Clinical trial • Phase III • Oncology

Durvalumab for Non-small cell lung cancer (advanced/metastatic) | Non-small cell lung cancer (locally advanced, unresectable; Stage III) | Small-cell lung cancer (extensive disease, Stage IV) | Urothelial carcinoma of the urinary tract (post-chemotherapy)

Phase III trial of Durvalumab for Non-small cell lung cancer (advanced/metastatic) | Non-small cell lung cancer (locally advanced, unresectable; Stage III…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (advanced/metastatic) | Non-small cell lung cancer (locally advanced, unresectable; Stage III) | Small-cell lung cancer (extensive disease, Stage IV) | Urothelial carcinoma of the urinary tract (post-chemotherapy)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
25-01-2024
First CTIS Authorization Date
10-04-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Poland, Czechia, Germany and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
142
Trial Duration For Participant
728

Eligibility

Recruits 142 Vulnerable population selected. Informed consent must be provided: "Provision of signed and dated, written ICF". Country-specific subject information and informed consent forms are available in multiple languages (country ICF documents listed)..

Pregnancy Exclusion
Additional exclusion criteria for the ROSY-D sub-study: Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
Vulnerable Population
Vulnerable population selected. Informed consent must be provided: "Provision of signed and dated, written ICF". Country-specific subject information and informed consent forms are available in multiple languages (country ICF documents listed).

Inclusion criteria

  • {"criterion_text":"- Provision of signed and dated, written ICF"}
  • {"criterion_text":"- Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol"}
  • {"criterion_text":"- Patient can receive durvalumab as a fixed dose of 1500 mg Q4W at study entry."}

Exclusion criteria

  • {"criterion_text":"- Core Protocol exclusion criteria: Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study"}
  • {"criterion_text":"- Core Protocol exclusion criteria: Currently receiving treatment with any prohibited medication(s)."}
  • {"criterion_text":"- Core Protocol exclusion criteria: Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study."}
  • {"criterion_text":"- Core Protocol exclusion criteria: Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient’s condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, Response Evaluation Criteria in Solid Tumours] progression or clinical progression)."}
  • {"criterion_text":"- Core Protocol exclusion criteria: Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation."}
  • {"criterion_text":"- Additional exclusion criteria for the ROSY-D sub-study: Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies)."}
  • {"criterion_text":"- Additional exclusion criteria for the ROSY-D sub-study: Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy."}
  • {"criterion_text":"- Additional exclusion criteria for the ROSY-D sub-study: Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- SAEs reported until 90 days after the last dose of study treatment.","definition_or_measurement_approach":"Serious adverse events (SAEs) reported and collected up to 90 days after the participant's last dose of study treatment."}

Recruitment

Planned Sample Size
142
Recruitment Window Months
48
Consent Approach
Signed and dated written informed consent required from participants ('Provision of signed and dated, written ICF'). Country-specific ICFs and participant information documents are provided in multiple languages; contact for study information: Clinical Study Information Center (information.centre@astrazeneca.com).

