Clinical trial • Phase III • Oncology

DURVALUMAB for Non-small cell lung cancer

Phase III trial of DURVALUMAB for Non-small cell lung cancer.

Overview

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

Key dates

Initial CTIS Submission Date
24-06-2024
First CTIS Authorization Date
14-08-2024

Trial design

Randomised, placebo + platinum-based chemotherapy: placebo administered in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery. platinum-based chemotherapy options (investigator discretion, based on histology): cisplatin with pemetrexed; carboplatin with pemetrexed; carboplatin with paclitaxel; cisplatin with gemcitabine (or carboplatin with gemcitabine for patients unable to tolerate cisplatin).-controlled Phase III trial in Belgium, Spain, Netherlands and others.

Randomised
Yes
Comparator
Placebo + platinum-based chemotherapy: placebo administered in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery. Platinum-based chemotherapy options (investigator discretion, based on histology): cisplatin with pemetrexed; carboplatin with pemetrexed; carboplatin with paclitaxel; cisplatin with gemcitabine (or carboplatin with gemcitabine for patients unable to tolerate cisplatin).
Target Sample Size
525

Eligibility

Recruits 525 Vulnerable population flag selected in trial metadata. Informed consent is obtained using adult subject information sheets and informed consent forms (L1 SIS and ICF) provided for adults; country/language-specific ICFs and separate 'pregnant partner' information/ICF documents are present in the dossier. Age entry criterion is ≥18 years, and there is no mention of assent processes for minors in the available documentation..

Vulnerable Population
Vulnerable population flag selected in trial metadata. Informed consent is obtained using adult subject information sheets and informed consent forms (L1 SIS and ICF) provided for adults; country/language-specific ICFs and separate 'pregnant partner' information/ICF documents are present in the dossier. Age entry criterion is ≥18 years, and there is no mention of assent processes for minors in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years.\n- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease.\n- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment.\n- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n- No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.\n- Adequate organ and marrow function.\n- Confirmation of a patient's tumour PD-L1 status.\n- Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status.\n- Planned surgery to be performed need to include lobectomy, sleeve resection or bilobectomy.\n- A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value."}

Exclusion criteria

  • {"criterion_text":"- History of allogeneic organ transplantation.\n- Patients who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections.\n- Patients with a documented test result confirming the presence of EGFRm or ALK translocation.\n- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).\n- History of another primary malignancy.\n- History of active primary immunodeficiency.\n- Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus.\n- Deemed unresectable NSCLC by multidisciplinary evaluation.\n- Patients who have preoperative radiotherapy treatment as part of their care plan.\n- Known allergy or hypersensitivity to any of the study drugs or excipients.\n- Existence of more than one primary tumour such as mixed small cell and NSCLC histology.\n- Patients who have brain metastases or spinal cord compression.\n- Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).","definition_or_measurement_approach":"Assessed in the modified intent-to-treat (mITT) population. EFS = event-free survival (as named); pCR = pathological complete response assessed on resected tumour specimen (i.e., pathology assessment)."}

Secondary endpoints

  • {"endpoint_text":"- DFS in the modified resected population.","definition_or_measurement_approach":"Disease-free survival assessed in the modified resected population."}
  • {"endpoint_text":"- mPR (≤10% viable tumour cells in lung primary tumour after complete evaluation in the resected lung cancer specimen).","definition_or_measurement_approach":"Major pathological response (mPR) defined as ≤10% viable tumour cells in the primary lung tumour after complete evaluation of the resected specimen (definition provided verbatim in endpoint text)."}
  • {"endpoint_text":"- OS.","definition_or_measurement_approach":"Overall survival (time from randomisation to death from any cause)."}
  • {"endpoint_text":"- EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC ≥1%.","definition_or_measurement_approach":"Same endpoints (EFS, pCR, DFS, mPR, OS) evaluated in subgroup of patients with PD-L1 tumour cell (TC) expression ≥1%."}
  • {"endpoint_text":"- Change from baseline in Patient reported outcomes and time to deterioration.","definition_or_measurement_approach":"Patient-reported outcome measures compared to baseline and time-to-deterioration analyses per PRO instruments described in protocol."}
  • {"endpoint_text":"- Concentration of durvalumab.","definition_or_measurement_approach":"Pharmacokinetic assessment measuring durvalumab concentrations in blood/plasma."}
  • {"endpoint_text":"- Presence of ADAs for durvalumab.","definition_or_measurement_approach":"Immunogenicity assessment: presence of anti-drug antibodies (ADAs) against durvalumab."}

Recruitment

Planned Sample Size
525
Recruitment Window Months
50
Consent Approach
Informed consent obtained from adult participants (age ≥18) using subject information sheets and informed consent forms (L1 SIS and ICF). Country- and language-specific ICFs are provided (examples include English, Dutch, French, Spanish, Polish, Hungarian, Italian, German). Separate information/ICF documents for pregnant partners are included. No procedures or assent for minors are described in the available documentation.

