Clinical trial • Phase III • Oncology

TRASTUZUMAB DERUXTECAN for Non-squamous non-small cell lung cancer | HER2 positive non-small cell lung cancer

Phase III trial of TRASTUZUMAB DERUXTECAN for Non-squamous non-small cell lung cancer | HER2 positive non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-squamous non-small cell lung cancer | HER2 positive non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
13-06-2025
First CTIS Authorization Date
06-10-2025

Trial design

Randomised, open-label, pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab. (pemetrexed listed with maxdailydose 500 mg/m2; cisplatin maxdailydose 75 mg/m2; carboplatin maxdailydose 75 mg; pembrolizumab listed with maxdailydose 200 mg.)-controlled Phase III trial in France, Greece, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab. (Pemetrexed listed with maxDailyDose 500 mg/m2; cisplatin maxDailyDose 75 mg/m2; carboplatin maxDailyDose 75 mg; pembrolizumab listed with maxDailyDose 200 mg.)
Biomarker Stratified
True, HER2 overexpression and PD-L1 TPS (<50%)
Target Sample Size
686

Eligibility

Recruits 686 Participants must be adults (≥18 years). Informed consent is required: participants must sign the Tissue Screening ICF, the Main ICF, and the Optional PGx ICF prior to the respective procedures; a Pregnant Partner ICF is provided where applicable. Local regulatory requirements for legal age of consent apply (the protocol states to follow local rules if legal consent age >18). No procedures for assent of minors are described in the available documentation..

Vulnerable Population
Participants must be adults (≥18 years). Informed consent is required: participants must sign the Tissue Screening ICF, the Main ICF, and the Optional PGx ICF prior to the respective procedures; a Pregnant Partner ICF is provided where applicable. Local regulatory requirements for legal age of consent apply (the protocol states to follow local rules if legal consent age >18). No procedures for assent of minors are described in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.\n- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.\n- Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC and meets all of the following criteria: Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology. Mixed tumors will be classified based on the predominant cell type.\n- Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy. a. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I. b. HER2-targeted antibody-based anticancer therapy\n- Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor specified laboratory. A new biopsy is required if the participant’s most recent archival tumor tissue sample cannot be supplied."}

Exclusion criteria

  • {"criterion_text":"- Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.\n- Has a QTc prolongation to >480 ms based on the average of the Screening triplicate 12- lead ECG.\n- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.\n- Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).\n- Had a prior complete pneumonectomy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) by BICR. PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.","definition_or_measurement_approach":"PFS measured as time from randomization to radiographic disease progression or death; tumor response assessed by blinded independent review committee (BICR) using RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"OS measured as time from randomization to death from any cause."}

Other endpoints

  • {"endpoint_text":"- To assess the safety and tolerability.\n- To evaluate patient reported symptoms, functioning, and overall health status.","definition_or_measurement_approach":"Safety and tolerability assessed through collection of adverse events, laboratory and clinical assessments. Patient-reported outcomes assessed using symptom/functioning/overall health questionnaires (protocol references PGI, EORTC instruments and EQ-5D-5L among listed questionnaires)."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include digital patient brochures, digital pre-enrollment information cards, email communications, digital patient study guides, and ePRO/digital PRO capture (documents referencing digital brochures and email communications and Scout digital materials).
Planned Sample Size
686
Recruitment Window Months
78
Consent Approach
Informed consent obtained from participants (adults ≥18) via documented ICFs: Tissue Screening ICF, Main ICF, Optional PGx ICF (included in Main Screening ICF), and Pregnant Partner ICF where applicable. The protocol specifies following local regulatory requirements if the legal age of consent for trial participation is >18. Subject information and consent forms are provided in multiple languages (examples: English, French, Greek, Spanish, Italian, Portuguese, Romanian, Polish, Dutch) as per country-specific documents.

