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    Summary
    EudraCT Number:2020-002773-10
    Sponsor's Protocol Code Number:IRFMN-LUNG-8287
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-21
    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 number2020-002773-10
    A.3Full title of the trial
    A phase III prevention trial of canakinumab in subjects at high risk for lung cancer
    Studio di prevenzione di fase III in soggetti ad alto rischio per tumore al polmone che confronta un trattamento con il farmaco canakinumab verso placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prevention trial of canakinumab in subjects at high risk for lung cancer
    Studio di prevenzione in soggetti ad alto rischio di sviluppare un tumore al polmone che mette a confronto un trattamento con il farmaco canakinumab con un trattamento con placebo
    A.3.2Name or abbreviated title of the trial where available
    CANAL
    CANAL
    A.4.1Sponsor's protocol code numberIRFMN-LUNG-8287
    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 supportNovartis Farma AG
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationistituto di Ricerche Farmacologiche Mario Negri IRCCS
    B.5.2Functional name of contact pointLaboratorio Metodologia per la Rice
    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.5.6E-mailcanal@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 No
    D.2.1.1.1Trade name Canakinumab
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm ltd
    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 nameCanakinumab
    D.3.2Product code [ACZ885]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcanakinumab
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number199
    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) No
    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 umano ricombinante
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects at high risk for lung cancer
    Soggetti ad alto rischio per tumore al polmone
    E.1.1.1Medical condition in easily understood language
    Subjects at high risk for lung cancer
    Pazienti ad alto rischio di sviluppare un tumore al polmone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10058467
    E.1.2Term Lung neoplasm malignant
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10078411
    E.1.2Term Primary prevention
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the superiority of canakinumab over placebo in terms of lung cancer incidence (LCI) in subjects at high risk for lung cancer
    Valutare la superiorità di canakinumab rispetto a placebo in termini di incidenza di tumore del polmone in soggetti ad alto rischio per tumore polmonare
    E.2.2Secondary objectives of the trial
    - Time to Lung cancer death,
    - Overall Survival (OS),
    - cancer mortality
    - shrinkage of non-solid nodules,
    - safety profile of canakinumab
    - Treatment compliance
    - Tempo intercorso tra la data di randomizzazione e la morte per tumore del polmone,
    - sopravvivenza globale (OS),
    - mortalità per tumore
    - shrinkage dei noduli non solidi
    - sicurezza
    - compliance al trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained prior to any screening procedures.
    2. Age =18 years and =75 years;
    3. PLCO risk >2,5% in 6 years to undergo CT screening;
    4. Annual risk of lung cancer =3% ( 6% at 2 years or 12% at 4 years) after the baseline CT using a second risk model which includes the presence of lung nodules such as the Brock University model [13,14];
    5. CRP levels above 3 mg/L;
    6. Former smokers or current smokers participating in smoking-cessation-programs or subjects with incidental diagnosis of undetermined nodules;
    7. Subjects must have normal organ and bone marrow function:
    a. Haemoglobin = 10.0 g/dL.
    b. Absolute neutrophil count (ANC) = 1.5 x 109/L.
    c. Platelet count = 100 x 109/L.
    d. Total bilirubin = 1.5 x institutional upper limit of normal (ULN).
    e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) = 2.5 x ULN.
    1. Consenso informato scritto ottenuto prima di intraprendere qualsiasi procedura di screening;
    2. Età compresa tra i 18 e 75 anni inclusi;
    3. Rischio PLCO> 2.5% in 6 anni di sottoporsi a TAC di screening;
    4. Rischio annuale di sviluppare un tumore del polmone =3% (6% a 2 anni o 12% a 4 anni) dopo la TAC basale utilizzando un secondo modello di rischio che include la presenza di noduli polmonari (Brock University model) [13,14]
    5. Livelli di CRP superiori a 3 mg/L;
    6. Ex fumatori o fumatori attuali che partecipano a programmi per smettere di fumare o soggetti con diagnosi incidentale di noduli indeterminati;
    7. I soggetti devono avere una normale funzione degli organi e del midollo osseo:
    a. Emoglobina = 10.0 g/dL.
    b. Conta assoluta dei neutrofili = 1.5 x 109/L.
    c. Conta delle piastrine = 100 x 109/L.
    d. Bilirubina totale = 1.5 x limite superiore di normalità istituzionale (ULN).
    e. Aspartato aminotransferasi/ Transaminasi sierica glutammico ossalacetica (ASAT/SGOT)) and Alanina aminotransferasi / Transaminasi sierica glutamico piruvica (ALAT/SGPT)) = 2.5 x ULN.
