Clinical trial • Phase III • Oncology

DURVALUMAB for Non-small cell lung cancer (locally advanced, Stage III, unresectable)

Phase III trial of DURVALUMAB for Non-small cell lung cancer (locally advanced, Stage III, unresectable).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (locally advanced, Stage III, unresectable)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-12-2023
First CTIS Authorization Date
13-02-2024

Trial design

Randomised, arm c: durvalumab on day 1 of each 28-day cycle + placebo on days 1 and 15 of cycles 1 and 2, then on day 1 of each subsequent 28-day cycle for up to 12 months (n = 333).-controlled Phase III trial in Spain, France, Germany and others.

Randomised
Yes
Comparator
Arm C: durvalumab on Day 1 of each 28-day cycle + placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months (n = 333).
Target Sample Size
1252
Trial Duration For Participant
1825

Eligibility

Recruits 1252 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants are adults (≥18 years). Subject information and informed consent forms are provided (multiple versions present in the dossier) including specific ICFs for pregnant participants and for pregnant partners and genetic research; consent is obtained from adult participants. No assent procedures or minor/child consent are described in the provided criteria..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants are adults (≥18 years). Subject information and informed consent forms are provided (multiple versions present in the dossier) including specific ICFs for pregnant participants and for pregnant partners and genetic research; consent is obtained from adult participants. No assent procedures or minor/child consent are described in the provided criteria.

Inclusion criteria

  • {"criterion_text":"- •Participant must be ≥ 18 years at the time of screening.\n- •Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease\n- •Provision of a tumour tissue sample obtained prior to CRT\n- •Documented tumour PD-L1 status by central lab\n- •Documented EGFR and ALK wild-type status (local or central).\n- •Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy\n- •Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy\n- •Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.\n- •WHO performance status of 0 or 1 at randomization\n- •Adequate organ and marrow function"}

Exclusion criteria

  • {"criterion_text":"- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.\n- •Mixed small cell and non-small cell lung cancer histology.\n- •Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.\n- •Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.\n- •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).\n- •Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.\n- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis – regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.\n- •Active or prior documented autoimmune or inflammatory disorders (with exceptions)\n- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. Up to 5 years after first patient randomized.","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) using RECIST 1.1; follow-up up to 5 years after first patient randomized."}

Secondary endpoints

  • {"endpoint_text":"- \"To demonstrate superiority of durvalumab+oleclumab & durvalumab+monalizumab relative to durvalumab+placebo in patients with unresectable Stage III NSCLC who have not progressed on prior platinum-based cCRT; assessment by OS, OS24, ORR, DoR, PFS6, PFS12, PFS18, PFS24, PFS2, TTDM, TFST, PFS as assessed by Investigator To investigate relationship between patient’s PD-L1 expression on tumor cells & efficacy outcomes with durvalumab+oleclumab, durvalumab+monalizumab & durvalumab+placebo To assess PK of durvalumab when in combination with oleclumab & with monalizumab To assess PK of oleclumab when in combination with durvalumab To assess PK of monalizumab when in combination with durvalumab To investigate immunogenicity of durvalumab,oleclumab & monalizumab To assess time to deterioration in pulmonary symptoms\"","definition_or_measurement_approach":"As stated: assessment by overall survival (OS), OS24, objective response rate (ORR), duration of response (DoR), PFS at specified timepoints (PFS6/PFS12/PFS18/PFS24/PFS2), time to distant metastasis (TTDM), time to first subsequent therapy (TFST), PFS as assessed by Investigator; additional assessments include relationships with PD-L1 expression, PK of durvalumab/oleclumab/monalizumab, immunogenicity, and time to deterioration in pulmonary symptoms. Specific measurement definitions beyond the list above are not provided in the extracted text."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
1252
Recruitment Window Months
76
Consent Approach
Informed consent obtained from adult participants (participants must be ≥ 18). Subject information and informed consent forms (SIS and ICF) are provided with multiple country/language versions (documents present for Polish, German, Spanish, French, Portuguese, Italian among others). Dedicated ICF versions exist for adult Part I/Part II, genetic research, and pregnant participants/partners. No assent for minors described.

