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    Summary
    EudraCT Number:2019-004025-24
    Sponsor's Protocol Code Number:IRFMN-NSCLC-8187
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004025-24
    A.3Full title of the trial
    BRIDGE trial: Phase II trial of durvalumaB and chemotheRapy Induction followed by Durvalumab and radiotherapy in larGe volumE stage III NSCLC
    Studio BRIDGE: studio di fase II su un trattamento con durvalumab e chemioterapia di induzione seguita da durvalumab e radioterapia in pazienti con tumore polmonare non a piccole cellule di grandi dimensioni in stadio III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the activity and safety of a treatment with an antibody in association with chemotherapy in a first phase, and with radiotherapy in a second phase, in patients with advanced non-small cell lung cancer of large volume
    Studio sull’attività e la sicurezza di un trattamento con un anticorpo in associazione a chemioterapia in una prima fase, e a radioterapia in una seconda fase, in pazienti con tumore al polmone non a piccole cellule di grandi dimensioni in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    BRIDGE
    BRIDGE
    A.4.1Sponsor's protocol code numberIRFMN-NSCLC-8187
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCSS - ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.5.2Functional name of contact pointUnità Project Management, Laborator
    B.5.3 Address:
    B.5.3.1Street AddressVia Mario Negri, 2
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014661
    B.5.5Fax number0233200231
    B.5.6E-mailbridge@marionegri.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IMFINZI - 50 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 10 ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDurvalumab
    D.3.2Product code [Durvalumab]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codedurvalumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale interamente umano
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced non-small cell lung cancer in stage III
    Carcinoma del polmone non a piccole cellule di stadio III localmente avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced lung cancer
    Tumore del polmone in stadio avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To increase the proportion of patients with NSCLC in stage III eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls
    Aumentare la proporzione di pazienti con carcinoma del polmone non a piccole cellule di stadio III eleggibili all’immunoterapia combinata a radioterapia, dopo una fase di induzione con durvalumab concomitante a chemioterapia, in confronto a controlli storici
    E.2.2Secondary objectives of the trial
    (1) to evaluate Progression-free Survival (PFS) of patients using RECIST 1.1 criteria according to investigators and blinded central review (BCR); (2) to evaluate response rate of each phase of treatment and the overall response rate using RECIST 1.1 criteria, according to investigators and BCR; (3) to evaluate overall survival (OS) of treated patients; [the trial will assess the efficacy and activity of durvalumab combined with induction chemotherapy, definitive radiotherapy and as consolidation treatment, in terms of PFS, OS and response rate]; (4) to evaluate toxicity and safety of each part of the program.
    (1) valutare la sopravvivenza libera da progressione (PFS) dei pazienti trattati secondo i criteri RECIST 1.1, sia in base alla valutazione degli sperimentatori locali sia in base all’esito della revisione centralizzata in cieco (BCR); (2) valutare il tasso di risposta a ciascuna fase di trattamento e il tasso di risposta globale utilizzando i criteri RECIST 1.1, sia in base alla valutazione degli sperimentatori locali sia in base all’esito della BCR; (3) valutare la sopravvivenza globale (OS) dei pazienti trattati; [lo studio mira a valutare l’efficacia e l’attività del trattamento con durvalumab combinato a chemioterapia di induzione (parte 1), a radioterapia (parte 2) e come trattamento di consolidamento in termini di PFS, OS, ORR)] (4) valutare la tossicità e la sicurezza ad ogni fase dello studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) provision of signed, written and dated informed consent, (2) male or female aged 18 years or older, (3) histologically- or cytologically-documented locally advanced NSCLC (Stage III-v.8 IASLC), (4) patient eligible for platinum-based chemotherapy (platinum – pemetrexed for non-squamous and platinum- vinorelbine for squamous histology), (5) patient not eligible for surgery and chemoradiation (each patient will be discussed in a web multidisciplinary team among all the three involved Cancer Core Europe [CCE] centers) (6) tumor sample requirements: availability of an archived tumor tissue block (or unstained slides to perform local PDL1 assessment following protocol procedure), (7) patient’s willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives test for female pre-menopausal patients, (8) life expectancy =12 weeks at the start of treatment, (9) ECOG Performance Status of 0 – 1, (10) Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients, (11) patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up, (12) adequate organ and marrow function, (13) absence of a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to durvalumab and/or to any of their excipients.
