Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer (resectable clinical Stage II–IIIB with N2 nodal involvement)

Phase III trial of SACITUZUMAB TIRUMOTECAN for Non-small cell lung cancer (resectable clinical Stage II–IIIB with N2 nodal involvement).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (resectable clinical Stage II–IIIB with N2 nodal involvement)
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody

Key dates

Initial CTIS Submission Date
23-01-2024
First CTIS Authorization Date
13-05-2024

Trial design

Randomised, open-label, pembrolizumab monotherapy (keytruda 25 mg/ml concentrate for solution for infusion) — comparator; investigational arm: mk-2870 (sacituzumab tirumotecan) given with pembrolizumab. doses/schedule not specified in ctis record.-controlled Phase III trial in Spain, Greece, Norway and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab monotherapy (KEYTRUDA 25 mg/mL concentrate for solution for infusion) — comparator; Investigational arm: MK-2870 (sacituzumab tirumotecan) given with pembrolizumab. Doses/schedule not specified in CTIS record.
Biomarker Stratified
True, PD-L1 and TROP2
Target Sample Size
536
Trial Duration For Participant
1620

Eligibility

Recruits 536 No vulnerable populations selected in CTIS; standard informed consent from adult participants is required. No assent or parental consent procedures for minors are specified in the CTIS entries..

Vulnerable Population
No vulnerable populations selected in CTIS; standard informed consent from adult participants is required. No assent or parental consent procedures for minors are specified in the CTIS entries.

Inclusion criteria

  • {"criterion_text":"- Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines."}
  • {"criterion_text":"- 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 at screening"}
  • {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention"}
  • {"criterion_text":"- Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy"}
  • {"criterion_text":"- Is able to undergo surgery based on opinion of investigator after consultation with surgeon"}
  • {"criterion_text":"- Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy"}
  • {"criterion_text":"- Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology"}
  • {"criterion_text":"- Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period"}
  • {"criterion_text":"- Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization"}
  • {"criterion_text":"- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible"}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}

Exclusion criteria

  • {"criterion_text":"- Has one of the following tumor locations/types: •\tNSCLC involving the superior sulcus •\tLarge cell neuro-endocrine cancer (LCNEC) •\tSarcomatoid tumor •\tDiagnosis of SCLC or, for mixed tumors, presence of small cell elements"}
  • {"criterion_text":"- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration"}
  • {"criterion_text":"- Has a 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"}
  • {"criterion_text":"- Has a known additional malignancy that is progressing or has required active treatment within the past 5"}
  • {"criterion_text":"- Has an active autoimmune disease that has required systemic treatment in the past 2 years"}
  • {"criterion_text":"- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease."}
  • {"criterion_text":"- Has an active infection requiring systemic therapy"}
  • {"criterion_text":"- Is an HIV-infected participant with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
  • {"criterion_text":"- Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection"}
  • {"criterion_text":"- Has a history of allogeneic tissue/solid organ transplant"}
  • {"criterion_text":"- Has not adequately recovered from major surgery or have ongoing surgical complications"}
  • {"criterion_text":"- Has Grade ≥2 peripheral neuropathy"}
  • {"criterion_text":"- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing"}
  • {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention"}
  • {"criterion_text":"- Has received prior neoadjuvant therapy for their current NSCLC diagnosis"}
  • {"criterion_text":"- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention"}
  • {"criterion_text":"- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids"}
  • {"criterion_text":"- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"DFS assessed by Blinded Independent Central Review (BICR) as stated in main objective and primary endpoint"}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) (standard definition: time from randomization to death from any cause) as listed"}
  • {"endpoint_text":"- Distant metastasis-free survival (DMFS) as assessed by investigator","definition_or_measurement_approach":"DMFS assessed by investigator (time to distant metastasis or death per investigator assessment)"}
  • {"endpoint_text":"- DFS as assessed by investigator","definition_or_measurement_approach":"Disease-free survival as assessed by investigator"}
  • {"endpoint_text":"- Lung cancer specific survival (LCSS)","definition_or_measurement_approach":"LCSS (survival specific to lung cancer)"}
  • {"endpoint_text":"- Number of participants who experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing one or more AEs"}
  • {"endpoint_text":"- Number of participants who discontinue study intervention due to AEs","definition_or_measurement_approach":"Count of participants discontinuing study intervention because of adverse events"}
  • {"endpoint_text":"- Change from Baseline in Global health status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-C30 global health status/QoL (Items 29 and 30)"}
  • {"endpoint_text":"- Change from Baseline in Physical functioning score (QLQ-C30 Items 1 to 5)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-C30 physical functioning (Items 1–5)"}
  • {"endpoint_text":"- Change from Baseline in Role functioning score (QLQ-C30 Items 6 and 7)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-C30 role functioning (Items 6 and 7)"}
  • {"endpoint_text":"- Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-C30 dyspnea (Item 8)"}
  • {"endpoint_text":"- Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-LC24 coughing items (Items 31 and 52)"}
  • {"endpoint_text":"- Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-LC24 chest pain (Item 40)"}