Methods

  • Physician referral letters and Dr-to-Patient letters distributed via healthcare professionals (documents: Physician Referral Letter, Dr-to-Patient Letter).
  • Patient brochures and digital patient brochures (K2 digital patient brochure) for potential participants.
  • Patient posters and pre-enrollment information cards displayed in sites.
  • Site toolkits, HCP fact sheets, and investigator/site engagement materials (site toolkit information card, HCP pocket guide).
  • Local-language country-specific recruitment materials (EN, FR, DE, ES, IT, PT, RO, PL, GR, NL) and patient guides tailored per country.
  • Scout program materials including Scout participant information card, Scout brochure, email communication and newsletters for outreach.
  • Use of ePRO and digital PRO collection and communications (ePRO statements, digital patient materials).

Geography

Total Number Of Sites
86
Total Number Of Participants
159

France

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
256
Number Of Sites
16
Number Of Participants
24

Sites

Site Name
Hopital Ambroise Pare
Department Name
Maladies respiratoires et oncologie thoracique
Principal Investigator Name
Etienne GIROUX-LEPRIEUR
Principal Investigator Email
etienne.giroux-leprieur@aphp.f
Contact Person Name
Etienne GIROUX-LEPRIEUR
Contact Person Email
etienne.giroux-leprieur@aphp.f
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie
Principal Investigator Name
Catherine BECHT
Principal Investigator Email
becht@ccgm.fr
Contact Person Name
Catherine BECHT
Contact Person Email
becht@ccgm.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie
Principal Investigator Name
Judith RAIMBOURG
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith RAIMBOURG
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie
Principal Investigator Name
Coureche KADERBHAI
Principal Investigator Email
cgkaderbhai@cgfl.fr
Contact Person Name
Coureche KADERBHAI
Contact Person Email
cgkaderbhai@cgfl.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pneumologie
Principal Investigator Name
Christos CHOUAID
Principal Investigator Email
cristos.chouaid@chicreteil.fr
Contact Person Name
Christos CHOUAID
Contact Person Email
cristos.chouaid@chicreteil.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
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
Institut Bergonie
Department Name
Oncologie
Principal Investigator Name
Sophie COUSIN
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Hopital Tenon
Department Name
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
Inst Medecine Epidemiologie Appliquee
Department Name
Pneumologie
Principal Investigator Name
Gerard ZALCMAN
Principal Investigator Email
gerard.zalcman@aphp.fr
Contact Person Name
Gerard ZALCMAN
Contact Person Email
gerard.zalcman@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie
Principal Investigator Name
Elvire PONS-TOSTIVINT
Principal Investigator Email
elvire.pons@chu-nantes.fr
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumologie
Principal Investigator Name
Youssef OULKHOUIR
Principal Investigator Email
youssef.oulkhouir@chu-angers.fr
Contact Person Name
Youssef OULKHOUIR
Site Name
Hopital Cardiologique
Department Name
Pneumologie
Principal Investigator Name
Alexis CORTOT
Principal Investigator Email
alexis.cortot@chu-lille.fr
Contact Person Name
Alexis CORTOT
Contact Person Email
alexis.cortot@chu-lille.fr
Site Name
Centre Leon Berard
Department Name
Oncologie
Principal Investigator Name
Maurice PEROL
Principal Investigator Email
maurice.perol@lyon.unicancer.fr
Contact Person Name
Maurice PEROL
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie
Principal Investigator Name
Pascale TOMASINI
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale TOMASINI
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Oncologie
Principal Investigator Name
Cyriac BLONZ
Principal Investigator Email
blonz.cyriac@groupeconfluent.fr
Contact Person Name
Cyriac BLONZ
Site Name
Hospices Civils De Lyon
Department Name
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

