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Laura Mezquita Pérez
Principal Investigator Email
lmezquita@clinic.cat
Contact Person Name
Laura Mezquita Pérez
Contact Person Email
lmezquita@clinic.cat
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Principal Investigator Name
Enric Carcereny Costa
Principal Investigator Email
ecarcereny@iconcologia.net
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda (duplicate listing may be administrative)

Poland

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
30-11-2025
Processing Time Days
30
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Principal Investigator Name
Kamil Kuć
Principal Investigator Email
kkuc@wszp.pl
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddział w Gliwicach, Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Barbara Ziółkowska
Principal Investigator Email
cwbk@gliwice.nio.gov.pl
Contact Person Name
Barbara Ziółkowska
Contact Person Email
cwbk@gliwice.nio.gov.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Principal Investigator Name
Jarosław Kołb-Sielecki
Principal Investigator Email
sekretariat@wmccp.pl
Contact Person Name
Jarosław Kołb-Sielecki
Contact Person Email
sekretariat@wmccp.pl

Germany

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
30-12-2025
Processing Time Days
49
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik für Hämatologie, Onkologie, Stuttgart Cancer Center (SCC)
Principal Investigator Name
Markus Knott
Principal Investigator Email
scc-studienzentrale@klinikum-stuttgart.de
Contact Person Name
Markus Knott
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik III, Onkologie/Hämatologie
Principal Investigator Name
Jürgen Alt
Principal Investigator Email
juergen.alt@unimedizin-mainz.de
Contact Person Name
Jürgen Alt
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Oliver Schmalz
Principal Investigator Email
Oliver.Schmalz@helios-gesundheit.de
Contact Person Name
Oliver Schmalz
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III (Onkologie, Hämatologie)
Principal Investigator Name
Tessa Hattenhauer
Principal Investigator Email
Tessa.Hattenhauer@ukbonn.de
Contact Person Name
Tessa Hattenhauer
Contact Person Email
Tessa.Hattenhauer@ukbonn.de

Italy

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
98
Number Of Sites
13
Number Of Participants
44

Sites

Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncologia Medica
Principal Investigator Name
Sara Pilotto
Principal Investigator Email
Sara.pilotto@univr.it
Contact Person Name
Sara Pilotto
Contact Person Email
Sara.pilotto@univr.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncologia
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Anna Cecilia Bettini
Principal Investigator Email
abettini@asst-pg23.it
Contact Person Name
Anna Cecilia Bettini
Contact Person Email
abettini@asst-pg23.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O Oncologia Medica ed Ematologia
Principal Investigator Name
Giovanna Finocchiaro
Contact Person Name
Giovanna Finocchiaro
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Marianna Macerelli
Principal Investigator Email
marianna.macerelli@asufc.sanita.fvg.it
Contact Person Name
Marianna Macerelli
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SSD Oncologia Toracica
Principal Investigator Name
Alberto Verlicchi
Principal Investigator Email
alberto.verlicchi@irst.emr.it
Contact Person Name
Alberto Verlicchi
Contact Person Email
alberto.verlicchi@irst.emr.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Oncologia Falk
Principal Investigator Name
Diego Signorelli
Principal Investigator Email
diego.signorelli@ospedaleniguarda.it
Contact Person Name
Diego Signorelli
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SODc Oncologia Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
SSD Oncologia
Principal Investigator Name
Federica Bertolini
Principal Investigator Email
bertolini.federica@aou.mo.it
Contact Person Name
Federica Bertolini
Contact Person Email
bertolini.federica@aou.mo.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
U.O.C Oncologia ed Ematologia
Principal Investigator Name
Ferdinando Riccardi
Principal Investigator Email
ferdinando.riccardi@aocardarelli.it
Contact Person Name
Ferdinando Riccardi
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
SOC Oncologia
Principal Investigator Name
Vito Barbieri
Principal Investigator Email
vitobarbieri@yahoo.it
Contact Person Name
Vito Barbieri
Contact Person Email
vitobarbieri@yahoo.it
Site Name
Ospedale S G Moscati
Department Name
U.O.C Oncologia Medica
Principal Investigator Name
Salvatore Pisconti
Principal Investigator Email
salvatore.pisconti@asl.taranto.it
Contact Person Name
Salvatore Pisconti
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC Oncologia Medica
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it

