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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2015-005605-36
    Sponsor's Protocol Code Number:SCI-Ta1-NSCLC-CHEMOP2-001
    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:2019-01-18
    Trial results View 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 number2015-005605-36
    A.3Full title of the trial
    Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
    Studio di Fase II per valutare l’attività della Timosina alfa 1 aggiunta alla chemioterapia standard di mantenimento (più cisplatino o carboplatino) in pazienti con carcinoma polmonare
    non a piccole cellule metastatico, EGFR wild type
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type.
    Studio di Fase II per valutare l’attività della Timosina alfa 1 aggiunta alla chemioterapia standard di mantenimento (più cisplatino o carboplatino) in pazienti con carcinoma polmonare
    non a piccole cellule metastatico, che non presentino mutazioni sensibilizzanti dell’ EGFR.
    A.3.2Name or abbreviated title of the trial where available
    SCI-Ta1-NSCLC-CHEMO P2-001
    SCI-Ta1-NSCLC-CHEMO P2-001
    A.4.1Sponsor's protocol code numberSCI-Ta1-NSCLC-CHEMOP2-001
    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 SponsorSCICLONE PHARMACEUTICALS ITALY S.R.L.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSciClone Pharmaceuticals Italy
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSciclone Pharmaceuticals Italy Srl
    B.5.2Functional name of contact pointProcuratore Speciale
    B.5.3 Address:
    B.5.3.1Street AddressVia di Tiglio 126
    B.5.3.2Town/ cityLucca
    B.5.3.3Post code55100
    B.5.3.4CountryItaly
    B.5.4Telephone number05831913257
    B.5.5Fax number058391457
    B.5.6E-mailfrancesco.dicostanzo@icloud.com
    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 ZADAXIN - 1.6 MG/ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderSCICLONE PHARMACEUTICALS ITALY S.R.L.
    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 nameZADAXIN
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
    carcinoma polmonare non a piccole cellule metastatico con EGFR non mutato
    E.1.1.1Medical condition in easily understood language
    metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
    carcinoma polmonare non a piccole cellule metastatico con EGFR non mutato
    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 10064049
    E.1.2Term Lung adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the activity/efficacy in terms of PFS of SoC chemotherapy with cisplatin (or carboplatin) and either Pemetrexed, Paclitaxel, Gemcitabine, or Bevacizumab+Thymosin alpha 1
    in patients with advanced EGFR wild type NSCLC as compared to a control group of patients
    receiving SoC chemotherapy alone.
    Valutare l’attività/efficacia (in termini di progression free survival - PFS) della Timosina alfa 1
    in associazione alla chemioterapia standard + cisplatino (o carboplatino) confrontata con la sola chemioterapia+ cisplatino (o carboplatino) in pazienti con tumore polmonare non a piccole
    cellule che non presentino mutazioni sensibilizzanti dell’ EGFR.
    E.2.2Secondary objectives of the trial
    Overall Survival (OS);
    Quality of Life (QoL);
    Organ failure free days;
    Safety;
    Biomarkers of immunity and inflammation.
    Sopravvivenza globale;
    Qualità della vita;
    I giorni senza insufficienza d’organo;
    I biomarcatori di immunità e dell’infiammazione;
    Sicurezza;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 years or older;
    Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples will be enrolled;
    Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy ;
    Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a
    lesion not previously irradiated or non-measurable disease;
    Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2;
    Absolute neutrophil count (ANC) > 1.5 x 10 9 /liter (L) and platelets > 100 x 10 9 /L ;
    Bilirubin level either normal or <1.5 x ULN;
    AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤5 x ULN if liver metastases are present);
    Serum creatinine <1.5 x ULN;
    Effective contraception for both, male and female pts, if the risk of conception exists;
    Recovery from all acute toxicities of prior therapies;
    Provision of written informed consent to the analysis of biological markers (registration).
    Età >= 18 anni;
    Conferma istologica o citologica di NSCLC;
    NSCLC localmente avanzato o metastatico, non sottoponibile a resezione chirurgica o radioterapia;
    Malattia misurabile secondo RECIST in una lesione non precedentemente trattata con radioterapia o malattia non misurabile;
    ECOG-PS 0-2;
    Neutrofili Assoluti> 1.5 x 10 9/L e piastrine > 100 x 10 9/L ;
    Bilirubina livelli normali o <1.5 x ULN;
    AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤5 x ULN se presenti metastasi epatiche);
    Creatinina sierica <1.5 x ULN;
    Efficaci metodi contraccettivi per entrambi i sessi (maschi e femmine), se esiste potenziale rischio di concepimento;
    Recupero da effetti tossici di precedenti terapie;
    Consenso Informato scritto.




    E.4Principal exclusion criteria
    Prior therapy with Thymosin alpha-1;
    Prior therapy with a study drug ;
    Newly diagnosed central nervous system (CNS) metastases that have not yet been treated
    with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or
    spinal cord compression may be considered if they have evidence of clinically stable
    disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days;
    Pregnancy or suspected pregnancy;
    Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of
    the investigator, makes it inappropriate for the patient to be enrolled in the study;
    Known severe hypersensitivity to a study drug or anyof the excipients of this product;
    Other co-existing malignancies or malignancies diagnosed within the last 5 years with the
    exception of basal cell carcinoma or cervical cancer in situ;
    Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic,
    stable, radiographic changes who are asymptomatic or patients with uncomplicated
    progressive lymphangiticcarcinomatosis need not be excluded);
    As judged by the investigator, any evidence of severe or uncontrolled systemic disease
    (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
    As judged by the investigator, any inflammatory changes of the surface of the eye;
    Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
    Precedente terapia con Timosina alfa-1;
    Precedente terapia con un nuovo farmaco;
    Recente diagnosi di metastasi a livello CNS che non sono state ancora trattate chirurgicamente e/o con radioterapia. Pazienti con precedente diagnosi e trattamento di metastasi al CNS o compressione del midollo spinale possono essere considerati per lo Studio, se ci sono evidenze che la malattia é clinicamente stabile (SD) per almeno 28 giorni;
    Gravidanza o sospetta gravidanza;
    Non risolta tossicità cronica per precedenti trattamenti anti-cancro che secondo giudizio clinico rendono il paziente non elegibile allo Studio;
    Conosciuta serie ipersensibilità al principio attivo in Studio o a qualunque eccipiente;
    Oltra neoplasia concomitante o diagnosticata negli ultimi 5 anni ad eccezione del basalioma o del cancro alla cervice in situ;
    qualsiasi evidenza di malattia interstiziale polmonare clinicamente attiva;
    qualsiasi evidenza, secondo il giudizio clinico, di severa o incontrollata malattia sistemica;
    qualsiasi cambiamento infiammatorio oculare secondo il giudizio clinico;
    qualsiasi evidenza di altro disturbo clinico o di parametro di laboratorio che rende il paziente non elegibile allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Time to PSF
    Tempo alla PSF
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Time to Overall Survival (OS)
    Tempo di Soppravvivenza Globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately at 26 months follow up
    Approssimativamente a 26 mesi di Follow-up
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA8
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    At the end of participation in the study, it will be proposed to the patient the therapy considered most suitable based on available knowledge.
    Al termine della partecipazione allo studio, sarà proposta al paziente la terapia considerata più adeguata sulla base delle conoscenze disponibili.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IRCCS San Raffaele
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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