Greece

Earliest CTIS Part Ii Submission Date
30-06-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
294
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Metaxa Cancer Center Hospital Of Piraeus
Department Name
Department of Medical Oncology
Principal Investigator Name
Evangelos Fergadis
Principal Investigator Email
fergadis@metaxa-hospital.gr
Contact Person Name
Evangelos Fergadis
Contact Person Email
fergadis@metaxa-hospital.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Department of Medical Oncology, Aristotle University of Thessaloniki
Principal Investigator Name
Elena Timotheadou
Principal Investigator Email
timotheadoue@gmail.com
Contact Person Name
Elena Timotheadou
Contact Person Email
timotheadoue@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
4th Department of Medical Oncology
Principal Investigator Name
Ippokratis Korantzis
Principal Investigator Email
Ippokratis.korantzis@gmail.com
Contact Person Name
Ippokratis Korantzis
Contact Person Email
Ippokratis.korantzis@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@upatras.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@upatras.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Elena Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Elena Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Metropolitan Hospital
Department Name
4th Oncology Department
Principal Investigator Name
Elena Linardou
Principal Investigator Email
elinardou@metropolitan-hospital.gr
Contact Person Name
Elena Linardou
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine and Laboratory
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
University General Hospital Attikon
Department Name
2nd Department of Internal Medicine-Propaedeutic
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
psyrri237@yahoo.com
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Clinic
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 University Hospital Of Larissa
Department Name
Department of Medical Oncology
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@uth.gr
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@uth.gr

Belgium

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
234
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
CHU Helora (Mons)
Department Name
Oncology
Principal Investigator Name
Stéphane Holbrechts
Principal Investigator Email
Stephane.Holbrechts@helora.be
Contact Person Name
Stéphane Holbrechts
Contact Person Email
Stephane.Holbrechts@helora.be
Site Name
Grand Hopital De Charleroi
Department Name
Pneumology
Principal Investigator Name
Benoît Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoît Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
CHU Helora (La Louviere)
Department Name
Oncology
Principal Investigator Name
Catala Gaetan
Principal Investigator Email
gaetan.catala@jolimont.be
Contact Person Name
Catala Gaetan
Contact Person Email
gaetan.catala@jolimont.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Pneumology and Allergology
Principal Investigator Name
Astrid Paulus
Principal Investigator Email
apaulus@chuliege.be
Contact Person Name
Astrid Paulus
Contact Person Email
apaulus@chuliege.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pneumology
Principal Investigator Name
Annelies Janssens
Principal Investigator Email
annelies.janssens@uza.be
Contact Person Name
Annelies Janssens
Contact Person Email
annelies.janssens@uza.be

Poland

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
219
Number Of Sites
4
Number Of Participants
7

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
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Kliniczny Oddział Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorób Wewnętrznych
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
izachm@wp.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
izachm@wp.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Department Name
Provita Prolife
Principal Investigator Name
Magdalena Ciążyńska
Principal Investigator Email
magdalena.ciazynska@nu-med.pl
Contact Person Name
Magdalena Ciążyńska
Contact Person Email
magdalena.ciazynska@nu-med.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Principal Investigator Name
Anna Drosik-Kwaśniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.pl
Contact Person Name
Anna Drosik-Kwaśniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl

Romania

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
215
Number Of Sites
10
Number Of Participants
16

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncologie Medicala
Principal Investigator Name
Mihai-Vasile Marinca
Principal Investigator Email
marincarct@gmail.com
Contact Person Name
Mihai-Vasile Marinca
Contact Person Email
marincarct@gmail.com
Site Name
Radiology Therapeutic Center S.R.L.
Department Name
Oncologie
Principal Investigator Name
Elena Ciubotaru
Principal Investigator Email
elena.ciubotaru@amethyst-radiotherapy.com
Contact Person Name
Elena Ciubotaru
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Principal Investigator Name
Alina Simona Muntean
Principal Investigator Email
muntean.alina@yahoo.fr
Contact Person Name
Alina Simona Muntean
Contact Person Email
muntean.alina@yahoo.fr
Site Name
Spital Clinic Militar De Urgenta Dr. Constantin Papilian Cluj Napoca
Department Name
Oncologie Medicala
Principal Investigator Name
Georgeta Crisan
Principal Investigator Email
oncogcrisan@yahoo.com
Contact Person Name
Georgeta Crisan
Contact Person Email
oncogcrisan@yahoo.com
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie
Principal Investigator Name
Amedeia Nita
Principal Investigator Email
amedeianita@yahoo.com
Contact Person Name
Amedeia Nita
Contact Person Email
amedeianita@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Delta Health Care S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Andrea Craciunescu
Principal Investigator Email
deea06@yahoo.com
Contact Person Name
Andrea Craciunescu
Contact Person Email
deea06@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Oncologie
Principal Investigator Name
Andrei Popescu
Principal Investigator Email
andreipopescu1983@gmail.com
Contact Person Name
Andrei Popescu
Contact Person Email
andreipopescu1983@gmail.com
Site Name
Memorial Healthcare International S.R.L.
Department Name
Oncologie Medicala
Principal Investigator Name
Ingrid Iordan
Principal Investigator Email
mireliordan@yahoo.com
Contact Person Name
Ingrid Iordan
Contact Person Email
mireliordan@yahoo.com
Site Name
Spital Clinic Colentina Bucuresti (additional listed site entries exist)
Department Name
Oncologie