Netherlands

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
7
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Stichting Elisabeth-TweeSteden Ziekenhuis
Department Name
Pulmonology department
Principal Investigator Name
Brian De Bruijn
Principal Investigator Email
Secretariaat-Longartsen@etz.nl
Contact Person Name
Brian De Bruijn
Contact Person Email
Secretariaat-Longartsen@etz.nl
Site Name
Amphia Hospital
Department Name
Pulmonology department
Principal Investigator Name
Lysanne Lievense
Principal Investigator Email
researchlongoncologie@amphia.nl
Contact Person Name
Lysanne Lievense

Belgium

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
65
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Pneumology
Principal Investigator Name
Maarten Criel
Principal Investigator Email
maarten.criel@zol.be
Contact Person Name
Maarten Criel
Contact Person Email
maarten.criel@zol.be

Greece

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
147
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Laiko General Hospital Of Athens
Department Name
First Department of Internal Medicine Medical School, NKUA
Principal Investigator Name
Dimitrios Ziogas
Principal Investigator Email
ziogasdc@gmail.com
Contact Person Name
Dimitrios Ziogas
Contact Person Email
ziogasdc@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
D Oncology Clinical Trial Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
General Hospital Of Patras Agios Andreas
Department Name
Oncology Unit
Principal Investigator Name
Athina Christopoulou
Principal Investigator Email
athinachristo@hotmail.com
Contact Person Name
Athina Christopoulou
Contact Person Email
athinachristo@hotmail.com
Site Name
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A
Department Name
5th Oncology Department
Principal Investigator Name
Theofanis Floros
Principal Investigator Email
fanis_fl@yahoo.gr
Contact Person Name
Theofanis Floros
Contact Person Email
fanis_fl@yahoo.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
B’ Department of Medical Oncology, Aristotle University of Thessaloniki (AUTH)
Principal Investigator Name
Georgios Lazaridis
Principal Investigator Email
georlaz@yahoo.gr
Contact Person Name
Georgios Lazaridis
Contact Person Email
georlaz@yahoo.gr

Romania

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
99
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Michael Schenker
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie Medicala
Principal Investigator Name
Amedeia Nita
Principal Investigator Email
cab.oncologie@smploiesti.ro
Contact Person Name
Amedeia Nita
Contact Person Email
cab.oncologie@smploiesti.ro
Site Name
Onco Card S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Bogdan Carlan
Principal Investigator Email
office@medlife.ro
Contact Person Name
Bogdan Carlan
Contact Person Email
office@medlife.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Principal Investigator Name
Paul Kubelac
Principal Investigator Email
office@iocn.ro
Contact Person Name
Paul Kubelac
Contact Person Email
office@iocn.ro
Site Name
Delta Health Care S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Andreea Craciunescu
Principal Investigator Email
office.ponderas@reginamaria.ro
Contact Person Name
Andreea Craciunescu
Contact Person Email
office.ponderas@reginamaria.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
office.otopeni@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Spitalul Clinic Coltea
Department Name
Oncologie Medicala
Principal Investigator Name
Raluca Patru
Principal Investigator Email
secretariat@coltea.ro
Contact Person Name
Raluca Patru
Contact Person Email
secretariat@coltea.ro
Site Name
Mnt Healthcare Europe S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Bogdan Georgescu
Principal Investigator Email
office@neolife.ro
Contact Person Name
Bogdan Georgescu
Contact Person Email
office@neolife.ro

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
PPD Development LP
Responsibilities
sponsorDuties code 4 (role code provided in registry)
Name
Icon Public Limited Company
Responsibilities
sponsorDuties code 4 (role code provided in registry)
Name
Bioclinica Inc.
Responsibilities
Central Imaging
Name
Syneos Health Clinique Inc.
Responsibilities
sponsorDuties code 4 (role code provided in registry)

Third parties

  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
MK-1084
Active Substance
MK-1084
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=1 (authorised product record in registry metadata)
Investigational Product Name
MK-3475A
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
prodAuthStatus=1 (authorised product record in registry metadata)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.