Recruitment

Planned Sample Size
536
Recruitment Window Months
126
Consent Approach
Informed consent obtained from adult participants via country-specific informed consent forms. Multiple language ICFs are provided (examples include English, Spanish, Greek, Norwegian, Portuguese, Dutch, French, Italian, Polish, Czech among others). Optional informed consent documents available for pregnancy follow-up and optional partner/pregnant partner consent; genetic consent documents available in some countries (e.g. Portugal). No assent/parental consent for minors is specified in CTIS records.

Geography

Total Number Of Sites
98
Total Number Of Participants
258

Spain

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
780
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Principal Investigator Name
Carlos Aguado de la Rosa
Principal Investigator Email
carlos.aguadodela@salud.madrid.org
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Alexandre Martinez Martí
Principal Investigator Email
amarinezmarti@vhio.net
Contact Person Name
Alexandre Martinez Martí
Contact Person Email
amarinezmarti@vhio.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology
Principal Investigator Name
Luis Angel León Mateos
Principal Investigator Email
Luis.Angel.Leon.Mateos@sergas.es
Contact Person Name
Luis Angel León Mateos
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Principal Investigator Name
Belen Rubio Viqueira
Principal Investigator Email
ensayosoncologia.mad@quironsalud.es
Contact Person Name
Belen Rubio Viqueira
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
contactfortrialsICOLH@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Principal Investigator Name
DELVYS RODRIGUEZ ABREU
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
DELVYS RODRIGUEZ ABREU
Contact Person Email
drodabr@gobiernodecanarias.org

Greece

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
781
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Athens Medical Center S.A.
Department Name
Οncology Department
Principal Investigator Name
Vasileios Ramfidis
Principal Investigator Email
ramfidis@gmail.com
Contact Person Name
Vasileios Ramfidis
Contact Person Email
ramfidis@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine-Oncology
Principal Investigator Name
Sofia Agelaki
Principal Investigator Email
agelaki@uoc.gr
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@uoc.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Department of Internal Medicine
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Metaxa Cancer Center Hospital Of Piraeus
Department Name
Pathology - Oncοlogy Clinic
Principal Investigator Name
Evangelos - Georgios Fergadis
Principal Investigator Email
fergadis@metaxa-hospital.gr
Contact Person Name
Evangelos - Georgios Fergadis
Contact Person Email
fergadis@metaxa-hospital.gr
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
koutras@uop.gr
Contact Person Name
Angelos Koutras
Contact Person Email
koutras@uop.gr
Site Name
Athens Medical Center S.A. (Thessaloniki)
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
General University Hospital Of Larissa
Department Name
A’ Pathological Sector - Oncology Clinic
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@uth.gr
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@uth.gr
Site Name
Athens Medical Center S.A. (Pylea)
Department Name
Oncology Department
Principal Investigator Name
Apostolos Laskarakis
Principal Investigator Email
aplaskarakis@gmail.com
Contact Person Name
Apostolos Laskarakis
Contact Person Email
aplaskarakis@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
709
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Vestre Viken HF
Department Name
Department of oncology
Principal Investigator Name
Odd Terje Brustugun
Principal Investigator Email
otr@vestreviken.no
Contact Person Name
Odd Terje Brustugun
Contact Person Email
otr@vestreviken.no
Site Name
Oslo University Hospital HF
Department Name
Department of Oncology, Radiumhospitalet
Principal Investigator Name
Vilde Haakensen
Principal Investigator Email
vdd@ous-hf.no
Contact Person Name
Vilde Haakensen
Contact Person Email
vdd@ous-hf.no
Site Name
Sykehuset Innlandet HF
Department Name
Department of Oncology and Center for Palliative Care Division Gjøvik
Principal Investigator Name
Daniel Heinrich
Principal Investigator Email
daniel.heinrich@sykehuset-innlandet.no
Contact Person Name
Daniel Heinrich
Site Name
Akershus University Hospital
Department Name
Department for lung diseases
Principal Investigator Name
Naumann Kirill
Principal Investigator Email
kirill.neumann@ahus.no
Contact Person Name
Naumann Kirill
Contact Person Email
kirill.neumann@ahus.no

