Clinical trial • Phase III • Oncology

DATOPOTAMAB DERUXTECAN for EGFR-mutated non-small cell lung cancer | Non-squamous non-small cell lung cancer

Phase III trial of DATOPOTAMAB DERUXTECAN for EGFR-mutated non-small cell lung cancer | Non-squamous non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
EGFR-mutated non-small cell lung cancer | Non-squamous non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
07-11-2024

Trial design

Randomised, open-label, platinum-based doublet chemotherapy (cisplatin; carboplatin; pemetrexed) — specific doses and schedules not specified in the ctis record.-controlled Phase III trial in Belgium, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based doublet chemotherapy (CISPLATIN; CARBOPLATIN; PEMETREXED) — specific doses and schedules not specified in the CTIS record.
Target Sample Size
544

Eligibility

Recruits 544 Vulnerable population is selected in the record. Country-specific informed consent documents (L1 Country ICF Main and related L1 documents) are provided for participating countries in multiple languages (see country ICF documents). No specific assent/consent handling details for minors or other vulnerable subgroups are provided in the CTIS record content..

Vulnerable Population
Vulnerable population is selected in the record. Country-specific informed consent documents (L1 Country ICF Main and related L1 documents) are provided for participating countries in multiple languages (see country ICF documents). No specific assent/consent handling details for minors or other vulnerable subgroups are provided in the CTIS record content.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed non-squamous NSCLC."}
  • {"criterion_text":"- Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M)."}
  • {"criterion_text":"- Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting."}
  • {"criterion_text":"- Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI)."}
  • {"criterion_text":"- At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline."}
  • {"criterion_text":"- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
  • {"criterion_text":"- Adequate bone marrow reserve and organ function within 7 days before randomization."}

Exclusion criteria

  • {"criterion_text":"- Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the palliative setting. Platinum-based chemotherapy in curative setting within 12 months prior to randomization."}
  • {"criterion_text":"- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections."}
  • {"criterion_text":"- Has known human immunodeficiency virus (HIV) infection that is not well controlled."}
  • {"criterion_text":"- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention."}
  • {"criterion_text":"- Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease."}
  • {"criterion_text":"- Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage."}
  • {"criterion_text":"- History of ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening."}
  • {"criterion_text":"- Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses."}
  • {"criterion_text":"- Unstable spinal cord compression and/or unstable brain metastases."}
  • {"criterion_text":"- Participants with symptomatic brain metastases (including leptomeningeal involvement)."}
  • {"criterion_text":"- Clinically significant corneal disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS is defined as the time from randomization to BICR assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti cancer therapy, or clinical progression.","definition_or_measurement_approach":"Time from randomization to progression as assessed by Blinded Independent Central Review (BICR) using RECIST v1.1 or death from any cause; progression determined per RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) is defined as time from randomization until the date of death due to any cause. The comparison will include all randomized participants, as randomized, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy.","definition_or_measurement_approach":"Time from randomization to date of death from any cause; analyses include all randomized participants as randomized."}
  • {"endpoint_text":"- Central Nervous System Progression-free Survival (CNS PFS) is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR-confirmed CNS modified RECIST v1.1 progression.","definition_or_measurement_approach":"Time from randomization to BICR-confirmed CNS progression using CNS-modified RECIST v1.1 or death from any cause."}
  • {"endpoint_text":"- Objective Response Rate (ORR) is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1.","definition_or_measurement_approach":"Proportion with confirmed CR or PR per BICR using RECIST v1.1."}
  • {"endpoint_text":"- Duration of Response (DoR) is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause.","definition_or_measurement_approach":"Time from first documented response to documented progression per RECIST v1.1 by BICR or death."}
  • {"endpoint_text":"- Progression-free Survival-2 (PFS-2) is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death.","definition_or_measurement_approach":"Time from randomization to earliest progression event after first subsequent therapy following initial investigator-assessed progression, or death."}
  • {"endpoint_text":"- ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1.","definition_or_measurement_approach":"Proportion with confirmed CR or PR in CNS per CNS-modified RECIST v1.1 as assessed by BICR."}
  • {"endpoint_text":"- DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1.","definition_or_measurement_approach":"Time from first documented response to progression or death using CNS-modified RECIST v1.1."}
  • {"endpoint_text":"- Time to deterioration (in pulmonary symptoms [dyspnea, cough, and chest pain]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.","definition_or_measurement_approach":"Time from randomization to first deterioration from baseline in specified pulmonary symptoms reaching a meaningful change threshold."}
  • {"endpoint_text":"- Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.","definition_or_measurement_approach":"Time from randomization to deterioration in PROMIS Physical Function short form 8c reaching a meaningful change threshold."}
  • {"endpoint_text":"- Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.","definition_or_measurement_approach":"Time from randomization to deterioration in Global Health Status/Quality of Life via EORTC IL172 reaching a meaningful change threshold."}
  • {"endpoint_text":"- Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma.","definition_or_measurement_approach":"Pharmacokinetic measurements of plasma concentrations of Dato-DXd, total anti-TROP2 antibody and DXd."}
  • {"endpoint_text":"- Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers).","definition_or_measurement_approach":"Immunogenicity assessment: presence and titer of anti-drug antibodies (ADA) for Dato-DXd (positive/negative, titers)."}