Methods

  • Country-specific recruitment arrangements and materials (documents present in dossier): posters (e.g. 'Poster_DE_German', 'poster-charting-new-course-nsclc'), pamphlets, patient leaflets and pamphlets (country versions), HCP reference letters ('HCPRefLet'), patient-facing materials (posters, pamphlets, thank-you cards, study participation cards), and printed recruitment materials (PSTR/PSG) as indicated by document titles.
  • Digital recruitment materials: e-cards ('ecard' documents), electronic guidance/ecard materials and other digital patient-facing assets (titles include 'ecard' and 'pac-9-ecard').
  • Patient-facing questionnaires and study information (NSCLC-SAQ and other questionnaires) for potential participants.

Geography

Total Number Of Sites
59
Total Number Of Participants
437

Spain

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
807
Number Of Sites
9
Number Of Participants
108

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Domine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Domine Gomez
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
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 Universitario Clinico San Cecilio
Department Name
Oncology
Principal Investigator Name
Silvia Sequero Lopez
Principal Investigator Email
silsq90@gmail.com
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
silsq90@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Nuria Pardo Miranda
Principal Investigator Email
npardo@vhio.net
Contact Person Name
Nuria Pardo Miranda
Contact Person Email
npardo@vhio.net
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
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Luis Leon Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis Leon Mateos
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Pilar Garrido Lopez
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
Pilar Garrido Lopez
Contact Person Email
pilargarridol@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio (duplicate entry in record?)
Department Name
Oncology
Principal Investigator Name
Silvia Sequero Lopez
Principal Investigator Email
silsq90@gmail.com
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
silsq90@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz (duplicate entry in record?)
Department Name
Oncology
Principal Investigator Name
Manuel Domine Gomez
Principal Investigator Email
ensayoscancerpulmonfjd@gmail.com
Contact Person Name
Manuel Domine Gomez

France

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
795
Number Of Sites
12
Number Of Participants
52

Sites

Site Name
Centre Hospitalier Intercommunal de Créteil
Department Name
Service de Pneumologie
Principal Investigator Name
Christos Chouaid
Principal Investigator Email
christos.chouaid@chicreteil.fr
Contact Person Name
Christos Chouaid
Contact Person Email
christos.chouaid@chicreteil.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Département d'Oncologie Radiothérapie
Principal Investigator Name
Nicolas Pourel
Principal Investigator Email
n.pourel@isc84.org
Contact Person Name
Nicolas Pourel
Contact Person Email
n.pourel@isc84.org
Site Name
CHU De Rouen
Department Name
Département de Pneumologie
Principal Investigator Name
Florian Guisier
Principal Investigator Email
florian.guisier@chu-rouen.fr
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
CHU Gabriel-Montpied
Department Name
Service de Pneumologie
Principal Investigator Name
Patrick Merle
Principal Investigator Email
pmerle@chu-clermontferrand.fr
Contact Person Name
Patrick Merle
Contact Person Email
pmerle@chu-clermontferrand.fr
Site Name
Institut Gustave Roussy
Department Name
Département d'Oncologie Médicale
Principal Investigator Name
Fabrice Barlesi
Principal Investigator Email
fabrice.barlesi@gustaveroussy.fr
Contact Person Name
Fabrice Barlesi
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
Assistance Publique Hopitaux De Marseille
Department Name
Service Oncologie multidisciplinaire et innovations thérapeutiques
Principal Investigator Name
Laurent Greillier
Principal Investigator Email
laurent.greillier@ap-hm.fr
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
CHU Rennes Pontchaillou Hospital
Department Name
Service de Pneumologie
Principal Investigator Name
Charles Ricordel
Principal Investigator Email
charles.ricordel@chu-rennes.fr
Contact Person Name
Charles Ricordel
Contact Person Email
charles.ricordel@chu-rennes.fr
Site Name
Besancon University Hospital Center
Department Name
Service de Pneumologie
Principal Investigator Name
Virginie Westeel
Principal Investigator Email
virginie.westeel@univ-fcomte.fr
Contact Person Name
Virginie Westeel
Site Name
CHU De Bordeauxt
Department Name
Service d'Oncologie Médicale
Principal Investigator Name
Charlotte Domblides
Principal Investigator Email
charlotte.domblides@chu-bordeaux.fr
Contact Person Name
Charlotte Domblides
Site Name
Groupe Hospitalier Bretagne Sud
Department Name
Service d'Oncologie Radiothérapie
Principal Investigator Name
Delphine Argo Leignel
Principal Investigator Email
d.argoleignel@ghbs.bzh
Contact Person Name
Delphine Argo Leignel
Contact Person Email
d.argoleignel@ghbs.bzh
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
ICM Val d'Aurelle
Principal Investigator Name
Xavier Quantin
Principal Investigator Email
xavier.quantin@icm.unicancer.fr
Contact Person Name
Xavier Quantin

