Clinical trial • Phase III • Oncology

DURVALUMAB for Non-small cell lung cancer | Stage III unresectable non-small cell lung cancer

Phase III trial of DURVALUMAB for Non-small cell lung cancer | Stage III unresectable non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Stage III unresectable non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-11-2023
First CTIS Authorization Date
31-01-2024

Trial design

Randomised, arm a (experimental): durvalumab plus domvanalimab q4w for 12 months. arm b (control): durvalumab plus placebo q4w for 12 months. (durvalumab product name: imfinzi 50 mg/ml concentrate for solution for infusion; domvanalimab administered iv; exact per-dose mg for durvalumab not specified in provided text; domvanalimab dose unit mg/kg with a maximum listed value of 20 mg/kg in product data.) Phase III trial in Norway, Poland, Greece and others.

Randomised
Yes
Comparator
Arm A (Experimental): durvalumab plus domvanalimab q4w for 12 months. Arm B (Control): durvalumab plus placebo q4w for 12 months. (Durvalumab product name: IMFINZI 50 mg/mL concentrate for solution for infusion; domvanalimab administered IV; exact per-dose mg for durvalumab not specified in provided text; domvanalimab dose unit mg/kg with a maximum listed value of 20 mg/kg in product data.)
Biomarker Stratified
True, biomarker: PD-L1 tumor cell (TC) expression with strata TC ≥ 1% and TC ≥ 50%
Target Sample Size
580
Trial Duration For Participant
365

Eligibility

Recruits 580 isVulnerablePopulationSelected=true. Consent is collected using adult Subject Information Sheets and Informed Consent Forms (L1 SIS and ICF Adult Part I and Part II) with country-specific versions. Separate ICF documents for pregnant partners and optional genetic research are provided in the document list (e.g. "L1_ SIS and ICF Pregnant partner" and optional genetic ICFs), indicating special information/consent materials for these groups. No assent forms for minors are provided and participants must be ≥ 18 years..

Vulnerable Population
isVulnerablePopulationSelected=true. Consent is collected using adult Subject Information Sheets and Informed Consent Forms (L1 SIS and ICF Adult Part I and Part II) with country-specific versions. Separate ICF documents for pregnant partners and optional genetic research are provided in the document list (e.g. "L1_ SIS and ICF Pregnant partner" and optional genetic ICFs), indicating special information/consent materials for these groups. No assent forms for minors are provided and participants must be ≥ 18 years.

Inclusion criteria

  • {"criterion_text":"- 1. Participant must be ≥ 18 years at the time of screening.\n- 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease.\n- 3. Provision of a tumor tissue sample obtained prior to CRT.\n- 4. Documented tumor PD-L1 status ≥ 1% by central lab\n- 5. Documented EGFR and ALK wild-type status (local or central).\n- 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy\n- 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.\n- 8. 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- 9. WHO performance status of 0 or 1 at randomization\n- 10. Adequate organ and marrow function"}

Exclusion criteria

  • {"criterion_text":"- 1. History of another primary malignancy, except for: -Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. -Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease. -Adequately treated carcinoma in situ, including Ta tumors without evidence of disease. \n- 2. Mixed small cell and non-small cell lung cancer histology.\n- 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.\n- 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.\n- 5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).\n- 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.\n- 7. 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.\n- 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)\n- 9. Active EBV infection, or known or suspected chronic active EBV infection at screening\n- 10. 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) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans.","definition_or_measurement_approach":"Assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in participants with PD-L1 TC ≥ 50%. Scheduled radiological assessments as described (regular imaging intervals specified as 'every 00 weeks' in the protocol text provided)."}

Secondary endpoints

  • {"endpoint_text":"- PFS in PD-L1 TC ≥ 1% by BICR.\n- Overall Survival (OS)\n- PFS by investigator\n- PFS6\n- PFS12\n- PFS18\n- PFS24\n- OS at 24 months\n- ORR and DoR by BICR\n- PFS2\n- TTDM (Time to death or distant metastasis)\n- TFST (Time to First Subsequent Therapy)\n- PK and immunogenicity of durvalumab and domvanalimab\n- Time to First Confirmed Deterioration (TTFCD) in pulmonary symptoms measured by the NSCLC-SAQ.","definition_or_measurement_approach":"Multiple endpoints assessed by BICR and investigator assessments as specified. Survival endpoints (PFS, OS) measured from randomisation; response endpoints (ORR, DoR) assessed by BICR per RECIST 1.1; PK and immunogenicity collected per protocol; patient-reported pulmonary symptom deterioration measured using NSCLC-SAQ instrument."}

