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    Summary
    EudraCT Number:2012-000164-25
    Sponsor's Protocol Code Number:MILES-4
    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:2012-03-08
    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 number2012-000164-25
    A.3Full title of the trial
    A factorial study comparing pemetrexed with gemcitabine and testing the efficacy of the addition of cisplatin in elderly patients with non squamous advanced, metastatic or recurrent NSCLC.
    Studio multicentrico randomizzato di fase III, con disegno fattoriale, di valutazione della efficacia di pemetrexed vs. gemcitabina, e della efficacia della aggiunta del cisplatino nel trattamento dei pazienti anziani con carcinoma polmonare non a piccole cellule, ad istotipo non squamoso, in fase avanzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A factorial study comparing pemetrexed with gemcitabine and testing the efficacy of the addition of cisplatin in elderly patients with non squamous advanced, metastatic or recurrent NSCLC.
    Studio multicentrico randomizzato di fase III, con disegno fattoriale, di valutazione della efficacia di pemetrexed vs. gemcitabina, e della efficacia della aggiunta del cisplatino nel trattamento dei pazienti anziani con carcinoma polmonare non a piccole cellule, ad istotipo non squamoso, in fase avanzata
    A.3.2Name or abbreviated title of the trial where available
    MILES-4
    MILES-4
    A.4.1Sponsor's protocol code numberMILES-4
    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 SponsorISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    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 supportEli Lilly Italia S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per lo studio e la Cura dei Tumori - Napoli
    B.5.2Functional name of contact pointSC Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number081 5903 571
    B.5.5Fax number081 770 29 38
    B.5.6E-mailsegreteria@usc-intnapoli.net
    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 ALIMTA*1FL POLV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA SpA
    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.3.4Pharmaceutical form Powder for 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 2
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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.3.4Pharmaceutical form Powder for 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    elderly patients with non squamous advanced, metastatic or recurrent NSCLC
    pazienti anziani con carcinoma polmonare non a piccole cellule, ad istotipo non squamoso, in fase avanzata
    E.1.1.1Medical condition in easily understood language
    elderly patients with non squamous advanced, metastatic or recurrent NSCLC
    pazienti anziani con carcinoma polmonare non a piccole cellule, ad istotipo non squamoso, in fase avanzata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10025038
    E.1.2Term Lung adenocarcinoma stage IV
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10023780
    E.1.2Term Large cell lung cancer stage IV
    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 test whether the addition of cisplatin to single agent chemotherapy (gemcitabine or pemetrexed) prolongs survival as compared to single agent chemotherapy in elderly patients with non squamous NSCLC. To test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.
    Valutare l’efficacia dell’aggiunta del cisplatino alla chemioterapia con agente singolo (gemcitabina o pemetrexed) in termini di prolungamento della sopravvivenza globale, in pazienti anziani con NSCLC ad istotipo non squamoso. Valutare l’efficacia del pemetrexed rispetto alla gemcitabina in termini di prolungamento della sopravvivenza globale, in pazienti anziani con NSCLC ad istotipo non squamoso
    E.2.2Secondary objectives of the trial
    To compare toxicity within each planned comparison. To compare progression-free survival within each planned comparison. To compare response rate within each planned comparison. To compare quality of life within each planned comparison. To conduct exploratory analyses for the identification of prognostic and predictive factors of the efficacy of pemetrexed and cisplatin