    (1) disponibilità del consenso informato scritto, firmato e datato, (2) età pari o superiore a 18 anni, (3) diagnosi istologica o citologica di NSCLC localmente avanzato (stadio III secondo v.8 IASLC), (4) paziente candidabile a chemioterapia a base di platino (platino+pemetrexed per l’istologia non-squamosa e platino+vinorelbina per l’istologia squamosa), (5) paziente non candidabile a chirurgia o chemio-radioterapia (l’eleggibilità di ogni paziente sarà discussa in un team multidisciplinare via web composto da membri dei tre centri del Cancer Core Europe [CCE]), (6) disponibilità di un blocchetto di tessuto tumorale d’archivio (o sezioni di tumore non colorate per eseguire localmente le analisi su PD-L1 secondo le procedure descritte nel protocollo), (7) disponibilità del paziente ad eseguire i prelievi di sangue per la raccolta dei campioni ematici per le analisi di ricerca secondo le finalità dello studio, (8) aspettativa di vita uguale o superiore alle 12 settimane all’inizio del trattamento, (9) ECOG Performance Status di 0–1, (10) evidenza di stato post-menopausale o per le donne in pre-menopausa test di gravidanza su urine o sangue negativo, (11) volontà e capacità del paziente di aderire al protocollo per tutta la durata dello studio, inclusi i trattamenti, le visite previste, gli esami e il periodo di follow-up, (12) funzionalità d’organo e midollare adeguata, (13) assenza di una nota iper-sensitività severa (grado = 3) a qualsiasi agente chemioterapico di studio e/o al durvalumab e/o a qualsiasi loro eccipiente
    E.4Principal exclusion criteria
    (1) stage IV NSCLC, (2) patient amenable to curative intent surgery or concurrent chemoradiation, (3) mixed small cell and non-small cell lung cancer histology, (4) patients who already received therapy for locally advanced NSCLC, (5) dyspnea of minimal exertion or oxygen requirement, (6) recent medical history of cardiac events during the last 6 months (ischemic or congestive heart failure), (7) pancoast tumors, (8) previous radiotherapy to the thorax (prior to inclusion), including radiotherapy for breast cancer, (9) prior exposure to any anti-PD-1 or anti-PD-L1 antibody, (10) participation in another clinical study with an investigational product during the last 4 weeks, (11) any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment, (12) active or prior documented autoimmune disease within the past 2 years, (13) uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent, (14) history of another primary malignancy except for: malignancy treated with curative intent and with no known active disease =3 years before the first dose of study drug and of low potential risk for recurrencem, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, superficial bladder cancer without evidence of disease, adequately treated carcinoma in situ without evidence of disease, eg, cervical cancer in situ, (15) female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control, (16) any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
    (1) NSCLC in stadio IV, (2) paziente eleggibile a chirurgia con intento curativo o chemio-radioterapia concomitante, (3) istologia mista di tumore polmonare a piccole cellule e non a piccole cellule, (4) pazienti che hanno già ricevuto terapia per il NSCLC localmente avanzato, (5) dispnea da sforzo minimo o necessità di ossigeno, (6) recente anamnesi di eventi cardiaci negli ultimi 6 mesi (cardiopatia ischemica o scompenso cardiaco congestizio), (7) tumori di Pancoast, (8) precedente radioterapia al torace (prima dell’arruolamento), inclusa la radioterapia per tumore alla mammella, (9) precedente esposizione a qualsiasi anticorpo anti-PD-1 o anti-PD-L1, (10) partecipazione ad un altro studio clinico con prodotto sperimentale nelle ultime 4 settimane, (11) qualsiasi chemioterapia, immunoterapia, terapia biologica o terapia ormonale concomitante per il trattamento del tumore, (12) malattia autoimmune attiva o precedentemente diagnosticata negli ultimi 2 anni, (13) malattia concomitante non controllata incluso, ma non limitato a, infezione in corso o attiva, scompenso cardiaco congestizio sintomatico, ipertensione non controllata, angina pectoris instabile, aritmia cardiaca, ulcera peptica attiva o gastrite, diatesi emorragiche attive, pazienti con evidenza di epatite B o C acuta o cronica, o virus dell'immunodeficienza umana (HIV) o malattie psichiatriche/situazioni sociali che limiterebbero l’aderenza alle richieste dello studio o comprometterebbero la capacità del paziente di fornire il consenso informato scritto, (14) anamnesi di altra neoplasia maligna primaria, ad eccezione di cancro trattato con intento curativo e senza malattia attiva nota nei 3 anni antecedenti la prima dose del farmaco di studio e con basso rischio di recidiva, carcinoma della pelle non-melanoma adeguatamente trattato o lentigo maligna senza evidenza di malattia, carcinoma superficiale della vescica senza evidenza di malattia, carcinoma in situ adeguatamente trattato senza evidenza di malattia, ad es. tumore della cervice uterina in situ, (15) donne in stato di gravidanza, in allattamento o pazienti di sesso maschile o femminile in età fertile che non utilizzano efficaci metodi contraccettivi, (16) qualsiasi condizione che, a giudizio dello sperimentatore, interferirebbe con la valutazione del farmaco in studio o della sicurezza del paziente o con i risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy.
