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    Summary
    EudraCT Number:2012-001194-81
    Sponsor's Protocol Code Number:EPIC
    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:2012-03-29
    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 number2012-001194-81
    A.3Full title of the trial
    Randomized Phase III Multicenter Trial of Customized Chemotherapy versus Standard of Care for 1st Line Treatment of Elderly Patients with Advanced Non-Small-Cell Lung Cancer
    Studio multicentrico, randomizzato, di fase III, di confronto fra la chemioterapia di I linea personalizzata e la chemioterapia standard in pazienti anziani affetti da carcinoma polmonare non a piccole cellule in stadio avanzato/metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study that compares a standard chemioterapic treatment for non-small cell lung cancer to a treatment that is based on the genetic make-up of your tumour
    Studio clinico che consiste nel confrontare un trattamento standard di chemioterapia per il carcinoma polmonare non a piccole cellule con un trattamento basato sul profilo genetico del tumore.
    A.3.2Name or abbreviated title of the trial where available
    EPIC
    EPIC
    A.4.1Sponsor's protocol code numberEPIC
    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 SponsorAZIENDA OSPEDALIERA S. LUIGI GONZAGA
    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 supportUNIVERSITA' DEGLI STUDI DI TORINO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' DEGLI STUDI DI TORINO
    B.5.2Functional name of contact pointS.C.D.U. ONCOLOGIA POLMONARE
    B.5.3 Address:
    B.5.3.1Street AddressREGIONE GONZOLE 10
    B.5.3.2Town/ cityORBASSANO (TO)
    B.5.3.3Post code10043
    B.5.3.4CountryItaly
    B.5.4Telephone number011 9026978
    B.5.5Fax number011 9038616
    B.5.6E-mailfrancesca.arizio@unito.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 CARBOPLATINO TEVA*1FL 600MG/60
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA Srl
    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 Concentrate 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.3.9.2Current sponsor codecarboplatino
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number600
    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.2.1.1.1Trade name DOCETAXEL ACT*INF 1ML 20MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS ITALY 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 Concentrate 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 codedocetaxel
    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 typeup to
    D.3.10.3Concentration number75
    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 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 GEMCITABINA HOS.IT*INF FL 2G
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA ITALIA Srl
    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 Concentrate 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 codegemcitabina
    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 typeup to
    D.3.10.3Concentration number1000
    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: 4
    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 Concentrate 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 codealimta
    D.3.9.3Other descriptive namealimta
    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 typeup to
    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: 5
    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 NAVELBINA*IV 50MG 5ML
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE 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 Concentrate 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 codenavelbina
    D.3.9.3Other descriptive namenavelbine
    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 typeup to
    D.3.10.3Concentration number30
    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 Advanced Non-Small-Cell Lung Cancer
    Pazienti anziani affetti da carcinoma polmonare non a piccole cellule in stadio avanzato/metastatico.
    E.1.1.1Medical condition in easily understood language
    Elderly Patients with Advanced Non-Small-Cell Lung Cancer
    Pazienti anziani con tumore del polmone metastatico
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    The primary endpoint is OS (determined from the date of randomization).
    • Mettere a confronto la sopravvivenza globale fra soggetti anziani con carcinoma polmonare non a piccole cellule (NSCLC) in stadio avanzato/metastatico sottoposti a chemioterapia di I linea personalizzata sulla base del profilo genetico del tumore primario, definito per mezzo della reazione a catena della polimerasi quantitativa in tempo reale (qRT-PCR) su campioni in paraffina, e soggetti anziani sottoposti a chemioterapia standard di I linea nella modalità stabilita dal ricercatore.
    E.2.2Secondary objectives of the trial
    a) PFS at 6 months (determined from the date of randomization).
    b) Treatment response (according to RECIST 1.1).
    c)To determine the feasibility of treatment selection based on pharmacogenomic parameters in previously untreated patients with advanced NSCLC in a multi-institutional randomized setting.
    d)To describe the toxicity in patients treated with and without assignment of chemotherapy based on gene expression.
    •Mettere a confronto la percentuale di sopravvivenza libera da progressione fra soggetti anziani affetti da NSCLC in stadio avanzato/metastatico sottoposti a chemioterapia di I linea personalizzata sulla base del profilo genetico del tumore primario e soggetti anziani sottoposti a chemioterapia standard di I linea nella modalità stabilita dal ricercatore.
    •Valutare la risposta al trattamento
    •Valutare la fattibilità del trattamento di I linea la cui scelta è basata su criteri di farmacogenomica.
    •Valutare la tossicità del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically confirmed NSCLC of adenocarcinoma, squamous cell carcinoma, large cell [53][68] carcinoma, or NSCLC not otherwise specified (NOS). For the purposes of this trial all patients that are not categorically called as squamous cell carcinoma will be referred to as non-squamous NSCLC. Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to obtain both the diagnostic and molecular analysis-required specimen during the same procedure.
    4.1.2 Willing to undergo a biopsy to enable precise histologic determination and customization of chemotherapy if necessary
    4.1.3 Stage IV NSCLC by the AJCC Staging Manual 7th edition (2010)
    4.1.4 Measurable or evaluable disease by RECIST 1.1[53][68]
    4.1.5 Age  70 years
    4.1.6 Performance Status 0 or 1 (by ECOG criteria)
    4.1.7 Adequate bone marrow function as evidenced by the following (assessed within 21 days of study registration ):
    Absolute neutrophil count > 1,500/mm3
    Platelet count  100,000/mm3
    Hemoglobin > 9.0 gm/dL
    4.1.8 Normal prothrombin time (PT) and activated prothrombin time with thromboplastin and kaolin (APTT)
    4.1.9 Serum creatinine  1.5 x UNL (assessed within 21 days of study registration)
    4.1.10 Adequate liver function as evidenced by the following (assessed within 21 days of study registration):
    Total bilirubin must be within normal limits
    AST (SGOT) and ALT (SGPT)  2.5 x UNL
    Alkaline Phosphatase  4 x UNL
    4.1.11 Serum calcium  1.1 x UNL
    4.1.12 Signed informed consent document (ICD)
    4.1.13 Men with partners in the childbearing age group must use effective contraception while on treatment and for 6 months thereafter.