Geography

Total Number Of Sites
56
Total Number Of Participants
87

Poland

Earliest CTIS Part Ii Submission Date
15-02-2024
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
432
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Zachodniopomorskie Centrum Onkologii
Department Name
5705: Osrodek Badan Klinicznych
Principal Investigator Name
Katarzyna Hetman
Principal Investigator Email
Kk197@wp.pl
Contact Person Name
Katarzyna Hetman
Contact Person Email
Kk197@wp.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
5701: Zaklad Teleradioterapii
Principal Investigator Name
Jacek Fijuth
Principal Investigator Email
jacek.f@poczta.onet.pl
Contact Person Name
Jacek Fijuth
Contact Person Email
jacek.f@poczta.onet.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
5702: Oddzial Onkologii Klinicznej im. dr E. Pileckiej z Pododdzialem Chemioterapii Dziennej
Principal Investigator Name
Krystyna Ostrowska-Cichocka
Principal Investigator Email
krysiaost@poczta.onet.pl
Contact Person Name
Krystyna Ostrowska-Cichocka
Contact Person Email
krysiaost@poczta.onet.pl
Site Name
Instytut Msf Sp. z o.o.
Department Name
5703: Oncology
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Nu Med Grupa S.A.
Department Name
5706: Centrum Radioterapii i Onkologii
Principal Investigator Name
Barbara Szostakiewicz
Principal Investigator Email
barbara.szostakiewicz@nu-med.pl
Contact Person Name
Barbara Szostakiewicz
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
5708: Klinika Nowotworow Pluca i Klatki Piersiowej
Principal Investigator Name
Dariusz kowalski
Principal Investigator Email
dariusz.kowalski@pib-nio.pl
Contact Person Name
Dariusz kowalski
Contact Person Email
dariusz.kowalski@pib-nio.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
5707: Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
5704: Oddzial Onkologii z Pododdzialem Chemioterapii
Principal Investigator Name
Andrzej Kazarnowicz
Principal Investigator Email
andrzej_kazarnowicz@wp.pl
Contact Person Name
Andrzej Kazarnowicz
Contact Person Email
andrzej_kazarnowicz@wp.pl
Site Name
Wojewodzki Szpital Zespolony W Elblagu SPZOZ
Department Name
5706: Oddzial Onkologiczny z Poddodzialem Chemioterapii, Apteka
Principal Investigator Name
Barbara Szostakiewicz
Principal Investigator Email
barbara.szostakiewicz@nu-med.pl
Contact Person Name
Barbara Szostakiewicz

Czechia

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
17-04-2025
Processing Time Days
427
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
University Hospital Olomouc
Department Name
1901: Onkologicka klinika
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Germany

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
23-04-2025
Processing Time Days
433
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitaet Muenster
Department Name
2601: Klinik fuer Urologie und Kinderurologie
Principal Investigator Name
Martin Boegemann
Principal Investigator Email
martin.boegemann@ukmuenster.de
Contact Person Name
Martin Boegemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Onkodok GmbH
Department Name
2602
Principal Investigator Name
Philipp Schütt
Principal Investigator Email
philipp.schuett@uni-due.de
Contact Person Name
Philipp Schütt
Contact Person Email
philipp.schuett@uni-due.de
Site Name
Pius-Hospital Oldenburg
Department Name
2603: Oncology
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger

Greece

Earliest CTIS Part Ii Submission Date
20-03-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
155
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
3001: Department of Medical Oncology
Principal Investigator Name
Eleni Res
Principal Investigator Email
nellieres@yahoo.gr
Contact Person Name
Eleni Res
Contact Person Email
nellieres@yahoo.gr

Romania

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
432
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Sigmedical Services S.R.L.
Department Name
6101: Oncology
Principal Investigator Name
Doina Ganea
Principal Investigator Email
motan_doina@yahoo.com
Contact Person Name
Doina Ganea
Contact Person Email
motan_doina@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
21-04-2025
Processing Time Days
431
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
7005: Oncología Médica
Principal Investigator Name
Joaquim Bosch Barrera
Principal Investigator Email
jbosch@iconcologia.net
Contact Person Name
Joaquim Bosch Barrera
Contact Person Email
jbosch@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
7002: 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
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
Department Name
7008: Departamento de Oncologia
Principal Investigator Name
Urbano Anido Herránz
Principal Investigator Email
urbano.anido.herranz@sergas.es
Contact Person Name
Urbano Anido Herránz
Contact Person Email
urbano.anido.herranz@sergas.es
Site Name
Hospital Costa Del Sol
Department Name
7001: Oncología Médica
Principal Investigator Name
Victor Navarro Perez
Principal Investigator Email
vnavarroonco@gmail.com
Contact Person Name
Victor Navarro Perez
Contact Person Email
vnavarroonco@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
7004: Oncología Médica
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 La Paz
Department Name
7003: 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
Hospital De La Santa Creu I Sant Pau
Department Name
7006: Oncología Médica
Principal Investigator Name
Andrés Barba Joaquín
Principal Investigator Email
abarba@santpau.cat
Contact Person Name
Andrés Barba Joaquín
Contact Person Email
abarba@santpau.cat
Site Name
Hospital Universitari De Girona Doctor Josep Trueta (additional listed site)
Department Name
7005: Oncología Médica

