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    Summary
    EudraCT Number:2021-004189-37
    Sponsor's Protocol Code Number:HCQHNLcancer
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-31
    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 number2021-004189-37
    A.3Full title of the trial
    Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer
    Il ruolo dell'idrossiclorochina nella strategia dei tumori del distretto Testa e Collo e nel tumore polmonare non a piccole cellule
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer
    Il ruolo dell'idrossiclorochina nella strategia dei tumori del distretto Testa e Collo e nel tumore polmonare non a piccole cellule
    A.3.2Name or abbreviated title of the trial where available
    HCQHNLcancer
    HCQHNLcancer
    A.4.1Sponsor's protocol code numberHCQHNLcancer
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportFondo di ricerca Oncologia medica OSR
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 58
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226436920
    B.5.5Fax number000000
    B.5.6E-mailctc@hsr.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 PLAQUENIL - 200 MG COMPRESSE RIVESTITE 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS S.P.A.
    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 nameIdrossiclorochina Solfato
    D.3.2Product code [Idrossiclorochina Solfato]
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIdrossiclorochina Solfato
    D.3.9.1CAS number 118-42-3
    D.3.9.2Current sponsor codeIdrossiclorochina Solfato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Patients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx), or Resectable Non-small cell lung cancer (NSCLC, only Lung Squamous Cell Carcinoma or Adenocarcinoma).
    Pazienti affetti da Carcinoma resecabile del distretto Testa e del collo (Carcinoma Squamocellulare del cavo orale o della laringe) o Carcinoma polmonare non a piccole cellule resecabile (Carcinoma squamocellulare o Adenocarcinoma del polmone).
    E.1.1.1Medical condition in easily understood language
    Patients affected by Resectable Head and Neck (HN) cancer, or Resectable Non-small cell lung cancer.
    Pazienti affetti da Carcinoma resecabile del distretto Testa e del collo o Carcinoma polmonare non a piccole cellule resecabile.
    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 LLT
    E.1.2Classification code 10078181
    E.1.2Term Laryngeal squamous cell carcinoma stage 0
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10030964
    E.1.2Term Oral carcinoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037352
    E.1.2Term Pulmonary carcinoma stage 0
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10025123
    E.1.2Term Lung squamous cell carcinoma stage II
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10025122
    E.1.2Term Lung squamous cell carcinoma stage I
    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 determine the biological effect of Hydroxychloroquine and its anticancer activity in patients with resectable Head and Neck cancer and Non-small cell lung cancer
    Determinare l'effetto biologico dell'idrossiclorochina e la sua attività antitumorale in pazienti con carcinoma del distretto testa e collo resecabile e carcinoma polmonare non a piccole cellule.
    E.2.2Secondary objectives of the trial
    To assess R0 resection rates.
    Valutare i tassi di resezione R0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Head and Neck Cancer group:
    - Adults > or = 18 years of age.
    - American Joint Committee on Cancer-defined clinical stage I, II, III, IV HN cancer that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
    - Squamous Cell Carcinoma (SCC) of the oral cavity or larynx
    - Treatment-naïve patients
    - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    - Patient capable giving informed consent
    - QTc interval lower than 450 msec
    - Measurable or evaluable disease defined by RECIST 1.1
    - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
    - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

    Non-small cell lung cancer group
    - Adults > or = 18 years of age.
    - American Joint Committee on Cancer-defined clinical stage IA, IB, IIA, IIB NSCLC that is deemed locally to be surgically resectable by a multidisciplinary clinical team and will receive radical surgery.
    - Lung Squamous Cell Carcinoma or Adenocarcinoma.
    - Treatment-naïve patients
    - PDL1 > 50%
    - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    - Patient capable giving informed consent
    - QTc interval lower than 450 msec
    - Measurable or evaluable disease defined by RECIST 1.1
    - For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of drug administration.
    - For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
    Gruppo HN:
    - Adulti > o = 18 anni di età.
    - Carcinoma in stadio clinico I, II, III, IV ritenuto localmente resecabile chirurgicamente da un team clinico multidisciplinare e che riceverà un intervento chirurgico radicale.
    - Carcinoma Squamocellulare del cavo orale o della laringe
    - Pazienti naïve al trattamento
    - Performance status dell'Eastern Cooperative Oncology Group (ECOG) 0-2
    - Paziente capace di dare consenso informato
    - Intervallo QTc inferiore a 450 msec
    - Malattia misurabile o valutabile definita da RECIST 1.1
    - Per le donne con potenziale riproduttivo: uso di contraccettivi altamente efficaci per almeno 1 mese prima dello screening e consenso all'uso di tale metodo durante la partecipazione allo studio e per altre 4 settimane dopo la fine della somministrazione del farmaco.
    - Per i maschi con potenziale riproduttivo: uso di preservativi o altri metodi per garantire una contraccezione efficace con il partner

    Gruppo NSCLC
    - Adulti > o = 18 anni di età.
