Clinical trial • Phase III • Oncology

durvalumab for Non-small cell lung cancer (stage I/II) | EGFR-mutant non-small cell lung cancer

Phase III trial of durvalumab for Non-small cell lung cancer (stage I/II) | EGFR-mutant non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (stage I/II) | EGFR-mutant non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
25-04-2024
First CTIS Authorization Date
06-06-2024

Trial design

Randomised, open-label, main cohort comparator: sbrt + durvalumab versus sbrt + placebo (glucose infusion). osimertinib cohort: sbrt followed by osimertinib (single-arm). doses/schedules not specified in part i product summary here.-controlled Phase III trial in Germany, Netherlands, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Main cohort comparator: SBRT + Durvalumab versus SBRT + Placebo (glucose infusion). Osimertinib cohort: SBRT followed by osimertinib (single-arm). Doses/schedules not specified in Part I product summary here.
Biomarker Stratified
True, EGFR mutation (Ex19del, L858R)
Target Sample Size
542
Trial Duration For Participant
1460

Eligibility

Recruits 542 No vulnerable populations selected. Age eligibility requires participants to be ≥18 years. Informed consent requirement: "(Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses." Consent is provided by adult participants; assent/parental consent not applicable..

Vulnerable Population
No vulnerable populations selected. Age eligibility requires participants to be ≥18 years. Informed consent requirement: "(Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses." Consent is provided by adult participants; assent/parental consent not applicable.

Inclusion criteria

  • {"criterion_text":"- (Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses\n- (Main cohort (durvalumab) specific) Life expectancy of at least 12 weeks\n- (Main cohort (durvalumab) specific) Body weight >30 kg\n- (Main cohort (durvalumab) specific) Adequate organ and marrow function required\n- (Main cohort (durvalumab) specific) Pulmonary Function Testing within 16 weeks of randomization\n- (Osimertinib cohort specific) Confirmation by local laboratory that the tumor harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)\n- (Osimertinib cohort specific) Adequate bone marrow reserve or organ function required\n- (Applicable to both cohorts) Age ≥18 years\n- (Applicable to both cohorts) Histologically or cytologically documented Stage I to II NSCLC, with clinical T1 to T3N0M0 Stage I/II disease and planned to receive definitive treatment with SBRT (Stereotactic Body Radiation Therapy). Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy\n- (Applicable to both cohorts) Planned SoC SBRT as definitive treatment\n- (Applicable to both cohorts) World Health Organization (WHO)/ECOG PS of 0, 1, or 2\n- (Applicable to both cohorts) Patients with central or peripheral lesions are eligible\n- (Applicable to both cohorts) Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions\n- (Applicable to both cohorts) Staging studies must be done during screening (PET-CT within 10 weeks)\n- (Applicable to both cohorts) Submission of available tumor tissue or cell block samples from FNA"}

Exclusion criteria

  • {"criterion_text":"- (Applicable to both cohorts) Mixed small cell and non-small cell cancer\n- (Osimertinib cohort specific) Patients with known or increased risk factor for QTc prolongation\n- (Osimertinib cohort specific) Treatment with any of the following: Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation; Prior treatment with neoadjuvant or adjuvant EGFR TKI; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib\n- (Osimertinib cohort specific) Any of the following cardiac criteria: Mean resting corrected QT interval >470 msec, obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval; Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD\n- (Applicable to both cohorts) History of another primary malignancy with exceptions\n- (Main cohort specific) Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort\n- (Main cohort specific) History of allogeneic organ transplantation\n- (Main cohort specific) History of active primary immunodeficiency or autoimmune disorders\n- (Main cohort specific) History of non-infectious pneumonitis requiring steroids\n- (Main cohort specific) Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus\n- (Main cohort specific) Prior exposure to immune-mediate therapy\n- (Osimertinib cohort specific) Patients currently receiving potent inducers of CYP3A4"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR) according to imaging/standard tumour assessment (RECIST-based assessments as applicable)."}
  • {"endpoint_text":"- Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1","definition_or_measurement_approach":"4-year progression-free survival assessed by Independent Central Review (ICR) using RECIST 1.1 criteria."}

