Clinical trial • Phase III • Oncology

DATOPOTAMAB DERUXTECAN for Non-small cell lung cancer (non-squamous, locally-advanced or metastatic)

Phase III trial of DATOPOTAMAB DERUXTECAN for Non-small cell lung cancer (non-squamous, locally-advanced or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (non-squamous, locally-advanced or metastatic)
Trial Stage
Phase III
Drug Modality
ADC | Bispecific antibody | Monoclonal antibody

Key dates

Initial CTIS Submission Date
11-03-2024
First CTIS Authorization Date
20-06-2024

Trial design

Randomised, open-label, pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion) — dose/schedule not specified in the ctis extract.-controlled Phase III trial in Germany, Italy, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion) — dose/schedule not specified in the CTIS extract.
Biomarker Stratified
True, TROP2 (TROP2 biomarker positive)
Target Sample Size
486

Eligibility

Recruits 486 Vulnerable population flag is set. Subject Information Sheets and Informed Consent Forms are provided for adult participants (multiple country/language versions) and for pregnant partners; biomarker screening and optional genetic research consent forms are available. No paediatric assent/consent procedures are described in the CTIS dataset..

Vulnerable Population
Vulnerable population flag is set. Subject Information Sheets and Informed Consent Forms are provided for adult participants (multiple country/language versions) and for pregnant partners; biomarker screening and optional genetic research consent forms are available. No paediatric assent/consent procedures are described in the CTIS dataset.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically documented non-squamous NSCLC."}
  • {"criterion_text":"- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation."}
  • {"criterion_text":"- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and abscence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies."}
  • {"criterion_text":"- Must provide an available FFPE tumour sample collected ≤ 3 months prior to the start of screening. If such a sample is not available, then a FFPE tumour sample will be collected at biomarker screening (if applicable) or main screening."}
  • {"criterion_text":"- Known tumour PD-L1 expression status defined as TC ≥ 50%, determined prospectively using an FFPE tumour sample collected using the VENTANA PD-L1 (SP263) Assay)."}
  • {"criterion_text":"- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline."}
  • {"criterion_text":"- ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior randomisation."}
  • {"criterion_text":"- Adequate bone marrow reserve and organ function as defined in inclusion criteria 13."}
  • {"criterion_text":"- Prior to the availability of the VENTANA TROP2 device, retrospective tumour material confirms eligibility. Once the VENTANA TROP2 device is available, prospective testing is implemented."}

Exclusion criteria

  • {"criterion_text":"- Prior systemic therapy for advanced/metastatic NSCLC."}
  • {"criterion_text":"- History of leptomeningeal carcinomatosis"}
  • {"criterion_text":"- Known clinically significant corneal disease"}
  • {"criterion_text":"- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled"}
  • {"criterion_text":"- History of active primary immunodeficiency"}
  • {"criterion_text":"- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant."}
  • {"criterion_text":"- History of another primary malignancy within 3 years."}
  • {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders (with exceptions)."}
  • {"criterion_text":"- Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, serious chronic gastrointestinal conditions, cardiac disease."}
  • {"criterion_text":"- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage."}
  • {"criterion_text":"- History of any ILD/pneumonitis, including radiation pneumonitis, or drug- induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening."}
  • {"criterion_text":"- Has significant pulmonary function compromise, as determined by the investigator"}
  • {"criterion_text":"- Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Assessment of PFS by BICR in TROP2 biomarker positive participants.","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) in participants positive for the TROP2 biomarker."}
  • {"endpoint_text":"- Assessment of OS in TROP2 biomarker positive participants.","definition_or_measurement_approach":"Overall survival (OS) measured in TROP2 biomarker positive participants (time to death from any cause)."}

Secondary endpoints

  • {"endpoint_text":"- Assessment of PFS by BICR in the FAS population.","definition_or_measurement_approach":"PFS assessed by BICR in the Full Analysis Set (FAS) population."}
  • {"endpoint_text":"- Assessment of OS in the FAS population.","definition_or_measurement_approach":"Overall survival measured in the Full Analysis Set (FAS) population."}
  • {"endpoint_text":"- Objective Response Rate (ORR), Duration of Response (DoR)","definition_or_measurement_approach":"Objective Response Rate and Duration of Response assessed per trial radiologic criteria (e.g., RECIST 1.1)."}
  • {"endpoint_text":"- Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab","definition_or_measurement_approach":"Participant-reported outcomes assessing lung cancer symptoms and Global Health Status/Quality of Life (GHS/QOL) comparing treatments."}
  • {"endpoint_text":"- Pharmacokinetics (PK)","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis for study drugs."}
  • {"endpoint_text":"- Immunogenicity","definition_or_measurement_approach":"Assessment of anti-drug antibodies and related immunogenicity measures."}
  • {"endpoint_text":"- Second Progression-Free Survival (PFS2)","definition_or_measurement_approach":"Time to second progression-free survival (PFS2) as defined in protocol."}
  • {"endpoint_text":"- Safety and tolerabillity evaluated in terms of AEs","definition_or_measurement_approach":"Safety and tolerability evaluated by recording adverse events (AEs)."}