Recruitment

Planned Sample Size
544
Recruitment Window Months
45
Consent Approach
Informed consent is obtained via country-specific Informed Consent Forms (L1 Country ICF Main and supporting L1 documents). Multiple language versions and country-specific supplementary ICFs are provided (examples in the record: English, Greek, German, Dutch, French, Italian, Polish, Spanish). Optional/ancillary consent forms (e.g., genetic research, future research, pregnant partner) are provided as separate L1 documents. No specific assent process for minors is described in the CTIS record.

Methods

  • Site-based recruitment using country-specific recruitment materials (posters, brochures) — K2 recruitment brochures and K2 recruitment posters listed per country.
  • Physician referral / 'Dear Colleague' letters to referring clinicians (country-specific K2 referral letters present in documents).
  • Country-specific recruitment procedure and informed consent processes documented (K1 Recruitment and Informed Consent Procedure documents per country).
  • Patient information guides and subject materials (L2 subject materials, PROMIS/EORTC questionnaires) provided to potential participants.

Geography

Total Number Of Sites
78
Total Number Of Participants
200

Belgium

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
489
Number Of Sites
10
Number Of Participants
25

Sites

Site Name
Antwerp University Hospital
Department Name
0503: Thoraxoncologie
Principal Investigator Name
Reinier Wener
Principal Investigator Email
reinier.wener@uza.be
Contact Person Name
Reinier Wener
Contact Person Email
reinier.wener@uza.be
Site Name
CHU Helora
Department Name
0506
Principal Investigator Name
Gaétan Catala
Principal Investigator Email
gaetan.catala@jolimont.be
Contact Person Name
Gaétan Catala
Contact Person Email
gaetan.catala@jolimont.be
Site Name
Universitair Ziekenhuis Gent
Department Name
0505: Pneumologie
Principal Investigator Name
Veerle Surmont
Principal Investigator Email
veerle.surmont@uzgent.be
Contact Person Name
Veerle Surmont
Contact Person Email
veerle.surmont@uzgent.be
Site Name
Grand Hopital De Charleroi
Department Name
0502
Principal Investigator Name
Benoit Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
Az Maria Middelares Gent
Department Name
0501: Pneumologie
Principal Investigator Name
Paul Germonpré
Principal Investigator Email
paul.germonpre@azmmsj.be
Contact Person Name
Paul Germonpré
Contact Person Email
paul.germonpre@azmmsj.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
0509
Principal Investigator Name
Jean-Charles Goeminne
Contact Person Name
Jean-Charles Goeminne
Site Name
Jessa Ziekenhuis
Department Name
0504: Pneumologie - Thoracale Oncologie
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
UZ Brussel
Department Name
0507: Oncologisch Centrum
Principal Investigator Name
Lore Decoster
Principal Investigator Email
lore.decoster@uzbrussel.be
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
Site Name
UZ Leuven
Department Name
0510: Pneumologie
Principal Investigator Name
Christophe Dooms
Principal Investigator Email
christophe.dooms@uzleuven.be
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
0508
Principal Investigator Name
Ingel Demedts
Principal Investigator Email
ingel.demedts@azdelta.be
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be