Secondary endpoints

  • {"endpoint_text":"- Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings","definition_or_measurement_approach":"Endpoints include PFS, OS, PFS24, TTP, TTDM assessed by BICR per RECIST 1.1; PFS2 by local assessment; pharmacokinetics (serum durvalumab concentrations); immunogenicity (ADA presence); HRQoL by EORTC QLQ-C30; safety via AEs (CTCAE), exams, vitals, ECGs, labs."}
  • {"endpoint_text":"- Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2","definition_or_measurement_approach":"Safety endpoints graded by CTCAE v5; labs and clinical evaluations as listed; cardiac monitoring including ECG parameters and LVEF; functional status (WHO/ECOG); efficacy endpoints PFS (RECIST 1.1), OS, site(s) of progression, time to CNS progression, TTP, and PFS2."}

Recruitment

Planned Sample Size
542
Recruitment Window Months
45
Consent Approach
Informed consent: "(Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses." Participants must be ≥18 years and provide written consent. Site-specific ICF/SIS documents provided (multiple language versions are included in the submission e.g., English, French, Spanish, Dutch, Polish, Greek, Italian as per submitted ICF/SIS documents).

Geography

Total Number Of Sites
58
Total Number Of Participants
148

Germany

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
16
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Strahlentherapie
Principal Investigator Name
Felix Steger
Principal Investigator Email
Felix.Steger@klinik.uni-regensburg.de
Contact Person Name
Felix Steger
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Principal Investigator Name
Wolfgang Schütte
Principal Investigator Email
wolfgang.schuette@martha-maria.de
Contact Person Name
Wolfgang Schütte
Site Name
Barmherzige Brueder Trier gGmbH
Principal Investigator Name
Christian Kaes
Principal Investigator Email
c.kaes@bbtgruppe.de
Contact Person Name
Christian Kaes
Contact Person Email
c.kaes@bbtgruppe.de
Site Name
Thoraxklinik Heidelberg gGmbH
Principal Investigator Name
Farastuk Bozorgmehr
Principal Investigator Email
Farastuk.Bozorgmehr@med.uni-heidelberg.de
Contact Person Name
Farastuk Bozorgmehr
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Principal Investigator Name
Esther Troost
Principal Investigator Email
esther.troost@uniklinikum-dresden.de
Contact Person Name
Esther Troost
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Strahlentherapie und Radioonkologie
Principal Investigator Name
Rami El Shafie
Contact Person Name
Rami El Shafie
Site Name
Klinikum Region Hannover GmbH
Department Name
Klinik für Pneumologie, Intensiv- und Schlafmedizin
Principal Investigator Name
Thomas Fühner
Principal Investigator Email
thomas.fuehner@krh.de
Contact Person Name
Thomas Fühner
Contact Person Email
thomas.fuehner@krh.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Innere Medizin V - Pneumologie, Allergologie, Beatmungs- und Umweltmedizin
Principal Investigator Name
Jan Stratmann
Principal Investigator Email
jan.stratmann@uks.eu
Contact Person Name
Jan Stratmann
Contact Person Email
jan.stratmann@uks.eu

Netherlands

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
06-06-2024
Processing Time Days
15
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
Universiteit Maastricht
Department Name
Longziekten
Principal Investigator Name
Lizza Hendriks
Principal Investigator Email
trials.longoncologie@mumc.nl
Contact Person Name
Lizza Hendriks
Contact Person Email
trials.longoncologie@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Pulmonary Diseases
Principal Investigator Name
Jeroen Hiltermann
Principal Investigator Email
t.j.n.Hiltermann@umcg.nl
Contact Person Name
Jeroen Hiltermann
Contact Person Email
t.j.n.Hiltermann@umcg.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Longgeneeskunde
Principal Investigator Name
Susan Keizer-van 't Westeinde
Principal Investigator Email
WesteindeS@maasstadziekenhuis.nl
Contact Person Name
Susan Keizer-van 't Westeinde
Site Name
Amsterdam UMC Stichting
Department Name
Pulmonary Diseases
Principal Investigator Name
Sayed Hashemi
Principal Investigator Email
s.hashemi@amsterdamumc.nl
Contact Person Name
Sayed Hashemi
Contact Person Email
s.hashemi@amsterdamumc.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Longgeneeskunde
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
LN.Boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hart en Longen
Principal Investigator Name
Evelien van der Hout
Principal Investigator Email
e.c.vanderhout@umcutrecht.nl
Contact Person Name
Evelien van der Hout
Contact Person Email
e.c.vanderhout@umcutrecht.nl
Site Name
Universitair Medisch Centrum Utrecht (duplicate entry in listing?)
Department Name
Hart en Longen
Principal Investigator Name
Evelien van der Hout
Principal Investigator Email
e.c.vanderhout@umcutrecht.nl
Contact Person Name
Evelien van der Hout
Contact Person Email
e.c.vanderhout@umcutrecht.nl