Portugal

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
714
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Sara Póvoa
Principal Investigator Email
fatimamarques@ipocoimbra.min-saude.pt
Contact Person Name
Sara Póvoa
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Serviço de Pneumologia
Principal Investigator Name
Paula Alves
Principal Investigator Email
contactcenter@chln.min-saude.pt
Contact Person Name
Paula Alves
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Fernanda Estevinho
Principal Investigator Email
fernanda.estevinho@ulsm.min-saude.pt
Contact Person Name
Fernanda Estevinho
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Isabel Azevedo
Principal Investigator Email
clinicalstudies@ipoporto.min-saude.pt
Contact Person Name
Isabel Azevedo

Netherlands

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
711
Number Of Sites
8
Number Of Participants
11

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Longziekten
Principal Investigator Name
Egbert Smit
Principal Investigator Email
e.f.smit@lumc.nl
Contact Person Name
Egbert Smit
Contact Person Email
e.f.smit@lumc.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Wetenschappelijk Instituut
Principal Investigator Name
Wouter Jacobs
Principal Investigator Email
wetenschap@mzh.nl
Contact Person Name
Wouter Jacobs
Contact Person Email
wetenschap@mzh.nl
Site Name
Amphia Hospital
Department Name
Longoncologie
Principal Investigator Name
Cornelis van der Leest
Principal Investigator Email
researchlongoncologie@amphia.nl
Contact Person Name
Cornelis van der Leest
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Longziekten
Principal Investigator Name
Joachim Aerts
Principal Investigator Email
research.longziekten@erasmusmc.nl
Contact Person Name
Joachim Aerts
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Longziekten
Principal Investigator Name
Lisanne Kastelijn
Principal Investigator Email
rdlongoncologie@antoniusziekenhuis.nl
Contact Person Name
Lisanne Kastelijn
Site Name
Universitair Medisch Centrum Groningen
Department Name
longoncologie
Principal Investigator Name
T.J.N (Jeroen) Hiltermann
Principal Investigator Email
t.j.n.hiltermann@umcg.nl
Contact Person Name
T.J.N (Jeroen) Hiltermann
Contact Person Email
t.j.n.hiltermann@umcg.nl
Site Name
Isala Klinieken Stichting
Department Name
Longziekten
Principal Investigator Name
Peter Plomp
Principal Investigator Email
n.boeve@mediflowresearch.nl
Contact Person Name
Peter Plomp
Contact Person Email
n.boeve@mediflowresearch.nl
Site Name
Meander Medisch Centrum Stichting
Department Name
Longziekten
Principal Investigator Name
Judith Herder
Principal Investigator Email
longtrial@meandermc.nl
Contact Person Name
Judith Herder
Contact Person Email
longtrial@meandermc.nl

Belgium

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
708
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Service de Pneumologie - Oncologie Thoracique & Pneumologie Interventionnelle
Principal Investigator Name
Sebahat Ocak
Principal Investigator Email
sebahat.ocak@chuuclnamur.uclouvain.be
Contact Person Name
Sebahat Ocak
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Research Unit oncology
Principal Investigator Name
Jo Raskin
Principal Investigator Email
jo.raskin@uza.be
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
Vitaz
Department Name
Pulmonary diseases department
Principal Investigator Name
Koenraad Deschepper
Principal Investigator Email
koen.deschepper@vitaz.be
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be