Recruitment

Digital Remote Recruitment
True, digital/remote materials are included (eCard recruitment materials listed, country-specific eCard files; patient recruitment posters available in public PDF versions for some countries).
Planned Sample Size
580
Recruitment Window Months
81
Consent Approach
Informed consent obtained from adult participants (all participants must be ≥ 18 years). Country-specific Subject Information Sheets and Informed Consent Forms (L1 SIS and ICF Adult Part I and Part II) are provided in multiple languages and versions (examples: NO, PL, GR, HU, BE English/French/Dutch, FR, ES, IT). Separate ICFs are provided for pregnant partners and optional genetic research; consent materials include translations/versions per country as listed in the document inventory.

Methods

  • Site-based recruitment at participating hospitals and oncology clinics (country-specific site lists provided).
  • Use of patient-facing recruitment materials: patient recruitment posters and pamphlets (country-specific versions: e.g. BE English/French/Dutch, FR, ES, GR, NO, HU, PL, etc.).
  • HCP-targeted materials: HCP referral letters and HCP referral guides (examples present for HU and other countries).
  • Patient study guides, pamphlets and posters (country-specific), and eCards used as recruitment/digital materials in some countries.

Geography

Total Number Of Sites
98
Total Number Of Participants
280

Norway

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
02-02-2024
Processing Time Days
63
Number Of Sites
4
Number Of Participants
28

Sites

Site Name
Sykehuset Innlandet HF
Department Name
Department of Oncology and Radiotherapy
Contact Person Name
Daniel Heinrich
Site Name
St. Olavs Hospital HF
Department Name
Clinic of Oncology
Contact Person Name
Tarje Onsøien Halvorsen
Contact Person Email
tarje.halvorsen@gmail.com
Site Name
Nordlandssykehuset HF
Department Name
Department of Oncology
Contact Person Name
Siv Gyda Aanes
Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Contact Person Name
Vilde Dragested Haakensen
Contact Person Email
VDD@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
20-02-2024
Processing Time Days
11
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Katowickie Centrum Onkologii Sp. z o.o.
Department Name
Zaklad Radioterapii
Contact Person Name
Robert Kwiatkowski
Contact Person Email
rkwiat11@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
II Klinika Radioterapii i Chemioterapii
Contact Person Name
Rafał Suwiński
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Zaklad Radioterapii
Contact Person Name
Adam Maciejczyk
Contact Person Email
adam.maciejczyk@dcopih.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie (Gliwice - another site)
Department Name
II Klinika Radioterapii I Chemioterapii
Contact Person Name
Katarzyna Galwas Kliber
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie (Warsaw site)
Department Name
Klinika Nowotworow Pluca I Klatki Piersiowej
Contact Person Name
Marta Olszyna-Serementa
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Radioterapii
Contact Person Name
Ewa Sierko
Contact Person Email
ewa.sierko@iq.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Zaklad Teleradioterapii
Contact Person Name
Jacek Fijuth
Contact Person Email
jacek.f@poczta.onet.pl

Greece

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
199
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
Oncology Clinic
Contact Person Name
Vassilios Geogoulias
Contact Person Email
georgouliasv@gmail.com
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Pathology Oncology Clinic
Contact Person Name
Georgios Lazaridis
Contact Person Email
georlaz@yahoo.gr
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Metropolitan Hospital
Department Name
4rth Oncology Clinic
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@otenet.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Contact Person Name
Georgios Fountzilas
Contact Person Email
fountzil@auth.gr
Site Name
University General Hospital Attikon
Department Name
Division of Oncology, 2nd Department of Internal Medicine, Propaedeutic
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine, Oncology Unit
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Centre Jean Perrin
Department Name
Medical Oncology
Contact Person Name
Pascale DUBRAY LONGERAS
Site Name
Additional Greek participating site (listed in Greece block)

Belgium

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
02-02-2024
Processing Time Days
63
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
CHU Helora
Department Name
Service de Recherche Clinique (SeReC), Level 5A
Contact Person Name
Gaetan Catala
Contact Person Email
gaetan.catala@jolimont.be
Site Name
Vitaz
Contact Person Name
Koen Deschepper
Contact Person Email
koen.deschepper@vitaz.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Pneumologie
Contact Person Name
Frédérique Bustin
Contact Person Email
frederique.bustin@citadelle.be
Site Name
Antwerp University Hospital
Department Name
Thoracic Oncology
Contact Person Name
Reinier Wener
Contact Person Email
reinier.wener@uza.be
Site Name
Chirec
Department Name
Chirec Cancer Institute (CCI)
Contact Person Name
Christophe Compère
Contact Person Email
christophe.compere@chirec.be
Site Name
UZ Leuven
Department Name
Pneumology
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be