    Confrontare la tossicità in ciascuno dei 2 confronti programmati. Confrontare la sopravvivenza libera da progressione in ciascuno dei 2 confronti programmati. Confrontare la risposta obiettiva in ciascuno dei 2 confronti programmati. Confrontare la qualità di vita in ciascuno dei 2 confronti programmati. Condurre analisi esplorative per l’identificazione di fattori prognostici e fattori predittivi dell’efficacia del pemetrexed e del cisplatino.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Diagnosis of cytologically or histologically confirmed non-small cell lung cancer. · Non squamous tumor type (including those with a non-specified tumor type). · Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition. · Both patients at first diagnosis or those with disease recurrence after former surgery are eligible. · At least one target or non-target lesion according to RECIST version 1.1. · Male or female ³ 70 years of age. · ECOG PS 0 or 1. · Life expectancy of > 3 months. · Neutrophils ³ 1.5 x 109/L, platelets ³ 100 x 109/L, and hemoglobin ³ 9 g/dL. · Bilirubin level either normal or < 1.5 x ULN. · AST (SGOT) and ALT (SGPT) £ 2.5 x ULN (£ 5 x ULN if liver metastasis are present). · Serum creatinine < 1.5 x ULN. · Signed written informed consent
    · Diagnosi di NSCLC confermata citologicamente o istologicamente. · Istotipo non squamoso. · Stadio di malattia IV (M1a o M1b) o IIIB (purché con metastasi ai linfonodi sovraclaveari) secondo il sistema di stadi azione TNM VII edizione. · Pazienti di entrambi i sessi. · Età ³70 anni. · Performance status 0-1 secondo ECOG. · Pazienti alla prima diagnosi o con recidiva dopo chirurgia primaria. · Almeno una lesione target o non target secondo i criteri RECIST versione 1.1. · Aspettativa di vita di almeno 3 mesi. · Neutrofili ³ 1.500/mm³, piastrine ³ 100.000/mm³, emoglobina ³9 g/dl. · Creatininemia &lt; 1.5 volte il valore massimo normale. · AST e/o ALT £ 2.5 volte il valore massimo normale o £ 5 volte il valore massimo normale in presenza di metastasi epatiche. · Bilirubinemia £1.5 volte il valore massimo normale. · Consenso informato scritto.
    E.4Principal exclusion criteria
    · Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy. · Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications. · Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA). · Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed). · Known or suspected hypersensitivity to any of the study drugs.
    · Precedente terapia medica antineoplastica per la malattia metastatica. La precedente chirurgia e/o trattamento radiante sono consentiti. NB.: la precedente terapia medica adiuvante è permessa, purché non contenente gemcitabina o pemetrexed e terminata da almeno 6 mesi. · Precedente o concomitante neoplasia maligna (escluso il carcinoma cutaneo baso o spinocellulare, il carcinoma in situ della cervice uterina, purché adeguatamente trattati e il carcinoma della prostata resecato con PSA nella norma) diagnosticata nei 5 anni precedenti alla data di registrazione. · Pazienti con compressione midollare o metastasi cerebrali sintomatiche. (NB.: sono eleggibili i pazienti portatori di metastasi cerebrali o di compressione midollare purché asintomatiche, anche dopo trattamento chirurgico o radiante. La terapia medica con antiedemigeni o antiepilettici, successiva a trattamenti chirurgici o radianti, non costituisce motivo di esclusione). · Presenza di patologie sistemiche non adeguatamente trattate (incluse infezioni attive, patologie significative cardiovascolari o infarto del miocardio nei 12 mesi precedenti, epatiche, renali o metaboliche) che a giudizio del medico rendano non praticabile il trattamento chemioterapico. · Ipersensibilità nota o sospetta ad uno dei farmaci in studio.
    E.5 End points
    E.5.1Primary end point(s)
    overall survival
    sopravvivenza globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 weeks in the treatment; every 12 weeks last treatment
    ogni 3 settimane durante il trattamento; ogni 12 settimane alla fine del trattamento
    E.5.2Secondary end point(s)
    toxicity; progression-free survival; response rate; quality of life.
    tossicità; sopravvivenza libera da progressione; risposta obiettiva; qualità di vita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 3 weeks in the treatment; every 12 weeks last treatment
    ogni 3 settimane durante il trattamento; ogni 12 settimane alla fine del trattamento
    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) 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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 No
    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 years0
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned 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: 0
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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 state550
    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)
    NA
    NA
    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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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