    E.4Principal exclusion criteria
    1. Active infection;
    2. Subjects with previous diagnosis of invasive cancer in the 5 years before enrolment;
    3. History or evidence of tuberculosis (TB) (active or latent) infection or one of the risk factors for tuberculosis such as but not limited or exclusive to:
    4. subjects with suspected or proven immunocompromised state, including (a) those with evidence of Human Immunodeficiency Virus (HIV) infection
    5. History or current diagnosis of cardiac disease
    6. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results).
    7. Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1ß inhibitor).
    8. Subjects who received any biologic drugs targeting the immune system at any time.
    9. all conditions contraindicating canakinumab according to summary of product characteristics according to EMA
    10. History of hypersensitivity to drugs of similar chemical classes or to canakinumab or its excipients that contraindicates the subject’s participation.
    11. Any life-threatening condition with life expectancy < 5 years that might prevent the subject from completing the study
    12. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
    13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment and for up to 3 months after last dose of study drug.
    14. Subject with nodules larger than 8 mm with Positron emission tomography (PET) SUV >2,5 for which surgical evaluation is indicated.
    1. Infezioni attive;
    2. Soggetti con diagnosi di cancro invasivo nei 5 anni precedenti l'arruolamento; 3. Storia o evidenza di infezione da tubercolosi (TBC) (attiva o latente) o uno dei fattori di rischio per la tubercolosi
    4. Pazienti con stato di immunocompromissione sospetta o accertata, inclusi (a) quelli con evidenza di infezione da virus dell'immunodeficienza umana (HIV);
    5. Anamnesi o diagnosi attuale di cardiopatia
    6. Disturbo epatico attivo o ricorrente noto, inclusa cirrosi, epatite B e C (risultati di laboratorio centrale positivi o indeterminati).
    7. Precedente trattamento con Canakinumab o farmaci con meccanismo d'azione simile (inibitore dell'IL-1ß).
    8. Soggetti che hanno ricevuto in qualsiasi momento farmaci biologici mirati al sistema immunitario.
    9. Tutte le condizioni per le quali l’uso di Canakinumab sarebbe controindicato secondo il riassunto delle caratteristiche del prodotto approvato da EMA.
    10. Storia di ipersensibilità a Canakinumab, ai suoi eccipienti o a simili classi di farmaci.
    11. Qualsiasi condizione del soggetto che prevede un’aspettativa di vita <5 anni e che potrebbe impedire il completamento dello studio.
    12. Donne incinte o in allattamento, definendo la gravidanza come lo stato di una donna a partire dal concepimento fino alla fine della gestazione, confermata da un test di laboratorio hCG positivo.
    13. Donne in età fertile, definite come tutte le donne fisiologicamente in grado di rimanere incinta, a meno che non stiano utilizzando metodi contraccettivi di base durante la somministrazione del trattamento in studio e fino a 3 mesi dopo l'ultima dose del farmaco in studio.
    14. Soggetti con noduli maggiori di 8 mm con tomografia a emissione di positroni (PET) SUV> 2,5 per i quali è indicata la valutazione chirurgica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the Time To Lung Cancer TTLC, that will be measured from the date of randomization up to the date of lung cancer or, for subjects free from disease, the date of last contact.
    L'endpoint primario è il Time To Lung Cancer (TTLC), ossia il tempo intercorso tra la data di randomizzazione e la data di insorgenza di tumore del polmone o, per i pazienti liberi da malattia, la data dell'ultimo contatto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint will be measured from the date of randomization up to the date of lung cancer or, for subjects free from disease, the date of last contact.
    Tempo intercorso tra la data di randomizzazione e la data di insorgenza di tumore del polmone o, per i pazienti liberi da malattia, la data dell'ultimo contatto.
    E.5.2Secondary end point(s)
    shrinkage dei noduli non solidi; safety profile of canakinumab; Treatment compliance; Time to Lung cancer death; Overall survival; cancer mortality
    shrinkage dei noduli non solidi; Sicurezza del farmaco; Treatment compliance; Tempo alla morte per tumore polmonare; sopravvivenza globale; Mortalità per cancro
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the randomization date to the study conclusion date; From the randomization date and up to 130 days from the last administration of drug/placebo; From the first cycle to the last administration; from the date of randomization up to the date of lung cancer diagnosis to death for lung cancer; from the randomization date to death; From date og tumor diagnosi to death
    dalla data di randomizzazione al termine dello studio; Dalla data di randomizzazione a 130 dopo l'ultima somministrazione di farmaco/placebo; l'intera durata del trattamento; Tempo intercorso tra la diagnosi di tumore al polmone e la morte a causa del tumore polmonare; tempo intercorso tra la randomizzazione e la morte per ogni causa; Dalla data di diagnosi di tumore alla data della morte per cancro
    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 No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Time To Lung Cancer
    Time To Lung Cancer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months72
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months72
    E.8.9.2In all countries concerned by the trial days21
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 349
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 700
    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)
    Prevention and clinical practice
    Prevenzione e 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 Decision2021-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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