Czechia

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
701
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Masarykův onkologický ústav, Klinika komplexní onkologické péče
Principal Investigator Name
Ondřej Bílek
Principal Investigator Email
bilek@mou.cz
Contact Person Name
Ondřej Bílek
Contact Person Email
bilek@mou.cz
Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Nemocnice AGEL Ostrava – Vítkovice, Plicní oddělení
Principal Investigator Name
Jaromír Roubec
Principal Investigator Email
jaromir.roubec@vtn.agel.cz
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz

Romania

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
784
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Cardiomed S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Calin Cainap
Principal Investigator Email
office@cardiomedcluj.ro
Contact Person Name
Calin Cainap
Contact Person Email
office@cardiomedcluj.ro
Site Name
Spitalul Clinic Municipal De Urgenta Timisoara
Department Name
Medical Oncology
Principal Investigator Name
Petra Curescu
Principal Investigator Email
secretariat@smtm.ro
Contact Person Name
Petra Curescu
Contact Person Email
secretariat@smtm.ro
Site Name
Delta Health Care S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Andrea Craciunescu
Principal Investigator Email
office.ponderas@reginamaria.ro
Contact Person Name
Andrea Craciunescu
Contact Person Email
office.ponderas@reginamaria.ro
Site Name
Onco Card S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Bogdan Carlan
Principal Investigator Email
office@oncocard.ro
Contact Person Name
Bogdan Carlan
Contact Person Email
office@oncocard.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology
Principal Investigator Name
Raluca Mihaila
Principal Investigator Email
secretariat@iob.ro
Contact Person Name
Raluca Mihaila
Contact Person Email
secretariat@iob.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Medical Oncology
Principal Investigator Name
Teodora-Alexa Stratulat
Principal Investigator Email
oncoiasi@iroiasi.ro
Contact Person Name
Teodora-Alexa Stratulat
Contact Person Email
oncoiasi@iroiasi.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
office.cluj@amethyst-radiotherapy.ro
Contact Person Name
Andrei Ungureanu
Site Name
Elias University Emergency Hospital
Department Name
Medical Oncology
Principal Investigator Name
Cornelia Nitipir
Principal Investigator Email
contact@spitalul-elias.ro
Contact Person Name
Cornelia Nitipir
Contact Person Email
contact@spitalul-elias.ro
Site Name
Mnt Healthcare Europe S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Bogdan Georgescu
Principal Investigator Email
office@neolife.ro
Contact Person Name
Bogdan Georgescu
Contact Person Email
office@neolife.ro
Site Name
Spitalul De Oncologie Monza S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Ingrid Iordan
Principal Investigator Email
office@enayati.ro
Contact Person Name
Ingrid Iordan
Contact Person Email
office@enayati.ro

Germany

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
715
Number Of Sites
12
Number Of Participants
44