Recruitment

Planned Sample Size
486
Recruitment Window Months
62
Consent Approach
Informed consent is obtained from adult participants. Subject Information Sheets and Informed Consent Forms are available in multiple country/language versions (examples in CTIS: German, Spanish, Hungarian, Polish, Dutch/French/English for BE, etc.). Specific ICFs are provided for adults, biomarker screening, optional genetic research, and pregnant partners. No paediatric assent or consent procedures are described in the CTIS data.

Methods

  • Site-based recruitment using recruitment pamphlets and posters (country-specific recruitment materials present in CTIS: pamphlets/posters and patient study guides for multiple Member States).

Geography

Total Number Of Sites
64
Total Number Of Participants
189

Germany

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
598
Number Of Sites
21
Number Of Participants
54

Sites

Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Principal Investigator Name
Konrad Kokowski
Principal Investigator Email
Konrad.Kokowski@muenchen-klinik.de
Contact Person Name
Konrad Kokowski
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Principal Investigator Name
Geothy Chakupurakal
Principal Investigator Email
chakupurakal@invo-koblenz.de
Contact Person Name
Geothy Chakupurakal
Contact Person Email
chakupurakal@invo-koblenz.de
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Principal Investigator Name
Roswitha Fuchs
Principal Investigator Email
dr.fuchs@onkologie-langen.de
Contact Person Name
Roswitha Fuchs
Contact Person Email
dr.fuchs@onkologie-langen.de
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Thorakale Onkologie
Principal Investigator Name
Niels Reinmuth
Principal Investigator Email
n.reinmuth@asklepios.com
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Klinikum Nuernberg
Department Name
Klinik für Innere Medizin 3
Principal Investigator Name
Wolfgang Brueckl
Principal Investigator Email
Wolfgang.Brueckl@klinikum-nuernberg.de
Contact Person Name
Wolfgang Brueckl
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Medizinische Klinik
Principal Investigator Name
Dagmar Taeuscher
Principal Investigator Email
taeuscher.studienzentrum@wkg.srh.de
Contact Person Name
Dagmar Taeuscher
Site Name
Franziskus Hospital Harderberg
Department Name
Sektion Thoraxonkologie
Principal Investigator Name
Petra Hoffknecht
Principal Investigator Email
petra.hoffknecht@niels-stensen-kliniken.de
Contact Person Name
Petra Hoffknecht
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Abteilung Pneumologie
Principal Investigator Name
Christian Schumann
Contact Person Name
Christian Schumann
Site Name
Johanniter GmbH
Principal Investigator Name
Yon-Dschun Ko
Principal Investigator Email
Yon-dschun.ko@bn.johanniter-kliniken.de
Contact Person Name
Yon-Dschun Ko
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Justyna Rawluk
Principal Investigator Email
justyna.rawluk@uniklinik-freiburg.de
Contact Person Name
Justyna Rawluk
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
Onkologische Tagesklinik
Principal Investigator Name
Gunnar Hapke
Principal Investigator Email
hapke.innere@marienkrankenhaus.org
Contact Person Name
Gunnar Hapke
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Thorakale Onkologie
Principal Investigator Name
Sebastian Ertl
Principal Investigator Email
s.ertl@kem-med.com
Contact Person Name
Sebastian Ertl
Contact Person Email
s.ertl@kem-med.com
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Matthias Paland
Principal Investigator Email
matthias.paland@klinikumevb.de
Contact Person Name
Matthias Paland
Contact Person Email
matthias.paland@klinikumevb.de
Site Name
Kaiserswerther Diakonie
Department Name
Onkologie
Principal Investigator Name
Mark Uhlenbruch
Principal Investigator Email
uhlenbruchm@kaiserswerther-diakonie.de
Contact Person Name
Mark Uhlenbruch
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Krebszentrum Nord-Württemberg
Principal Investigator Name
Matthias Ulmer
Principal Investigator Email
matthias.ulmer@rkh-kliniken.de
Contact Person Name
Matthias Ulmer
Contact Person Email
matthias.ulmer@rkh-kliniken.de
Site Name
Hämato-Onkologie Hamburg
Department Name
Studiengesellschaft
Principal Investigator Name
Eckart Laack
Principal Investigator Email
e.laack@haemato-onkologie-hh.de
Contact Person Name
Eckart Laack
Site Name
MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbH
Principal Investigator Name
Jan Phillip Weber
Principal Investigator Email
Weber@oncokoeln.de
Contact Person Name
Jan Phillip Weber
Contact Person Email
Weber@oncokoeln.de
Site Name
Studienzentrum Onkologie Ravensburg GmbH
Department Name
Onkologie
Principal Investigator Name
Tobias Dechow
Principal Investigator Email
dechow@onkonet.eu
Contact Person Name
Tobias Dechow
Contact Person Email
dechow@onkonet.eu
Site Name
Onkodok GmbH
Department Name
Onkologie
Principal Investigator Name
Philipp Schuett
Principal Investigator Email
schuett@onkologie-guetersloh.de
Contact Person Name
Philipp Schuett
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie
Principal Investigator Name
Helge Bischoff
Principal Investigator Email
helge.bischoff@med.uni-heidelberg.de
Contact Person Name
Helge Bischoff
Site Name
Vivantes MVZ GmbH
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Peter Thuss-Patience
Principal Investigator Email
Peter.Thuss@vivantes.de
Contact Person Name
Peter Thuss-Patience
Contact Person Email
Peter.Thuss@vivantes.de