Germany

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
438
Number Of Sites
10
Number Of Participants
68

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Strahlenklinik
Principal Investigator Name
Marlen Haderlein
Principal Investigator Email
Marlen.Haderlein@uk-erlangen.de
Contact Person Name
Marlen Haderlein
Site Name
Franziskus Hospital Harderberg
Department Name
Zentrum für Internistische Onkologie und Hämatologie
Principal Investigator Name
Petra Hoffknecht
Principal Investigator Email
petra.hofknecht@niels-stensen-kliniken.de
Contact Person Name
Petra Hoffknecht
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
HELIOS Klinikum Erfurt GmbH
Department Name
Klinik für Pneumologie, Schlaf- und Beatmungsmedizin
Principal Investigator Name
Wolf Brunner
Principal Investigator Email
wolf.brunner@helios-gesundheit.de
Contact Person Name
Wolf Brunner
Site Name
Universitaetsklinikum Wuerzburg AöR
Principal Investigator Name
Philipp Kleine
Principal Investigator Email
kleine_p@uke.de
Contact Person Name
Philipp Kleine
Contact Person Email
kleine_p@uke.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik und Poliklinik für Strahlentherapie
Principal Investigator Name
Thomas Gauler
Principal Investigator Email
thomas.gauler@uk-essen.de
Contact Person Name
Thomas Gauler
Contact Person Email
thomas.gauler@uk-essen.de
Site Name
Klinikum Esslingen GmbH
Principal Investigator Name
Martin Fähling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Fähling
Site Name
Onkodok GmbH
Principal Investigator Name
Philipp Schütt
Principal Investigator Email
schuett@onkologie-guetersloh.de
Contact Person Name
Philipp Schütt
Site Name
Pius-Hospital Oldenburg
Department Name
Universitätsklinik für Innere Medizin – Onkologie, Klinik für Hämatologie und Onkologie
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger
Site Name
Klinikum Region Hannover GmbH (duplicate entry in record?)
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

Italy

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
820
Number Of Sites
11
Number Of Participants
32

Sites

Site Name
Careggi University Hospital
Department Name
Radioterapia Oncologica
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
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Unità Oncologica Toracica
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
Azienda Ospedaliero Universitaria Parma
Department Name
Struttura complessa Oncologia medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Struttura Semplice Dipartimentale di Oncologia Toracica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
Radioterapia Oncologica
Principal Investigator Name
Sara Ramella
Principal Investigator Email
s.ramella@policlinicocampus.it
Contact Person Name
Sara Ramella
Contact Person Email
s.ramella@policlinicocampus.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Radioterapia Oncologica
Principal Investigator Name
Paolo Borghetti
Principal Investigator Email
radioterapia@asst-spedalicivili.it
Contact Person Name
Paolo Borghetti
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
Dipartimento di Oncologia ASL 2
Principal Investigator Name
Editta Baldini
Principal Investigator Email
e.baldini@usl2.toscana.it
Contact Person Name
Editta Baldini
Contact Person Email
e.baldini@usl2.toscana.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncologia
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Careggi University Hospital (duplicate entry in record?)
Department Name
Radioterapia Oncologica
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
Azienda Ospedaliero Universitaria Parma (duplicate entry in record?)
Department Name
Struttura complessa Oncologia medica
Principal Investigator Name
Marcello Tiseo
Principal Investigator Email
mtiseo@ao.pr.it
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico (duplicate entry in record?)
Department Name
Radioterapia Oncologica
Principal Investigator Name
Sara Ramella
Principal Investigator Email
s.ramella@policlinicocampus.it
Contact Person Name
Sara Ramella
Contact Person Email
s.ramella@policlinicocampus.it