Sites

Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Lungenklinik Heckeshorn, Klinik für Pneumologie
Principal Investigator Name
Daniel Misch
Principal Investigator Email
studienbuero-evb@helios-gesundheit.de
Contact Person Name
Daniel Misch
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie und Infektiologie
Principal Investigator Name
Hubert Wirtz
Principal Investigator Email
Hubert.Wirtz@medizin.uni-leipzig.de
Contact Person Name
Hubert Wirtz
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie
Principal Investigator Name
Karsten Schulmann
Principal Investigator Email
Karsten.Schulmann@lkhemer.de
Contact Person Name
Karsten Schulmann
Contact Person Email
Karsten.Schulmann@lkhemer.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Onkologie und Gastroenterologie, Hämatologie, Palliativmedizin
Principal Investigator Name
Jörg-Christian Rath
Principal Investigator Email
joerg-christian.rath@vivantes.de
Contact Person Name
Jörg-Christian Rath
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für Internistische Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Ekkehardt Eigendorff
Principal Investigator Email
studien@zentralklinik.de
Contact Person Name
Ekkehardt Eigendorff
Contact Person Email
studien@zentralklinik.de
Site Name
Katholisches Klinikum Koblenz Montabaur gGmbH
Department Name
Innere Medizin, Hämatologie und Onkologie Marienhof Koblenz
Principal Investigator Name
Frank Müller
Principal Investigator Email
f.mueller@bbtgruppe.de
Contact Person Name
Frank Müller
Contact Person Email
f.mueller@bbtgruppe.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Martin Faehling
Principal Investigator Email
studienpneumo@klinikum-esslingen.de
Contact Person Name
Martin Faehling
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
2. Medizinische Klinik
Principal Investigator Name
Dagmar Täuscher
Principal Investigator Email
studienzentrum.wkg@srh.de
Contact Person Name
Dagmar Täuscher
Contact Person Email
studienzentrum.wkg@srh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Fächerverbund für Infektiologie, Pneumologie und Intensivmedizin, Lungetumorambulanz
Principal Investigator Name
Nikolaj Frost
Principal Investigator Email
studien-pneumologie@charite.de
Contact Person Name
Nikolaj Frost
Contact Person Email
studien-pneumologie@charite.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Med II / Pneumologie
Principal Investigator Name
Christian Schulz
Principal Investigator Email
christian.schulz@ukr.de
Contact Person Name
Christian Schulz
Contact Person Email
christian.schulz@ukr.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Wolfgang Schütte
Principal Investigator Email
wolfgang.schuette@martha-maria.de
Contact Person Name
Wolfgang Schütte
Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Christian Grohé
Principal Investigator Email
christian.grohe@pgdiakonie.de
Contact Person Name
Christian Grohé
Contact Person Email
christian.grohe@pgdiakonie.de

Italy

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
712
Number Of Sites
15
Number Of Participants
33

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica di Oncologia Medica
Principal Investigator Name
Carlo Genova
Principal Investigator Email
carlo.genova@hsanmartino.it
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
UO Oncologia Medica
Principal Investigator Name
Chiara Catania
Principal Investigator Email
chiara.catania@gavazzeni.it
Contact Person Name
Chiara Catania
Contact Person Email
chiara.catania@gavazzeni.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Principal Investigator Name
Giuseppe Lo Russo
Principal Investigator Email
giuseppe.lorusso@istitutotumori.mi.it
Contact Person Name
Giuseppe Lo Russo
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Medica e Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC 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 Ospedaliero Universitaria Parma
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Medical Oncology and Hematology Unit
Principal Investigator Name
Alessandro Russo
Principal Investigator Email
alessandro.russo@humanitascatania.it
Contact Person Name
Alessandro Russo
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Oncology
Principal Investigator Name
Letizia Gianoncelli
Contact Person Name
Letizia Gianoncelli
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica 2
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SSD di Patologia Toracica
Principal Investigator Name
Angelo Del Monte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Del Monte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Antonello Veccia
Principal Investigator Email
antonello.veccia@apss.tn.it
Contact Person Name
Antonello Veccia
Contact Person Email
antonello.veccia@apss.tn.it

France

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
712
Number Of Sites
10
Number Of Participants
33

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de pneumologie
Principal Investigator Name
Jacques Cadranel
Principal Investigator Email
jacques.cadranel@aphp.fr
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Département de pneumologie
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
Direction Centrale Du Service De Sante Des Armees
Department Name
Département Respiratoire
Principal Investigator Name
Olivier Bylicki
Principal Investigator Email
Olivier.bylicki@intradef.gouv.fr
Contact Person Name
Olivier Bylicki
Site Name
Assoc Hospitaliere Nord Artois Clinique
Department Name
Service de pneumologie
Principal Investigator Name
Thomas Gey
Principal Investigator Email
tgey@ahnac.com
Contact Person Name
Thomas Gey
Contact Person Email
tgey@ahnac.com
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de cancérologie et d'imagerie
Principal Investigator Name
Gilles Quere
Principal Investigator Email
gilles.quere@chu-brest.fr
Contact Person Name
Gilles Quere
Contact Person Email
gilles.quere@chu-brest.fr
Site Name
Centre Jean Perrin
Department Name
Département d'oncologie
Principal Investigator Name
Pascale Dubray-Longeras
Contact Person Name
Pascale Dubray-Longeras
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Département de pneumologie
Principal Investigator Name
Thomas Egenod
Principal Investigator Email
Thomas.egenod@chu-limoges.fr
Contact Person Name
Thomas Egenod
Contact Person Email
Thomas.egenod@chu-limoges.fr
Site Name
Hospices Civils De Lyon
Department Name
Département de pneumologie
Principal Investigator Name
Thomas Pierret
Principal Investigator Email
Thomas.pierret@chu-lyon.fr
Contact Person Name
Thomas Pierret
Contact Person Email
Thomas.pierret@chu-lyon.fr
Site Name
CHU De Rouen
Department Name
Département de pneumologie
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
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Department Name
Département de pneumologie
Principal Investigator Name
Charles Naltet
Principal Investigator Email
cnaltet@ghpsj.fr
Contact Person Name
Charles Naltet
Contact Person Email
cnaltet@ghpsj.fr