Italy

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
369
Number Of Sites
10
Number Of Participants
34

Sites

Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Unità Operativa Complessa di 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
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncologia Medica
Principal Investigator Name
Diego Luigi Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Luigi Cortinovis
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Ematologia e Medicina Molecolare
Principal Investigator Name
Elio Gregory Pizzutilo
Principal Investigator Email
eliogregory.pizzutilo@ospedaleniguarda.it
Contact Person Name
Elio Gregory Pizzutilo
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncologia ed Ematologia Medica
Principal Investigator Name
Luca Toschi
Principal Investigator Email
luca.toschi@cancercenter.humanitas.it
Contact Person Name
Luca Toschi
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
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
Presidio Ospedaliero Humanitas Gavazzeni
Department Name
Oncologia Medica
Principal Investigator Name
Chiara Matilde Catania
Principal Investigator Email
chiara.catania@gavazzeni.it
Contact Person Name
Chiara Matilde Catania
Contact Person Email
chiara.catania@gavazzeni.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Oncologia Medica
Principal Investigator Name
Alessio Cortellini
Principal Investigator Email
a.cortellini@policlinicocampus.it
Contact Person Name
Alessio Cortellini
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Toracica
Principal Investigator Name
Filippo De Marinis
Principal Investigator Email
filippo.demarinis@ieo.it
Contact Person Name
Filippo De Marinis
Contact Person Email
filippo.demarinis@ieo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncologia Medica
Principal Investigator Name
Chiara Bennati
Principal Investigator Email
chiarabennati@libero.it
Contact Person Name
Chiara Bennati
Contact Person Email
chiarabennati@libero.it

Spain

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
578
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Noemi Reguart Aransay
Principal Investigator Email
NREGUART@clinic.cat
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
NREGUART@clinic.cat
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
bmassutis@seom.org
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology Service
Principal Investigator Name
Jesús Corral Jaime
Principal Investigator Email
jesuscorraljaime@hotmail.com
Contact Person Name
Jesús Corral Jaime
Contact Person Email
jesuscorraljaime@hotmail.com
Site Name
Salut Sant Joan De Reus
Department Name
Oncology Service
Principal Investigator Name
Cristina Martí Blanco
Principal Investigator Email
cristina.marti@salutsantjoan.cat
Contact Person Name
Cristina Martí Blanco
Site Name
Hospital Del Mar
Department Name
Oncology Service
Principal Investigator Name
Edurne Arriola Aperribay
Principal Investigator Email
earriola@psmar.cat
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@psmar.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology Service
Principal Investigator Name
Lorena Bellido Hernández
Principal Investigator Email
lbellido@saludcastillayleon.es
Contact Person Name
Lorena Bellido Hernández
Contact Person Email
lbellido@saludcastillayleon.es

Belgium

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
596
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Jessa Ziekenhuis
Department Name
Pneumology
Principal Investigator Name
Kristof Cuppens
Principal Investigator Email
kristof.cuppens@jessazh.be
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
CHU Helora
Department Name
Oncology
Principal Investigator Name
Geatan Catala
Principal Investigator Email
Gaetan.CATALA@jolimont.be
Contact Person Name
Geatan Catala
Contact Person Email
Gaetan.CATALA@jolimont.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Mariana Brandao
Principal Investigator Email
mariana.brandao@hubruxelles.be
Contact Person Name
Mariana Brandao
Contact Person Email
mariana.brandao@hubruxelles.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Pneumology
Principal Investigator Name
Lander Acker
Principal Investigator Email
pneumologie.brugge@azsintjan.be
Contact Person Name
Lander Acker
Site Name
CHC MontLegia
Department Name
Oncology
Principal Investigator Name
Maryam Bourhaba
Principal Investigator Email
mbourhaba@chu.ulg.ac.be
Contact Person Name
Maryam Bourhaba
Contact Person Email
mbourhaba@chu.ulg.ac.be