Geography

Total Number Of Sites
43
Total Number Of Participants
358

Belgium

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
34
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
CHU Helora
Department Name
Oncology
Principal Investigator Name
Stéphane Holbrechts
Principal Investigator Email
stephane.holbrechts@hap.be
Contact Person Name
Stéphane Holbrechts
Contact Person Email
stephane.holbrechts@hap.be
Site Name
Az Maria Middelares Gent
Department Name
Pneumology Oncology
Principal Investigator Name
Paul Germonpré
Principal Investigator Email
paul.germonpre@azmmsj.be
Contact Person Name
Paul Germonpré
Contact Person Email
paul.germonpre@azmmsj.be

Spain

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
34
Number Of Sites
9
Number Of Participants
55

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Principal Investigator Name
Miguel Fernández de Sanmamed Gutiérrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernández de Sanmamed Gutiérrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Noemi Reguart Aransay
Principal Investigator Email
NREGUART@clinic.cat
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
NREGUART@clinic.cat
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Emilio Esteban González
Principal Investigator Email
eestebang@seom.org
Contact Person Name
Emilio Esteban González
Contact Person Email
eestebang@seom.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Dómine Gómez
Principal Investigator Email
lungtrialsfjd@gmail.com
Contact Person Name
Manuel Dómine Gómez
Contact Person Email
lungtrialsfjd@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Luis León Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis León Mateos
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
bmassutis@seom.org
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Principal Investigator Name
Alfredo Paredes Lario
Principal Investigator Email
ALFREDO.PAREDESLARIO@osakidetza.eus
Contact Person Name
Alfredo Paredes Lario
Site Name
Hospital General Universitario Dr. Balmis (duplicate/other entry)
Department Name
Oncology
Principal Investigator Name
Bartomeu Massuti Sureda
Principal Investigator Email
bmassutis@seom.org
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org

Netherlands

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
39
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Poli Lung diseases
Principal Investigator Name
Niels Claessens
Principal Investigator Email
nclaessens@rijnstate.nl
Contact Person Name
Niels Claessens
Contact Person Email
nclaessens@rijnstate.nl

Austria

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
42
Number Of Sites
5
Number Of Participants
67

Sites

Site Name
Medical University Of Vienna
Department Name
Clinical Department of Oncology
Principal Investigator Name
Thorsten Füreder
Principal Investigator Email
thorsten.fuereder@meduniwien.ac.at
Contact Person Name
Thorsten Füreder
Site Name
Medizinische Universitaet Innsbruck
Department Name
Hematology and Oncology
Principal Investigator Name
Andreas Pircher
Principal Investigator Email
Andreas.pircher@tirol-kliniken.at
Contact Person Name
Andreas Pircher
Site Name
LKH Feldkirch Intern E at LKH Rankweil
Department Name
Intern E
Principal Investigator Name
Thomas Winder
Principal Investigator Email
thomas.winder@lkhf.at
Contact Person Name
Thomas Winder
Contact Person Email
thomas.winder@lkhf.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Internal Medicine and Pneumology
Principal Investigator Name
Arschang Valipour
Principal Investigator Email
arschang.valipour@gesundheitsverbund.at
Contact Person Name
Arschang Valipour
Site Name
Medical University of Graz
Department Name
Clinical Department of Oncology
Principal Investigator Name
Gudrun Absenger
Principal Investigator Email
gudrun.absenger@uniklinikum.kages.at
Contact Person Name
Gudrun Absenger

Poland

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
36
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddzial Onkologii z Pododdzialem chemioterapii
Principal Investigator Name
Jaroslaw Kolb-Sielecki
Principal Investigator Email
j.kolbsielecki@gmail.com
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Principal Investigator Name
Robert Mroz
Principal Investigator Email
robmmroz@gmail.com
Contact Person Name
Robert Mroz
Contact Person Email
robmmroz@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Pluc i Klatki Piersiowej
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
dariusz.kowalski@nio.gov.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii
Principal Investigator Name
Renata Duchnowska
Principal Investigator Email
rduchnowska@wim.mil.pl
Contact Person Name
Renata Duchnowska
Contact Person Email
rduchnowska@wim.mil.pl