Hungary

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
432
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
3301: Pulmonológiai Osztál
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
Clinic Of Pulmonology Semmelweis University
Department Name
3302: Pulmonológiai Klinika
Principal Investigator Name
György LOSONCZY
Principal Investigator Email
losonczy.gyorgy@med.semmelweis-univ.hu
Contact Person Name
György LOSONCZY
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
3303: IV.Tüdőgyógyászati osztály
Principal Investigator Name
Krisztina BOGOS
Principal Investigator Email
bogos@koranyi.hu
Contact Person Name
Krisztina BOGOS
Contact Person Email
bogos@koranyi.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
3304: Pulmonológiai osztály
Principal Investigator Name
Zsuzsanna SZALAI
Principal Investigator Email
clinstudy@gmail.com
Contact Person Name
Zsuzsanna SZALAI
Contact Person Email
clinstudy@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
17-04-2025
Processing Time Days
168
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Grand Hopital De Charleroi
Department Name
503: Oncology
Principal Investigator Name
Benoit Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be

Bulgaria

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
438
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
MBAL Serdika Ltd.
Department Name
0902: Second Department of Medical Oncology
Principal Investigator Name
Krassimir Koynov
Principal Investigator Email
Kdkoynov@Yahoo.Co.Uk
Contact Person Name
Krassimir Koynov
Contact Person Email
Kdkoynov@Yahoo.Co.Uk
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
0901: Medical Oncology Department
Principal Investigator Name
Bozhil Robev
Principal Investigator Email
bostro@abv.bg
Contact Person Name
Bozhil Robev
Contact Person Email
bostro@abv.bg

Italy

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
09-09-2025
Processing Time Days
572
Number Of Sites
12
Number Of Participants
24

Sites

Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
4104: UOS Oncologia Medica
Principal Investigator Name
Giuseppa Scandurra
Principal Investigator Email
giusy.scandurra@gmail.com
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
4101: Oncologia Medica
Principal Investigator Name
Antonietta D’Alessio
Principal Investigator Email
adalessio@scamilloforlanini.rm.it
Contact Person Name
Antonietta D’Alessio
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
4117: Struttura Complessa Oncologia Medica 1
Principal Investigator Name
Filippo De Braud
Principal Investigator Email
debraud_studiclinici@istitutotumori.mi.it
Contact Person Name
Filippo De Braud
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
4108: UOC di Oncologia
Principal Investigator Name
Gianluca Masi
Principal Investigator Email
gianluca.masi@unipi.it
Contact Person Name
Gianluca Masi
Contact Person Email
gianluca.masi@unipi.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
4106: U.O. Oncologia Medica
Principal Investigator Name
Giuseppe Schepisi
Principal Investigator Email
giuseppe.schepisi@irst.emr.it
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it
Site Name
Azienda USL Toscana Sud Est
Department Name
4103: U.O.C. Oncologia Medica
Principal Investigator Name
Alketa Hamzaj
Principal Investigator Email
alketa.hamzaj@uslsudest.toscana.it
Contact Person Name
Alketa Hamzaj
Site Name
European Institute Of Oncology S.r.l.
Department Name
4105: Oncologia Medica Urogenitale e Cervico Facciale
Principal Investigator Name
Franco Nolè
Principal Investigator Email
franco.nole@ieo.it
Contact Person Name
Franco Nolè
Contact Person Email
franco.nole@ieo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
4115: 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
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
4109: Oncologia Medica
Principal Investigator Name
Giuseppe Tonini
Principal Investigator Email
g.tonini@policlinicocampus.it
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@policlinicocampus.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
4113: SC Radioterapia
Principal Investigator Name
Alessio Bruni
Principal Investigator Email
bruni.alessio@aou.mo.it
Contact Person Name
Alessio Bruni
Contact Person Email
bruni.alessio@aou.mo.it
Site Name
Istituto Oncologico Veneto
Department Name
4102: UOC Oncologia Medica 1
Principal Investigator Name
Marco Maruzzo
Principal Investigator Email
marco.maruzzo@iov.veneto.it
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro (additional listed site)

France

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
592
Number Of Sites
14
Number Of Participants
23