Hungary

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
665
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Matrai Gyogyintezet
Principal Investigator Name
István Albert
Principal Investigator Email
albert.magy@gmail.com
Contact Person Name
István Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Principal Investigator Name
Zsuzsanna Kelemen
Principal Investigator Email
study.zsuzsannadrkelemen@gmail.com
Contact Person Name
Zsuzsanna Kelemen
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkopulmonológiai Járóbeteg Centrum
Principal Investigator Name
Gabriella Gálffy
Principal Investigator Email
galffy.gabriella@torokbalintkorhaz.hu
Contact Person Name
Gabriella Gálffy
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológiai Osztály
Principal Investigator Name
Zsuzsanna Szalai
Principal Investigator Email
clinstudy@gmail.com
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Onkológiai Osztály
Principal Investigator Name
Yousuf Al-Farhat
Principal Investigator Email
yalfarhat@gmail.com
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Koranyi National Institute For Pulmonology
Department Name
XIV. Pulmonológiai Osztály
Principal Investigator Name
Szabolcs Sotersz
Principal Investigator Email
sotersz@freemail.hu
Contact Person Name
Szabolcs Sotersz
Contact Person Email
sotersz@freemail.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Aktív Tüdőgyógyászati
Principal Investigator Name
Ibolya Laczó
Principal Investigator Email
laczoibolya@gmail.com
Contact Person Name
Ibolya Laczó
Contact Person Email
laczoibolya@gmail.com
Site Name
Nograd Varmegyei Szent Lazar Korhaz
Department Name
Onkológia Centrum
Principal Investigator Name
László Landherr
Principal Investigator Email
landherr@szlmk.hu
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
I. Pulmonológiai Osztály
Principal Investigator Name
Zsolt Pápai-Székely
Principal Investigator Email
zsoltpapai@yahoo.com
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.com
Site Name
Reformatus Pulmonologiai Centrum (duplicate entry not specified)

Poland

Earliest CTIS Part Ii Submission Date
04-06-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
594
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododzialem Chemioterapii
Principal Investigator Name
Jaroslaw Kolb-Sielecki
Principal Investigator Email
sekretariat@pulmonologia.olsztyn.pl
Contact Person Name
Jaroslaw Kolb-Sielecki
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Onkologii Klinicznej z Pododzialem Dziennej Chemioterapii
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii
Principal Investigator Name
Kamil Kuc
Principal Investigator Email
kkuc@wszp.pl
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Pluca i Klatki Piersiowej
Principal Investigator Name
Adam Pluzanski
Principal Investigator Email
adam.pluzanski@nio.gov.pl
Contact Person Name
Adam Pluzanski
Contact Person Email
adam.pluzanski@nio.gov.pl
Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
3 Klinika Chorob Pluc i Onkologii
Principal Investigator Name
Mateusz Polaczek
Principal Investigator Email
m.polaczek@igichp.edu.pl
Contact Person Name
Mateusz Polaczek
Contact Person Email
m.polaczek@igichp.edu.pl

Austria

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
601
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Wiener Gesundheitsverbund
Department Name
Department of Respiratory and Lung Diseases
Principal Investigator Name
Marie-Kathrin Breyer
Principal Investigator Email
Marie-Kathrin.breyer@gesundheitsverbund.at
Contact Person Name
Marie-Kathrin Breyer
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Internal Medicine 4 - Pneumology
Principal Investigator Name
David Lang
Principal Investigator Email
David.Lang@kepleruniklinikum.at
Contact Person Name
David Lang
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic of Internal Medicine V
Principal Investigator Name
Florian Kocher
Principal Investigator Email
Florian.kocher@tirol-kliniken.at
Contact Person Name
Florian Kocher
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Department of Internal Medicine and Pneumology
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Internal E at LKH Rankweil
Principal Investigator Name
Thomas Winder
Principal Investigator Email
thomas.winder@lkhf.at
Contact Person Name
Thomas Winder
Contact Person Email
thomas.winder@lkhf.at
Site Name
Universitaetsklinikum Krems
Department Name
Department of Pneumology
Principal Investigator Name
Klaus Hackner
Principal Investigator Email
Klaus.Hackner@krems.lknoe.at
Contact Person Name
Klaus Hackner
Contact Person Email
Klaus.Hackner@krems.lknoe.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Pneumology
Principal Investigator Name
Christian Trockenbacher
Principal Investigator Email
christian.trockenbacher@klinikum-wegr.at
Contact Person Name
Christian Trockenbacher

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Not authorised (investigational)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation EU/1/15/1024/002)
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
INTRAVENOUS
Combination Treatment
Yes

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