France

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
508
Number Of Sites
14
Number Of Participants
33

Sites

Site Name
Direction Centrale Du Service De Sante Des Armees
Department Name
2302: Respiratory
Principal Investigator Name
Olivier Bylicki
Principal Investigator Email
olivier.bylicky@intradef.gouv.fr
Contact Person Name
Olivier Bylicki
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
2309: Service de Pneumologie
Principal Investigator Name
Marie Capucine Willemin
Principal Investigator Email
mariecapucine.willemin@chu-angers.fr
Contact Person Name
Marie Capucine Willemin
Site Name
Institut Bergonie
Department Name
2301: Medical Oncology
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
Centre Hospitalier Universitaire De Toulouse
Department Name
2311: 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
Centre Hospitalier Regional Universitaire De Tours
Department Name
2314: Pneumology Department - Hôpital Bretonneau
Principal Investigator Name
Eric Pichon
Principal Investigator Email
e.pichon@chu-tours.fr
Contact Person Name
Eric Pichon
Contact Person Email
e.pichon@chu-tours.fr
Site Name
Hopital Cardiologique
Department Name
2307: Pulmonary - Thoracic Oncology
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 Francois Baclesse
Department Name
2313: Department of pneumology
Principal Investigator Name
Hubert Curcio
Principal Investigator Email
h.curcio@baclesse.unicancer.fr
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
2305: Departement de Medecine oncologique - Oncologie Thoracique
Principal Investigator Name
David Planchard
Principal Investigator Email
David.Planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Centre Hospitalier D Avignon
Department Name
2303: Médecine Interne Onco-Hématolo
Principal Investigator Name
Nicolas Cloarec
Principal Investigator Email
cloarec.nicolas@ch-avignon.fr
Contact Person Name
Nicolas Cloarec
Contact Person Email
cloarec.nicolas@ch-avignon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
2306: respiratory desease
Principal Investigator Name
Remi Veillon
Principal Investigator Email
remi.veillon@chu-bordeaux.fr
Contact Person Name
Remi Veillon
Contact Person Email
remi.veillon@chu-bordeaux.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
2308: Thoracic oncology
Principal Investigator Name
Nadia Guezour
Principal Investigator Email
nguezour@ghpsj.fr
Contact Person Name
Nadia Guezour
Contact Person Email
nguezour@ghpsj.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
2315: Chest Department
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
Institut Regional Du Cancer De Montpellier
Department Name
2304: Oncologie Medicale
Principal Investigator Name
Quentin THOMAS
Principal Investigator Email
quentin.thomas@icm.unicancer.fr
Contact Person Name
Quentin THOMAS
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
2312: Oncology Medical Department - Oncology Thoracic Unit
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

Germany

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
489
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
Justus-Liebig-Universitaet Giessen
Department Name
2614: Medizinische Klinik IV Organonkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
Thomas.Wehler@innere.med.uni-giessen.de
Contact Person Name
Thomas Wehler
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
2611: Klinikum Emil von Behring
Principal Investigator Name
Daniel Misch
Principal Investigator Email
daniel.misch@helios-kliniken.de
Contact Person Name
Daniel Misch
Site Name
Universitaetsklinikum Essen AöR
Department Name
2609: Oncology
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
Asklepios Kliniken Hamburg GmbH
Department Name
2605: Klinik für Pneumologie
Principal Investigator Name
Claas Wesseler
Principal Investigator Email
c.wesseler@asklepios.com
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
2613: Hämatologie,Onkologie und Palliativmedizin
Principal Investigator Name
Maike de Wit
Principal Investigator Email
maike.dewit@vivantes.de
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
2603: Onkologie
Principal Investigator Name
Martin Reck
Principal Investigator Email
m.reck@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
Franziskus Hospital Harderberg
Department Name
2602: Internistische Onkologie und Hämatologie
Principal Investigator Name
Petra Hoffknecht
Principal Investigator Email
petra.hoffknecht@niels-stensen-kliniken.de
Contact Person Name
Petra Hoffknecht
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
2612: Standort Fachklinik Löwenstein, Med.Klinik II Onkologie mit Palliativmedizin
Principal Investigator Name
Jonas Kuon
Principal Investigator Email
jonas.kuon@slk-kliniken.de
Contact Person Name
Jonas Kuon
Contact Person Email
jonas.kuon@slk-kliniken.de
Site Name
Studiengesellschaft Hämato-Onkologie Hamburg
Department Name
2604: Prof. Laack und Partner
Principal Investigator Name
Eckart Laack
Principal Investigator Email
e.laack@haemato-onkologie-hh.de
Contact Person Name
Eckart Laack
Site Name
Klinikum Nuernberg
Department Name
2607: Pneumologie
Principal Investigator Name
Wolfgang Brückl
Principal Investigator Email
wolfgang.brueckl@klinikum-nuernberg.de
Contact Person Name
Wolfgang Brückl
Site Name
Pius-Hospital Oldenburg
Department Name
2608: Internistische Onkologie
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger

Italy

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
490
Number Of Sites
12
Number Of Participants
46

Sites

Site Name
Istituto Oncologico Veneto
Department Name
#4105;UOC Oncologia Medica 2
Principal Investigator Name
Laura Bonanno
Principal Investigator Email
laura.bonanno@iov.veneto.it
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
#4111;Oncologia Medica
Principal Investigator Name
Carlo Carnaghi
Principal Investigator Email
carlo.carnaghi@ccocatania.it
Contact Person Name
Carlo Carnaghi
Contact Person Email
carlo.carnaghi@ccocatania.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
#4112; UOC Oncologia
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
Hospital Santa Maria Della Misericordia
Department Name
#4110;Oncologia Medica
Principal Investigator Name
Giulio Metro
Principal Investigator Email
giulio.metro@ospedale.perugia.it
Contact Person Name
Giulio Metro
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
#4104;UOC Oncologia Medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
marcello.tiseo@unipr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
marcello.tiseo@unipr.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
#4108;S.C. Oncologia Medica Toraco-Polmonare
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
#4102;SSD Oncologia Polmonare
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
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
#4101;U.O.C. Centro di ricerca di Fase I
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
#4106;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 Europeo Di Oncologia S.r.l.
Department Name
#4109;Oncologia Toracica
Principal Investigator Name
Antonio Passaro
Principal Investigator Email
antonio.passaro@ieo.it
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
#4107;SSD Oncologia Medica per la Patologia Toracica
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
#4103;Oncologia Medica ed Ematologia
Principal Investigator Name
Luca Toschi
Principal Investigator Email
luca.toschi@humanitas.it
Contact Person Name
Luca Toschi
Contact Person Email
luca.toschi@humanitas.it

Poland

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
488
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
#5703 Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
k.stencel@post.pl
Contact Person Name
Katarzyna Stencel
Contact Person Email
k.stencel@post.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
#5704 Pratia Onkologia Katowice
Principal Investigator Name
Agata Kachel - Flis
Principal Investigator Email
agata.kachel-flis@pratia.com
Contact Person Name
Agata Kachel - Flis
Contact Person Email
agata.kachel-flis@pratia.com
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
#5705 Oddzial Onkologii z Pododdzialem Chemioterapii
Principal Investigator Name
Jarosław Kolb - Sielecki
Principal Investigator Email
j.kolbsielecki@gmail.com
Contact Person Name
Jarosław Kolb - Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Pratia S.A.
Department Name
#5702 Pratia MCM Krakow
Principal Investigator Name
Anna Drosik-Kwasniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.pl
Contact Person Name
Anna Drosik-Kwasniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl
Site Name
Instytut Msf Sp. z o.o.
Department Name
#5701 Instytut Medyczny Santa Familia
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl

Greece

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
497
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Athens Medical Center S.A.
Department Name
3001: 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
Metropolitan Hospital
Department Name
3008: 4th Oncology Department
Principal Investigator Name
Helena Linardou
Principal Investigator Email
elinardou@otenet.gr
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@otenet.gr
Site Name
Henry Dunant Hospital Center
Department Name
3002: 4th Oncology Department
Principal Investigator Name
Giannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Giannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
3003: Oncology department, Section Z3
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
3010: University Pulmonary Department
Principal Investigator Name
Dionisios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionisios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
3005: Molecular Medicine Clinic/Clinical Trials
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3004: Oncology unit, 3rd Department of 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