    percentuale di pazienti candidabili alla radioterapia+immunoterapia dopo induzione con durvalumab e chemioterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of part 1 of the study (induction with durvalumab + chemotherapy). In particular, the study has a Simon 2 stages design and the firt assessment of primary endpoint will be performed when 37 patients are enrolled
    Al termine della fase 1 dello studio (induzione con durvalumab + chemioterapia). In particolare lo studio ha disegno di Simon a 2 stadi e la prima valutazione dell’endpoint primario sarà eseguita quando saranno stati arruolati 37 pazienti.
    E.5.2Secondary end point(s)
    Overall Survival (OS); Objective Response Rate (ORR); SECONDARY SAFETY ENDPOINTS: to assess adverse reactions (ARs) and the frequency and nature of serious adverse events (SAEs). [adverse events will be graded according to NCI CTCAE, version 5.0.]; the change from baseline for vital signs, laboratory data, ECGs and physical examination, the QT interval corrected for heart rate using Fridericia’s formula (QTcF), calcium corrected for albumin.; Progression Free Survival (PFS)
    Sopravvivenza globale (OS, Overall Survival); Tasso di risposta obiettiva (ORR, Objective Response Rate); ENDPOINT SECONDARI DI SICUREZZA: valutare le reazioni avverse (AR, adverse reaction) e la frequenza e la natura degli eventi avversi seri (SAE, Serious Adverse Event) [gli eventi avversi saranno valutati secondo i criteri NCI-CTCAE versione 5.0]; i cambiamenti, rispetto al baseline, di segni vitali, risultati degli esami di laboratorio, risultati degli ECG eseguiti e dell’esame fisico; l’intervallo QT corretto per la frequenza cardiaca usando la formula di Fridericia (QTcF); calcio corretto per l'albumina.; Sopravvivenza libera da progressione (PFS, Progression Free Survival)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: is defined as the time from the date of start of induction treatment until death due to any cause.; ORR: is defined as the proportion of patients with CR or PR (as best response) according to RECIST 1.1 as assessed by Investigators and BCR; ORR will be presented for each of the three phases of the trial and overall. RADIOLOGICAL TUMOR EVALUATION WILL BE PERFORMED AT BASELINE, EVETY 6 WEEKS (± 1w) FOR PART 1, AT 2 WEEKS (± 1w) AFTER THE END OF PART 2, THEN EVERY 8 WEEKS (± 1w) FOR THE FIRST 4 MONTHS OF CONSOLIDATION TREATMENT AND EVERY 12 WEEKS (± 1w) THEREAFTER UNTIL CONFIRMED OBJECTIVE DISEASE PROGRESSION OR DEATH (WHICHEVER COMES FIRST). FDG-PET WILL BE PERFORMED BEFORE PART 1, AT THE END OF PART 1/BEFORE PART 2, EARLY AFTER (2 WEEKS) PART 2, AT 1 YEAR AND AT 2 YEARS.; SECONDARY SAFE
    OS: tempo intercorso tra l’inizio della terapia di induzione e la data di morte per qualsiasi causa.; ORR: proporzione di pazienti in risposta completa o risposta parziale (come migliore risposta) secondo i criteri RECIST 1.1, sia in base alla valutazione degli sperimentatori locali sia in base all’esito della revisione centralizzata in cieco (BCR); l’ORR sarà valutata sia per ciascuna delle 3 fasi dello studio sia come ORR globale. LE VALUTAZIONI RADIOLOGICHE DELLA MALATTIA SARANNO ESEGUITE AL BASELINE, OGNI 6 SETTIMANE (±1w) DURANTE LA PARTE 1, A 2 SETTIMANE (±1w) DOPO LA FINE DELLA PARTE 2, OGNI 8 SETTIMANE (±1w) PER I PRIMI 4 MESI DI MANTENIMENO E OGNI 12 MESI (±1w) FINO A CONFERMA DI PROGRESSIONE O MORTE. LA PET SARA’ ESEGUITA PRIMA DELLA PARTE 1, ALLA FINE DELLA PARTE 1/INIZIO PARTE
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    multicentrico, in aperto, a braccio singolo, disegno di Simon minimax a 2 stadi
    multicentric, open label, single arm, Simon 2 stages
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months48
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 65
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated according to clinical practice
    I pazienti seguiranno trattamenti secondo pratica clinica.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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