    - NSCLC in stadio clinico IA, IB, IIA, IIB , ritenuto localmente resecabile chirurgicamente da un team clinico multidisciplinare e che riceverà un intervento chirurgico radicale.
    - Carcinoma Squamocellulare o Adenocarcinoma del polmone
    - Pazienti naïve al trattamento
    - PDL1> 50%
    - Performance status dell'Eastern Cooperative Oncology Group (ECOG) 0-2
    - Paziente capace di dare consenso informato
    - Intervallo QTc inferiore a 450 msec
    - Malattia misurabile o valutabile definita da RECIST 1.1
    - Per le donne con potenziale riproduttivo: uso di contraccettivi altamente efficaci per almeno 1 mese prima dello screening e consenso all'uso di tale metodo durante la partecipazione allo studio e per altre 4 settimane dopo la fine della somministrazione del farmaco.
    - Per i maschi con potenziale riproduttivo: uso di preservativi o altri metodi per garantire una contraccezione efficace con il partner
    E.4Principal exclusion criteria
    - Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines4
    - Bradycardia or reduction in heart rhythm with arrhythmia
    - Uncorrected hypokalemia and/or hypomagnesemia
    - Ischemic heart disease
    - Congestive heart failure with use of diuretics
    - Pre-existing retinopathy or maculopathy5
    - Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
    - Known galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
    - Known prolonged QT syndrome or current use of drugs with known prolongation of QT/QTc interval.
    - Any regular concomitant medication which is contraindicated in the use together with HCQ
    - Diabetes type 1
    - Haematopoietic systems diseases
    - Myasthenia gravis
    - Pregnant or breastfeeding women
    - Patients with Nasogastric or PEG feeding tube
    - Patients with deterioration of performance status beyond ECOG 2
    - Ipersensibilità all'idrossiclorochina, alla clorochina o ad altre 4-amminochinoline
    - Bradicardia o riduzione del ritmo cardiaco con aritmia
    - Ipopotassiemia e / o ipomagnesiemia non corrette
    - Cardiopatia ischemica
    - Insufficienza cardiaca congestizia con l'uso di diuretici
    - Retinopatia o maculopatia preesistente
    - Carenza nota di glucosio-6-fosfato deidrogenasi (anemia emolitica, favismo)
    - Intolleranza nota al galattosio, deficit totale di lattasi o malassorbimento di glucosio-galattosio
    - Nota sindrome del QT prolungato o uso corrente di farmaci con noto prolungamento dell'intervallo QT / QTc.
    - Qualsiasi farmaco concomitante regolare che è controindicato nell'uso insieme a HCQ
    - Diabete di tipo 1
    - Malattie dei sistemi ematopoietici
    - Miastenia grave
    - Donne in gravidanza o che allattano
    - Pazienti con sondino nasogastrico o PEG
    - Pazienti con deterioramento del performance status oltre ECOG 2
    E.5 End points
    E.5.1Primary end point(s)
    Immunohistochemical studies will be performed for known autophagic and immunological markers (CD3, CD8, CD163, p53, p62, LC3) with quantification of positivity / total cells, intensity, expression pattern.
    Saranno effettuati studi immunoistochimici per marcatori autofagici e immunologici noti (CD3, CD8, CD163, p53, p62, LC3) con quantificazione di positività/cellule totali, intensità, pattern di espressione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Histopathological analysis at day 0 (diagnostic biopsy) and at day 16 (tumor specimen)
    Analisi istopatologica al giorno 0 (biopsia diagnostica) e al giorno 16 (campione tumorale)
    E.5.2Secondary end point(s)
    Identification and quantification of margins’ resection status (R0, R1, R2)
    Identificazione e quantificazione dello stato di resezione dei margini (R0, R1, R2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intraoperative assessment and histopathological analysis at day 16 (tumor specimen)
    Valutazione intraoperatoria e analisi istopatologica al giorno 16 (campione tumorale)
    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 Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    evaluate the biological effect of hydroxychloroquine as an antitumor agent in relation to the changes detected on tumor cells and on the tumor immune microenvironment in relation to the inhibition of autophagy (cellular catabolic process involved in tumor proliferation).
    valutare l’effetto biologico di idrossiclorochina come agente antitumorale in relazione alle modifiche rilevate sulle cellule tumorali e sul microambiente immunitario tumorale in relazione all’inibizione di autofagia (processo catabolico cellulare coinvolto nella nella proliferazione tumorale).
    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 No
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    All patients will undergo preoperative HCQ administration followed by standard treatment (surgery). At the end of the study, all patients will have regular follow-up visits according to their disease standard therapy.
    Tutti i pazienti saranno sottoposti alla somministrazione di HCQ preoperatoria seguita dal trattamento standard (chirurgia). Alla fine dello studio tutti i pazienti avranno regolari visite di follow-up secondo la terapia standard della loro malattia.
    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 Decision2022-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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