Hungary

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
02-02-2024
Processing Time Days
63
Number Of Sites
9
Number Of Participants
33

Sites

Site Name
Szent Lazar Megyei Korhaz
Department Name
Onkológiai Centrum
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
University Of Szeged (associated)
Department Name
Tüdőgyógyszati Klinika
Contact Person Name
Klára Szalontai
Contact Person Email
szalontai@deszkikorhaz.hu
Site Name
Koranyi National Institute For Pulmonology
Department Name
VIII. Tüdőgyógyászati Osztály
Contact Person Name
Gyula Ostoros
Contact Person Email
drostorosgyula@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológiai Osztály
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
Onkológiai Osztály és Kújraszerű Ellátás
Contact Person Name
Éva Mórocz
Contact Person Email
eva.morocz262@gmail.com
Site Name
Deszki Mellkasi Betegsegek Szakkorhaza
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Klára Szalontai
Contact Person Email
szalontai@deszkikorhaz.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Gyógszerterápiás Központ Mellkasi és Hasürági Daganatok és Klinikai Farmakológiai Osztály
Contact Person Name
Tünde Nagy
Contact Person Email
nagy.tunde@oncol.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Pulmonológia Osztály
Contact Person Name
Zsolt Pápai-Székely
Contact Person Email
zsoltpapai@yahoo.com
Site Name
Additional Hungarian participating site (listed in Hungary block)

Spain

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
31-01-2024
Processing Time Days
61
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
Servicio de Oncologia
Contact Person Name
Alfredo Sanchez Hernandez
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Oncologia
Contact Person Name
Isidoro Barneto Aranda
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Oncologia Medica
Contact Person Name
Silverio Ros Martinez
Contact Person Email
silverio.ros@carm.es
Site Name
University Hospital Son Espases
Department Name
Servicio de Oncologia
Contact Person Name
Raquel Marse Fabregat
Contact Person Email
raquel.marse@ssib.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Servicio de Oncologia
Contact Person Name
Laia Vila Martinez
Contact Person Email
lvila@tauli.cat
Site Name
Hospital Universitario Basurto
Department Name
Servicio de Oncologia Medica
Contact Person Name
Maria Angeles Sala Gonzalez
Site Name
Additional Spanish participating site (listed in Spain block)

Germany

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
02-02-2024
Processing Time Days
63
Number Of Sites
22
Number Of Participants
45

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinik für Radioonkologie
Contact Person Name
Cihan Ganu
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Contact Person Name
Wolfgang Schütte
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinischen Klinik III, Hämatologie und Onkologie
Contact Person Name
Hendrik Eggers
Contact Person Email
h.eggers@skbs.de
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Lungen- & Bronchialheilkunde
Contact Person Name
Kato Kambartel
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Lungenklinik/ Lungenkrebszentrum Köln- Merheim
Contact Person Name
Carolin Groß-Ophoff-Müller
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Strahlenklinik
Contact Person Name
Marlen Haderlein
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Helios Klinikum Krefeld GmbH
Department Name
Abteilung Pneumologie, Lungenzentrum
Contact Person Name
Benoit Krämer
Site Name
HELIOS Klinikum Emil von Behring GmbH
Contact Person Name
Daniel Misch
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik für Thorakale Onkologie und Palliativmedizin
Contact Person Name
Jonas Kuon
Contact Person Email
Jonas.kuon@slk-kliniken.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Innere Medizin III, Hämatologie und Onkologie
Contact Person Name
Stephanie Combs
Contact Person Email
stephanie.combs@tum.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinikum für Radioonkologie
Contact Person Name
Gunther Glautke
Contact Person Email
g.klautke@skc.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Medizinische Klinik IV, Organonkologie
Contact Person Name
Thomas Wehler
Site Name
Katholisches Klinikum Koblenz Montabaur gGmbH
Contact Person Name
Selina Hein
Contact Person Email
s.hein@bbtgruppe.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik und Poliklinik für Strahlentherapie
Contact Person Name
Thomas Gauler
Contact Person Email
Thomas.Gauler@uk-essen.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Medizin II
Contact Person Name
Christian Schulz
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Abteilung für Onkologie und Hämatologie
Contact Person Name
Anke Schlenska-Lange
Site Name
Additional German participating site (listed in Germany block)