Germany

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
36
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinik Immenstadt
Principal Investigator Name
Christian Schumann
Principal Investigator Email
bernhard.heberle@klinikverbund-allgaeu.de
Contact Person Name
Christian Schumann
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Krankenhaus Koeln-Merheim
Principal Investigator Name
Eva Lotte Buchmeier
Principal Investigator Email
buchmeiere@kliniken-koeln.de
Contact Person Name
Eva Lotte Buchmeier
Contact Person Email
buchmeiere@kliniken-koeln.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Hemathology and Oncology
Principal Investigator Name
Florian Weissinger
Principal Investigator Email
Florian.weissinger@evkb.de
Contact Person Name
Florian Weissinger
Contact Person Email
Florian.weissinger@evkb.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Silvan Becker
Principal Investigator Email
silvan.becker@fdk.info
Contact Person Name
Silvan Becker
Contact Person Email
silvan.becker@fdk.info

France

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
19
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Centre Hospitalier D Avignon
Department Name
Onco Hematology
Principal Investigator Name
Nicolas CLOAREC
Principal Investigator Email
cloarec.nicolas@ch-avignon.fr
Contact Person Name
Nicolas CLOAREC
Contact Person Email
cloarec.nicolas@ch-avignon.fr
Site Name
Hopitaux Prives De Metz
Department Name
Pneumology
Principal Investigator Name
Julie PERRIN
Principal Investigator Email
julie.perrin@uneos.fr
Contact Person Name
Julie PERRIN
Contact Person Email
julie.perrin@uneos.fr
Site Name
Centre Antoine Lacassagne
Department Name
medical oncology
Principal Investigator Name
Victoria Ferrari
Principal Investigator Email
victoria.ferrari@nice.unicancer.fr
Contact Person Name
Victoria Ferrari
Site Name
HIA Sainte Anne
Department Name
medical oncology
Principal Investigator Name
Olivier BYLICKI
Principal Investigator Email
bylicki.olivier@yahoo.fr
Contact Person Name
Olivier BYLICKI
Contact Person Email
bylicki.olivier@yahoo.fr

Hungary

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
34
Number Of Sites
5
Number Of Participants
101

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
I. Pulmonológiai Osztály
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
Matrai Gyogyintezet
Department Name
Pulmonológiai Osztály
Principal Investigator Name
István Albert
Principal Investigator Email
albert.magy@gmail.com
Contact Person Name
István Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
VIII. Tüdőgyógyászati Osztály
Principal Investigator Name
Gyula Ostoros
Principal Investigator Email
drostorosgyula@gmail.com
Contact Person Name
Gyula Ostoros
Contact Person Email
drostorosgyula@gmail.com
Site Name
Reformatus Pulmonologiai Centrum
Department Name
VI. Tüdőgyógyászati Osztály
Principal Investigator Name
Gabriella Gálffy
Principal Investigator Email
ggalffy@hotmail.com
Contact Person Name
Gabriella Gálffy
Contact Person Email
ggalffy@hotmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonológiai Osztály
Principal Investigator Name
Zsuzsanna Szalai
Principal Investigator Email
clinstudy@gmail.com
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
53
Number Of Sites
9
Number Of Participants
59

Sites

Site Name
Istituto Oncologico Veneto
Department Name
UOC di Oncologia Medica 2
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
Careggi University Hospital
Department Name
Oncologia Medica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@gmail.com
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncologia Medica
Principal Investigator Name
Diego Luigi Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Luigi Cortinovis
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Divisione di Oncologia Toracica
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica
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
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncologia
Principal Investigator Name
Michele Milella
Principal Investigator Email
michele.milella@aovr.veneto.it
Contact Person Name
Michele Milella
Contact Person Email
michele.milella@aovr.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
U.S.C. Oncologia
Principal Investigator Name
Anna Cecilia Bettini
Principal Investigator Email
abettini@asst-pg23.it
Contact Person Name
Anna Cecilia Bettini
Contact Person Email
abettini@asst-pg23.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria
Site Name
Careggi University Hospital (duplicate/other entry)
Department Name
Oncologia Medica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@gmail.com
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com

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 USE
Route
Intravenous
Authorisation Status
Authorised (EU/1/18/1322/001)
Starting Dose
1500 mg
Dose Levels
1500 mg
Frequency
1500 mg every 3 weeks for up to 4 cycles pre-surgery; 1500 mg every 4 weeks post-surgery for up to 12 cycles
Maximum Dose
1500 mg
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
GEMCITABINE HYDROCHLORIDE
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
PEMETREXED DISODIUM
Active Substance
PEMETREXED DISODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Combination Treatment
Yes

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