Germany

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
220
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Heidelberg University
Department Name
Personalisierte Onkologie
Principal Investigator Name
Maike Collienne
Principal Investigator Email
maike.collienne@umm.de
Contact Person Name
Maike Collienne
Contact Person Email
maike.collienne@umm.de
Site Name
Universitaet Leipzig
Department Name
Pneumologie
Principal Investigator Name
Hubert Wirtz
Principal Investigator Email
hubert.wirtz@medizin.uni-leipzig.de
Contact Person Name
Hubert Wirtz
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@innere.med.uni-giessen.de
Contact Person Name
Thomas Wehler
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik
Principal Investigator Name
Juergen Alt
Principal Investigator Email
juergen.alt@unimedizin-mainz.de
Contact Person Name
Juergen Alt
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung)
Principal Investigator Name
Marcel Wiesweg
Principal Investigator Email
marcel.wiesweg@uk-essen.de
Contact Person Name
Marcel Wiesweg
Contact Person Email
marcel.wiesweg@uk-essen.de
Site Name
Klinikum Esslingen GmbH
Department Name
Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Martin Faehling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Faehling

Portugal

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
249
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
António Araújo
Principal Investigator Email
antonio.araujo@chporto.min-saude.pt
Contact Person Name
António Araújo
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pneumology
Principal Investigator Name
Andrea Machado
Principal Investigator Email
astl.machado@gmail.com
Contact Person Name
Andrea Machado
Contact Person Email
astl.machado@gmail.com
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology
Principal Investigator Name
Venceslau Hespanhol
Principal Investigator Email
venceslau.hespanhol@cuf.pt
Contact Person Name
Venceslau Hespanhol
Contact Person Email
venceslau.hespanhol@cuf.pt
Site Name
Hospital Da Luz S.A.
Department Name
Medical Oncology
Principal Investigator Name
João Moreira Pinto
Principal Investigator Email
joao.pmoreira.pinto@hospitaldaluz.pt
Contact Person Name
João Moreira Pinto

Spain

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
222
Number Of Sites
20
Number Of Participants
53