Italy

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
33
Number Of Sites
8
Number Of Participants
28

Sites

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
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
gianni.luca@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
gianni.luca@hsr.it
Site Name
Careggi University Hospital
Department Name
Cancer Radiotherapy
Principal Investigator Name
Lorenzo Livi
Principal Investigator Email
lorenzo.livi@unifi.it
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Oncology Hematology
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
a.filippi@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
a.filippi@smatteo.pv.it
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
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Cancer Radiotherapy
Principal Investigator Name
Sara Ramella
Principal Investigator Email
s.ramella@unicampus.it
Contact Person Name
Sara Ramella
Contact Person Email
s.ramella@unicampus.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncology
Principal Investigator Name
Armando Santoro
Principal Investigator Email
armando.santoro@cancercenter.humanitas.it
Contact Person Name
Armando Santoro

Spain

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
06-06-2024
Processing Time Days
15
Number Of Sites
12
Number Of Participants
30

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Oncología
Principal Investigator Name
Luis León Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis León Mateos
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Oncología
Principal Investigator Name
Manuel Domine Gomez
Principal Investigator Email
mdomine@fjd.es
Contact Person Name
Manuel Domine Gomez
Contact Person Email
mdomine@fjd.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Oncología
Principal Investigator Name
Maria Amelia Insa Molla
Principal Investigator Email
ameliainsamolla@gmail.com
Contact Person Name
Maria Amelia Insa Molla
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Oncología
Principal Investigator Name
Dolores Isla Casado
Principal Investigator Email
disla@salud.aragon.es
Contact Person Name
Dolores Isla Casado
Contact Person Email
disla@salud.aragon.es
Site Name
Hospital Universitario De Badajoz
Department Name
Servicio de Oncología
Principal Investigator Name
Marta González Cordero
Principal Investigator Email
martagcordero@gmail.com
Contact Person Name
Marta González Cordero
Contact Person Email
martagcordero@gmail.com
Site Name
Hospital Universitario Donostia
Department Name
Servicio de Oncología
Principal Investigator Name
Alfredo Paredes Lario
Principal Investigator Email
ALFREDO.PAREDESLARIO@osakidetza.eus
Contact Person Name
Alfredo Paredes Lario
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Oncología
Principal Investigator Name
Javier De Castro Carpeño
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro Carpeño
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Oncología
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 Universitario 12 De Octubre
Department Name
Servicio de Oncología
Principal Investigator Name
Santiago Ponce Aix
Principal Investigator Email
sponceaix@gmail.com
Contact Person Name
Santiago Ponce Aix
Contact Person Email
sponceaix@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Oncología
Principal Investigator Name
Jose Carlos Benitez Montañez
Principal Investigator Email
Josecarlos.benitez@ibima.eu
Contact Person Name
Jose Carlos Benitez Montañez
Contact Person Email
Josecarlos.benitez@ibima.eu
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncología
Principal Investigator Name
Reyes Bernabe Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncología
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat

Greece

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
61
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine, Oncology Unit
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
Henry Dunant Hospital Center
Department Name
4th Oncology Department
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Metropolitan Hospital
Department Name
4rth Oncology Clinic
Principal Investigator Name
Helena Linardou
Principal Investigator Email
elinardou@otenet.gr
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@otenet.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Principal Investigator Name
Georgios Fountzilas
Principal Investigator Email
fountzil@auth.gr
Contact Person Name
Georgios Fountzilas
Contact Person Email
fountzil@auth.gr