Sites

Site Name
CHU De Rouen
Department Name
2301: Urology
Principal Investigator Name
Christian Pfister
Principal Investigator Email
christian.pfister@chu-rouen.fr
Contact Person Name
Christian Pfister
Contact Person Email
christian.pfister@chu-rouen.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
2312: Oncologie Medicale
Principal Investigator Name
Bérengère Narciso
Principal Investigator Email
berengere.narciso@univ-tours.fr
Contact Person Name
Bérengère Narciso
Site Name
Besancon University Hospital Center
Department Name
2314: Service d'Oncologie Médicale
Principal Investigator Name
Tristan MAURINA
Principal Investigator Email
t1maurina@chu-besancon.fr
Contact Person Name
Tristan MAURINA
Contact Person Email
t1maurina@chu-besancon.fr
Site Name
Institut Bergonie
Department Name
2311: Oncologie Médicale et Pédiatrique
Principal Investigator Name
Guilhem Roubaud
Principal Investigator Email
g.roubaud@bordeaux.unicancer.fr
Contact Person Name
Guilhem Roubaud
Site Name
Institut Gustave Roussy
Department Name
2309: Medical Oncology (Thoracic Unit)
Principal Investigator Name
Yohann Loriot
Principal Investigator Email
yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohann Loriot
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Centre Leon Berard
Department Name
2310: département d'oncologie médica
Principal Investigator Name
Aude Fléchon
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude Fléchon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
2321: medical oncology
Principal Investigator Name
Thibault De La Motte Rouge
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault De La Motte Rouge
Site Name
Centre Hospitalier Regional De Marseille
Department Name
2307: Medical oncology
Principal Investigator Name
Jean Laurent Deville
Principal Investigator Email
jean-laurent.deville@ap-hm.fr
Contact Person Name
Jean Laurent Deville
Contact Person Email
jean-laurent.deville@ap-hm.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
2305: Oncologie Médicale
Principal Investigator Name
Diego Tosi
Principal Investigator Email
diego.tosi@icm.unicancer.fr
Contact Person Name
Diego Tosi
Contact Person Email
diego.tosi@icm.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
2308: Département d'oncologie
Principal Investigator Name
Frédéric Rolland
Principal Investigator Email
frederic.rolland@ico.unicancer.fr
Contact Person Name
Frédéric Rolland
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
2306: Oncology
Principal Investigator Name
Philippe BARTHELEMY
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe BARTHELEMY
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
2320: Service d´Oncologie Médicale
Principal Investigator Name
Carlos-Alberto Gomez-Roca
Principal Investigator Email
GomezRoca.Carlos@iuct-oncopole.fr
Contact Person Name
Carlos-Alberto Gomez-Roca
Site Name
Centr Georges Francois Leclerc
Department Name
2316: Service d'oncologie medicale
Principal Investigator Name
Isabelle Desmoulins
Principal Investigator Email
idesmoulins@cgfl.fr
Contact Person Name
Isabelle Desmoulins
Contact Person Email
idesmoulins@cgfl.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
2303: Oncologie Médicale
Principal Investigator Name
Benjamin Auberger
Principal Investigator Email
benjamin.auberger@chu-brest.fr
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr

Sponsor

Primary sponsor

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

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
Study start-up; Site contracting
Name
Parexel International (IRL) Limited
Responsibilities
Multiple sponsor duties including site contracting and other trial operational activities (codes listed: 1,10,11,12,15,5,6)

Third parties

  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"codes: 1; 15 (Study start-up; Site contracting)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"codes: 1,10,11,12,15 (Site contracting),5,6","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
Durvalumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous infusion
Authorisation Status
Authorised - EU marketing authorisation EU/1/18/1322/001
Starting Dose
1500 mg fixed dose (Q4W); weight-based 20 mg/kg Q4W if weight ≤ 30 kg until >30 kg
Dose Levels
1500 mg fixed dose; alternative weight-based 20 mg/kg for patients ≤ 30 kg
Frequency
Every 4 weeks (Q4W)
Maximum Dose
1500 mg
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
Mycophenolate mofetil
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Commercially available (sourced locally; specific national marketing authorisation applies)
Investigational Product Name
INFLIXIMAB
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous infusion
Authorisation Status
Commercially available (sourced locally; specific national marketing authorisation applies)

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