Italy

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
07-02-2024
Processing Time Days
68
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Humanitas Research Hospital
Department Name
U.O. Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 2
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncologia Medica
Contact Person Name
Francesco Cortiula
Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
U.S.C. Oncologia
Contact Person Name
Anna Cecilia Bettini
Contact Person Email
abettini@asst-pg23.it

Romania

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
05-02-2024
Processing Time Days
66
Number Of Sites
13
Number Of Participants
15

Sites

Site Name
Sigmedical Services S.R.L.
Department Name
Medical Oncology
Contact Person Name
Doine Elena Ganea
Contact Person Email
office@sigmed.ro
Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Medical Oncology
Contact Person Name
Georgeta Polixenia Iorga
Contact Person Email
georgeta.iorga@suub.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Medical Oncology
Contact Person Name
Andrei Ungureanu
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology
Contact Person Name
Aurelia Alexandru
Contact Person Email
secretariat@iob.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Medical Oncology
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
roxana.scheusan@oncocenter.ro
Site Name
Pelican Impex S.R.L.
Department Name
Medical Oncology
Contact Person Name
Ioana Adriana Ciurescu
Contact Person Email
callcenter@spitalpelican.ro
Site Name
Spitalul Clinic Judetean De Urgenta Sibiu
Department Name
Medical Oncology
Contact Person Name
Monica Patran
Contact Person Email
oncologie@scjus.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Medical Oncology
Contact Person Name
Dana Elena Clement
Contact Person Email
dclement_6600@yahoo.com
Site Name
Additional Romanian participating site (listed in Romania block)

France

Earliest CTIS Part Ii Submission Date
01-12-2023
Latest Decision Or Authorization Date
31-01-2024
Processing Time Days
61
Number Of Sites
16
Number Of Participants
30

Sites

Site Name
Reseau De Sante Mutualiste
Department Name
Pneumology and thoracic cancerology
Contact Person Name
Fanny MAGNE
Contact Person Email
F.MAGNE@resamut.fr
Site Name
Hopital Avicenne
Department Name
Medical Thoracic Oncology
Contact Person Name
Boris DUCHEMANN
Contact Person Email
boris.duchemann@aphp.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Medical Oncology
Contact Person Name
Aurelien GOBERT
Contact Person Email
agobert@vivalto-sante.com
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Contact Person Name
Frederic BIGOT
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
Respiratory disease
Contact Person Name
Stephanie MARTINEZ
Contact Person Email
smartinez@ch-aix.fr
Site Name
Centre Hospitalier De Pau
Department Name
Pneumology
Contact Person Name
Aldo RENAULT
Contact Person Email
aldo.renault@ch-pau.fr
Site Name
Centre Jean Perrin
Department Name
Medical Oncology
Contact Person Name
Pascale DUBRAY LONGERAS
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Pneumology
Contact Person Name
Charles DAYEN
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Medical Oncology
Contact Person Name
Romain CORRE
Contact Person Email
romain.corre@ch-cornouaille.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Elisabeth GAYE
Contact Person Email
e-gaye@o-lambret.fr
Site Name
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Department Name
Pneumology and thoracic cancerology
Contact Person Name
Charles NALTET
Contact Person Email
cnaltet@ghpsj.fr
Site Name
Hopitaux Prives De Metz
Department Name
Pneumology
Contact Person Name
Lucile ROUSSEL
Contact Person Email
lucile.roussel@uneos.fr
Site Name
Centre Hospitalier Du Pays D Aix (additional listing)
Site Name
Additional French participating site (listed in France block)

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 (EU/1/18/1322/002) - authorised product (IMFINZI).
Frequency
q4w (every 4 weeks) for 12 months (per arm description)
Investigational Product Name
DOMVANALIMAB
Active Substance
DOMVANALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Investigational product (sponsor product code AB154); product record present (PRD9450051).
Frequency
q4w (every 4 weeks) for 12 months (per arm description)
Maximum Dose
20 mg/kg (maxDailyDoseAmount listed as 20 mg/kg in product data)
Investigational Product Name
PLACEBO
Modality
Other
Authorisation Status
N/A (placebo comparator)
Frequency
q4w (every 4 weeks) for 12 months (per control arm description)
Combination Treatment
Yes

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