Spain

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
494
Number Of Sites
19
Number Of Participants
46

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
7008: Oncología Médica
Principal Investigator Name
Marta López-Brea Piqueres
Principal Investigator Email
marta.lopezbrea@gmail.com
Contact Person Name
Marta López-Brea Piqueres
Contact Person Email
marta.lopezbrea@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
7016: Oncología Médica
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
Hospital Quironsalud Malaga
Department Name
7009: Servicio de Oncologia Medica
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuel.cobo.co@quironsalud.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuel.cobo.co@quironsalud.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
7018: Oncología
Principal Investigator Name
Miguel Fernandez De Sanmamed Gutierrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
7011: Servicio de Oncologia Medica
Principal Investigator Name
Jose Fuentes Pradera
Principal Investigator Email
fuentespradera@hotmail.com
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
7005: Oncología Médica
Principal Investigator Name
Maria Rosario Garcia Campelo
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Universitario De Cruces
Department Name
7013: Oncología Médica
Principal Investigator Name
Eider Azkona Uribelarrea
Principal Investigator Email
eider.azkonauribelarrea@osakidetza.eus
Contact Person Name
Eider Azkona Uribelarrea
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
7001: Oncología Médica
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario La Paz
Department Name
7015: Oncología Médica
Principal Investigator Name
Javier de Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier de Castro Carpeño
Site Name
University Hospital Son Espases
Department Name
7012: Oncología
Principal Investigator Name
Aitor Azkarate Martinez
Principal Investigator Email
aitor.azkarate@ssib.es
Contact Person Name
Aitor Azkarate Martinez
Contact Person Email
aitor.azkarate@ssib.es
Site Name
Institut Catala D'oncologia
Department Name
7002: Oncologia
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
7006: Oncologia Médica y Hematologia
Principal Investigator Name
Paloma Martin Martorell
Principal Investigator Email
paloma_martin@comv.es
Contact Person Name
Paloma Martin Martorell
Contact Person Email
paloma_martin@comv.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
7010:Oncología
Principal Investigator Name
Mariano Provencio Pulla
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Del Mar
Department Name
7003: Oncología Médica
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
Complexo Hospitalario Universitario De Santiago
Department Name
7004: Servicio de Oncologia Medica
Principal Investigator Name
Jorge Jose Garcia Gonzalez
Principal Investigator Email
jorge.jose.garcia.gonzalez@sergas.es
Contact Person Name
Jorge Jose Garcia Gonzalez
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
7014: Oncología
Principal Investigator Name
Silverio Ros Martínez
Principal Investigator Email
silverio.ros@carm.es
Contact Person Name
Silverio Ros Martínez
Contact Person Email
silverio.ros@carm.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
7017: Oncología
Principal Investigator Name
Rafael López Castro
Principal Investigator Email
rlopezc@saludcastillayleon.es
Contact Person Name
Rafael López Castro
Contact Person Email
rlopezc@saludcastillayleon.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
7007: Oncología
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
7019: Oncología
Principal Investigator Name
Miguel Fernandez De Sanmamed Gutierrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed Gutierrez
Contact Person Email
msanmamed@unav.es

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Sponsor duties codes: 1,10,11,12,13,14,2,4,5,6,7,8
Name
Excelya Greece CRO Single Member S.A.
Responsibilities
Sponsor duties codes: 1

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,14,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Sponsor duties codes: 1","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Investigational Product Name
TAGRISSO 40 mg film-coated tablets
Active Substance
OSIMERTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation: EU/1/16/1086/003
Starting Dose
40 mg
Dose Levels
40 mg
Investigational Product Name
TAGRISSO 80 mg film-coated tablets
Active Substance
OSIMERTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation: EU/1/16/1086/004
Starting Dose
80 mg
Dose Levels
80 mg
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Combination Treatment
Yes

Related trials

Other published trials that may interest you.