France

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
06-06-2024
Processing Time Days
15
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Institut Gustave Roussy
Department Name
Département de Médecine
Principal Investigator Name
David Planchard
Principal Investigator Email
David.PLANCHARD@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Hopital Prive Clairval
Department Name
Departement de radiothérapie
Principal Investigator Name
Jean-Baptiste Paoli
Principal Investigator Email
jb.paoli@free.fr
Contact Person Name
Jean-Baptiste Paoli
Contact Person Email
jb.paoli@free.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pneumologie
Principal Investigator Name
Julien Mazières
Principal Investigator Email
mazieres.j@chu-toulouse.fr
Contact Person Name
Julien Mazières
Contact Person Email
mazieres.j@chu-toulouse.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie radiothérapie
Principal Investigator Name
Etienne Martin
Principal Investigator Email
EMartin@cgfl.fr
Contact Person Name
Etienne Martin
Contact Person Email
EMartin@cgfl.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Oncologie médicale
Principal Investigator Name
Claude Elkouri
Principal Investigator Email
claude.elkouri@groupeconfluent.fr
Contact Person Name
Claude Elkouri
Site Name
Hospices Civils De Lyon (Pierre Benite)
Department Name
Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique
Principal Investigator Name
Sebastien Couraud
Principal Investigator Email
sebastien.couraud@chu-lyon.fr
Contact Person Name
Sebastien Couraud
Contact Person Email
sebastien.couraud@chu-lyon.fr
Site Name
Hopital De La Croix-Rousse
Department Name
Service de Pneumologie
Principal Investigator Name
René Chumbi-Flores
Principal Investigator Email
washington.chumbi-flores@chu-lyon.fr
Contact Person Name
René Chumbi-Flores
Site Name
Hospices Civils De Lyon (Bron)
Department Name
Service de Pneumologie
Principal Investigator Name
Mickael Duruisseaux
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Mickael Duruisseaux

Belgium

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
16
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Oncologie-hematologie
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
Onze-Lieve-Vrouwziekenhuis
Department Name
Pneumologie-Respiratoire Oncologie
Principal Investigator Name
Piet Vercauter
Principal Investigator Email
piet.vercauter@olvz-aalst.be
Contact Person Name
Piet Vercauter
Contact Person Email
piet.vercauter@olvz-aalst.be
Site Name
Antwerp University Hospital
Department Name
Pneumologie-Respiratoire Oncologie
Principal Investigator Name
Annelies Janssens
Principal Investigator Email
Annelies.Janssens@uza.be
Contact Person Name
Annelies Janssens
Contact Person Email
Annelies.Janssens@uza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Longziekten
Principal Investigator Name
Veerle F. Surmont
Principal Investigator Email
veerle.surmont@uzgent.be
Contact Person Name
Veerle F. Surmont
Contact Person Email
veerle.surmont@uzgent.be
Site Name
UZ Leuven
Department Name
Respiratoire Oncologie
Principal Investigator Name
Christophe Dooms
Principal Investigator Email
christophe.dooms@uzleuven.be
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be

Poland

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
26
Number Of Sites
6
Number Of Participants
28

Sites

Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Łukasz Michalecki
Principal Investigator Email
lukaszmichalecki@gmail.com
Contact Person Name
Łukasz Michalecki
Contact Person Email
lukaszmichalecki@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Rafał Dziadziuszko
Principal Investigator Email
rafald@gumed.edu.pl
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Principal Investigator Name
Jacek Fijuth
Principal Investigator Email
jacekf@kopernik.lodz.pl
Contact Person Name
Jacek Fijuth
Contact Person Email
jacekf@kopernik.lodz.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii i Oddział Kliniczny Radioterapii
Principal Investigator Name
Krzysztof Roszkowski
Principal Investigator Email
roszkowskik@cm.umk.pl
Contact Person Name
Krzysztof Roszkowski
Contact Person Email
roszkowskik@cm.umk.pl
Site Name
Nu Med Grupa S.A.
Department Name
Oddział Onkologiczny
Principal Investigator Name
Andrzej Badzio
Principal Investigator Email
abadzio@gumed.edu.pl
Contact Person Name
Andrzej Badzio
Contact Person Email
abadzio@gumed.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuc i Klatki Piersiowej
Principal Investigator Name
Piotr Jaśkiewicz
Principal Investigator Email
piotr.jaskiewicz@coi.pl
Contact Person Name
Piotr Jaśkiewicz
Contact Person Email
piotr.jaskiewicz@coi.pl

Sponsor

Primary sponsor

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

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
Authorisation Status
Marketing authorisation present (prodAuthStatus 2)
Investigational Product Name
TAGRISSO (osimertinib) (40 mg and 80 mg film-coated tablets)
Active Substance
osimertinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Marketing authorisation present (prodAuthStatus 2)
Dose Levels
40 mg | 80 mg
Maximum Dose
80 mg
Combination Treatment
Yes

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