Poland

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
24-02-2025
Processing Time Days
406
Number Of Sites
8
Number Of Participants
85

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Principal Investigator Name
Maciej Krzakowski
Principal Investigator Email
lungcancer@coi.pl
Contact Person Name
Maciej Krzakowski
Contact Person Email
lungcancer@coi.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Principal Investigator Name
Bogdan Zurawski
Principal Investigator Email
bzur1@wp.pl
Contact Person Name
Bogdan Zurawski
Contact Person Email
bzur1@wp.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Principal Investigator Name
Lubomir Bodnar
Principal Investigator Email
lbodnar@szpital.siedlce.pl
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl
Site Name
Uniwersyteckie Centrum Kliniczne
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
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Principal Investigator Name
Magdalena Ciazynska
Principal Investigator Email
ciazynska.magdalena@gmail.com
Contact Person Name
Magdalena Ciazynska
Contact Person Email
ciazynska.magdalena@gmail.com
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie (duplicate entry in record?)
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med

Portugal

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
799
Number Of Sites
9
Number Of Participants
92

Sites

Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncology Department
Principal Investigator Name
Li Bei
Principal Investigator Email
li.bei@cuf.pt
Contact Person Name
Li Bei
Contact Person Email
li.bei@cuf.pt
Site Name
Champalimaud Clinical Centre
Department Name
Pneumology
Principal Investigator Name
Patrícia Winckler
Principal Investigator Email
patricia.winckler@fundacaochampalimaud.pt
Contact Person Name
Patrícia Winckler
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Oncological Pneumology
Principal Investigator Name
Direndra Hamuscrai
Principal Investigator Email
direndra@chln.min-saude.pt
Contact Person Name
Direndra Hamuscrai
Contact Person Email
direndra@chln.min-saude.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Serviço de Pneumologia
Principal Investigator Name
Fernando Barata
Principal Investigator Email
fjssbarata@gmail.com
Contact Person Name
Fernando Barata
Contact Person Email
fjssbarata@gmail.com
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pneumology
Principal Investigator Name
Gabriela Fernandes
Principal Investigator Email
maria.fernandes@chsj.min-saude.pt
Contact Person Name
Gabriela Fernandes
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Oncology Departement
Principal Investigator Name
Margarida Felizardo
Principal Investigator Email
maria.felizardo@ulslod.min-saude.pt
Contact Person Name
Margarida Felizardo
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Pneumology
Principal Investigator Name
Telma Sequeira
Principal Investigator Email
tsequeira@ipolisboa.min-saude.pt
Contact Person Name
Telma Sequeira
Site Name
Unidade Local De Saude De Loures-Odivelas EPE (duplicate entry in record?)
Department Name
Oncology Departement
Principal Investigator Name
Margarida Felizardo
Principal Investigator Email
maria.felizardo@ulslod.min-saude.pt
Contact Person Name
Margarida Felizardo
Site Name
Galo Saude Parcerias Cascais S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
Diogo Costa
Principal Investigator Email
diogo.santos.costa@hospitaldecascais.pt
Contact Person Name
Diogo Costa

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: EU/1/18/1322/002 and EU/1/18/1322/001
Frequency
Durvalumab on Day 1 of each 28-day cycle
Maximum Dose
1500 mg
Investigational Product Name
Oleclumab
Active Substance
OLECLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Frequency
Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Investigational Product Name
Monalizumab
Active Substance
MONALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Frequency
Monalizumab on Day 1 of each 28-day cycle for up to 12 months
Combination Treatment
Yes

Related trials

Other published trials that may interest you.