Poland

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
714
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
II Klinika Chorób Płuc, Raka Płuca i Chorób Wewnętrznych
Principal Investigator Name
Robert Mróz
Principal Investigator Email
pulmonolog2@uskwb.pl
Contact Person Name
Robert Mróz
Contact Person Email
pulmonolog2@uskwb.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Principal Investigator Name
Tomasz Jankowski
Principal Investigator Email
cwbk@umlub.pl
Contact Person Name
Tomasz Jankowski
Contact Person Email
cwbk@umlub.pl
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
poznan@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
poznan@wcpit.org
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Iwona Zakrzewska
Principal Investigator Email
bco@onkologia.bialystok.pl
Contact Person Name
Iwona Zakrzewska
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
paulina.kukwa@nio.gov.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@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@pulmonologia.olsztyn.pl
Contact Person Name
Jarosław Kołb-Sielecki
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Anna Wrona
Principal Investigator Email
onkol@gumed.edu.pl
Contact Person Name
Anna Wrona
Contact Person Email
onkol@gumed.edu.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chirurgii Klatki Piersiowej i Chirurgii Onkologicznej
Principal Investigator Name
Piotr Kocoń
Principal Investigator Email
kaniutek98@gmail.com
Contact Person Name
Piotr Kocoń
Contact Person Email
kaniutek98@gmail.com
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Principal Investigator Name
Anna Łowczak
Principal Investigator Email
sekretariat@szpitalprabuty.pl
Contact Person Name
Anna Łowczak
Contact Person Email
sekretariat@szpitalprabuty.pl
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

Austria

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
714
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Wiener Gesundheitsverbund
Department Name
Klinik Penzing Abteilung für Atemwegs- und Lungenkrankheiten
Principal Investigator Name
Marie-Kathrin Breyer
Principal Investigator Email
marie-kathrin.breyer@gesundheitsverbund.at
Contact Person Name
Marie-Kathrin Breyer
Site Name
Medizinische Universitaet Innsbruck
Department Name
Medizinische Universität Innsbruck Hämatologie und Onkologie
Principal Investigator Name
Andreas Pircher
Principal Investigator Email
andreas.pircher@tirol-kliniken.at
Contact Person Name
Andreas Pircher
Site Name
Ordensklinikum Linz GmbH
Department Name
Ordensklinikum Linz GmbH – Elisabethinen Lungenabteilung / Pneumologie
Principal Investigator Name
Michael Schumacher
Principal Investigator Email
michael.schumacher@ordensklinkum.at
Contact Person Name
Michael Schumacher
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Signant Health Global Solutions Limited
Responsibilities
3
Name
Eresearchtechnology Inc.
Responsibilities
7
Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Labcorp Central Laboratory Services SARL
Responsibilities
4

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"American College Of Radiology Inc.","duties_or_roles":"Central imaging","organisation_type":"Patient organisation/association"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"American College Of Radiology Inc","duties_or_roles":"Central imaging","organisation_type":"Health care"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
4 mg/kg (maxDailyDoseAmount as listed: 4 mg/kg)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Marketing authorisation: EU/1/15/1024/002
Maximum Dose
400 mg (maxDailyDoseAmount as listed: 400 mg)
Combination Treatment
Yes

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