Sites

Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
Edurne Arriola Aperribay
Principal Investigator Email
earriola@parcdesalutmar.cat
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@parcdesalutmar.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Mónica Antoñanzas Basa
Principal Investigator Email
monica.antonanzas@salud.madrid.org
Contact Person Name
Mónica Antoñanzas Basa
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Rosa Álvarez Álvarez
Principal Investigator Email
rosa.alvarez.al@gmail.com
Contact Person Name
Rosa Álvarez Álvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Luis Ángel León Mateos
Principal Investigator Email
luis.leon.mateos@sergas.es
Contact Person Name
Luis Ángel León Mateos
Contact Person Email
luis.leon.mateos@sergas.es
Site Name
Hospital Universitario De Burgos
Department Name
Oncology
Principal Investigator Name
Cristina Bayona Antón
Principal Investigator Email
cbayona@saludcastillayleon.es
Contact Person Name
Cristina Bayona Antón
Contact Person Email
cbayona@saludcastillayleon.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Andrés Miler Cuellar Rivas
Principal Investigator Email
macuellar@iconcologia.net
Contact Person Name
Andrés Miler Cuellar Rivas
Contact Person Email
macuellar@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Jon Zugazagoitia Fraile
Principal Investigator Email
j.zugazagoitia.imas12@h12o.es
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
Andrés Aguilar Hernández
Principal Investigator Email
aaguilar@oncorosell.com
Contact Person Name
Andrés Aguilar Hernández
Contact Person Email
aaguilar@oncorosell.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Alexandra Cantero González
Principal Investigator Email
alexndracantero.eecc@gmail.com
Contact Person Name
Alexandra Cantero González
Contact Person Email
alexndracantero.eecc@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
José Carlos Benítez Montañez
Principal Investigator Email
josecarlos.benitez@ibima.eu
Contact Person Name
José Carlos Benítez Montañez
Contact Person Email
josecarlos.benitez@ibima.eu
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Principal Investigator Name
José Fuentes Pradera
Principal Investigator Email
fuentespradera@hotmail.com
Contact Person Name
José Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
María Rosario García Campelo
Principal Investigator Email
MA.Rosario.Garcia.Campelo@sergas.es
Contact Person Name
María Rosario García Campelo
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
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Principal Investigator Name
Delvys Rodríguez Abreu
Principal Investigator Email
delvysra@yahoo.com
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
delvysra@yahoo.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Principal Investigator Name
Sergio Vázquez Estévez
Principal Investigator Email
Sergio.Vazquez.Estevez@sergas.e
Contact Person Name
Sergio Vázquez Estévez
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Emilio Esteban González
Principal Investigator Email
eestebang@seom.org
Contact Person Name
Emilio Esteban González
Contact Person Email
eestebang@seom.org
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Sergio Sandiego Contreras
Principal Investigator Email
ssandiego@fivo.org
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Hospital General Universitario De Castellon
Department Name
Oncology
Principal Investigator Name
Alfredo Sánchez Hernández
Principal Investigator Email
asanchezh@seom.org
Contact Person Name
Alfredo Sánchez Hernández
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Javier De Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro Carpeño

Italy

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
214
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Oncology
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@sanita.marche.it
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanita.marche.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Oncology
Principal Investigator Name
Francesco Gelsomino
Principal Investigator Email
francesco_gelsomino@aosp.bo.it
Contact Person Name
Francesco Gelsomino
Contact Person Email
francesco_gelsomino@aosp.bo.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncology
Principal Investigator Name
Alessandro Russo
Principal Investigator Email
alessandro.russo@humanitascatania.it
Contact Person Name
Alessandro Russo
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncology
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology
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
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology
Principal Investigator Name
Giacomo Allegrini
Principal Investigator Email
giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name
Giacomo Allegrini
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Principal Investigator Name
Roberto Ferrara
Principal Investigator Email
roberto.ferrara@hsr.it
Contact Person Name
Roberto Ferrara
Contact Person Email
roberto.ferrara@hsr.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncology
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
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncology
Principal Investigator Name
Vanesa Gregorc
Principal Investigator Email
vanesa.gregorc@ircc.it
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncology
Principal Investigator Name
Gabriele Minuti
Principal Investigator Email
gabriele.minuti@ifo.it
Contact Person Name
Gabriele Minuti
Contact Person Email
gabriele.minuti@ifo.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Oncology
Principal Investigator Name
Veronica Crespi
Principal Investigator Email
veronica.crespi@asst-settelaghi.it
Contact Person Name
Veronica Crespi

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
1, 12, 13, 2, 5
Name
PPD Development LP
Responsibilities
PK/ADA Lab
Name
Fortrea Inc.
Responsibilities
6
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
1, 12

Third parties

  • {"country":"United States","full_name":"Agilent Technologies, Inc.","duties_or_roles":"PD-L1 manufacturer","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"HER-2 manufacturer","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Storage for future research","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROS; ILD Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Site engagement platform","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"1, 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"PK/ADA Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1, 12, 13, 2, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"CTDNA","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta (additional entry)","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
DS-8201a
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus=1
Maximum Dose
5.4 mg/kg
Combination Treatment
Yes

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