    4.1.14 Previous surgery for NSCLC (more than 30 days before study registration) is allowed but 4.1.3 and 4.1.4 must be present
    4.1.15 Previous radiotherapy is allowed if:
    (i) The time between completion of RT and initiation of study treatment is at least 7 days,
    (ii) The patient has fully recovered from all toxic effects, and
    (iii) At least one target lesion or evaluable disease is outside the radiation field.
    4.1.16 Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a curative intent surgical resection for a NSCLC. Patient should be previously untreated for metastatic disease.
    4.1.17 Patients with stable brain metastases will be allowed to enroll. At the time of screening, a CT scan or MRI of the brain is only required if clinically indicated. Stable brain metastasis is defined as no progression of brain metastases 14 days after conclusion of definitive treatment as documented by a CT scan or MRI of the brain.
    Tutti i pazienti devono presentare evidenza istologica di carcinoma polmonare non a piccole cellule di stadio avanzato/metastatico (classificato come tale in base ai parametri sanciti dall'American Joint Committee on Cancer Staging Manual [AJCC], 7a edizione, 2010) ed avere materiale biologico sufficiente per le analisi molecolari o accettare l’esecuzione di un ulteriore esame diagnostico per il reperimento del tessuto. I pazienti devono essere di età ≥ ai 70anni; devono avere performance status secondo la scala ECOG pari a 0-1 e sottoscrivere di propria volontà un consenso informato. Devono avere almeno una lesione misurabile secondo i criteri RECIST 1.1. ed adeguata funzione d’organo. E’ concessa una precedente chirurgia per il tumore polmonare (se eseguita più di 30 giorni prima dell’entrata nello studio) e una chemioterapia sistemica con intento adiuvante o neoadiuvante se conclusa almeno 12 mesi prima dall’inserimento in protocollo; o radioterapia se completata almeno 7 giorni prima dall’inizio della chemioterapia. I pazienti con metastasi cerebrali stabili (definite come assenza di progressione 14 giorni dopo la conclusione di un trattamento locale documentato da TC o RM dell’encefalo) possono essere inclusi in protocollo. L’analisi mutazionale di EGFr è mandatoria: i pazienti positivi alla mutazione dell’ esone 20 (T790M, D770) di EGFr, in assenza di mutazioni degli esoni 18,19 o 21 o che abbiano stato mutazionale di EGFr non codificabile possono essere inclusi nel protocollo.
    E.4Principal exclusion criteria
    4.2.1 Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
    4.2.2 Prior malignancies, except:
    Cured non-melanoma skin cancer,
    Curatively treated in situ carcinoma of the cervix, or
    Any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years.
    4.2.3 Presence of uncontrolled brain or leptomeningeal metastases.
    4.2.4 Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v4.0 except if due to trauma
    4.2.5 Other serious illness or medical condition, including but not limited to:
    Congestive heart failure;
    Myocardial infarction within 6 months;
    Significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician or study chair;
    Infection requiring I.V. antibiotics;
    Tuberculosis with ongoing therapy at study entry,
    Superior vena cava syndrome, except if controlled with radiation (see 4.1.15);
    Active peptic ulcer disease;
    Unstable diabetes mellitus;
    Any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease.
    4.2.6 Hypercalcemia requiring therapeutic intervention (see 4.1.11).
    4.2.7 Clinically significant ascites and/or pericardial effusion.
    4.2.8 Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
    4.2.9 Concurrent treatment with other investigational drugs.
    4.2.10 Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol.
    4.2.11 Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded. Please see section 5.3.2 for details regarding adequate tissue samples sizes. Sites will be notified if there is insufficient tissue to conduct the molecular analysis.
    4.2.12 Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.
    sono esclusi i pazienti che hanno sofferto di patologie oncologiche precedenti, fatta eccezione per i carcinomi cutanei non-melanoma, i carcinomi in situ della cervice o altre forme tumorali dalle quali il paziente dovrà, tuttavia, risultare libero da almeno 2 anni prima dell'arruolamento, nonché i pazienti affetti da metastasi cerebrali o leptomeningee non controllate. Non sono ammessi, inoltre, i pazienti che soffrano di neuropatia periferica o di disturbi dell’udito ≥ grado II, definiti come tali secondo i comuni criteri di tossicità (classificati sulla base dei criteri di tossicità per gli eventi avversi, versione 4.0, stabiliti dal National Cancer Institute - CTCAE v. 4.0), di disturbi cardiaci gravi quali infarto miocardico occorso nell'arco degli ultimi 6 mesi, scompenso cardiaco, diabete mellito non controllato, disturbi psichiatrici e neurologici gravi, sindrome della vena cava non radio trattata, ulcera peptica in fase attiva, infezioni in fase attiva o tubercolosi in trattamento, epatite, herpes simplex o herpes zoster che controindichino l’utilizzo di corticosteroidi ad alte dosi, ipercalcemia maligna, soffusione pericardica o versamento ascitico clinicamente significativi. Sono esclusi i pazienti con una storia di grave ipersensibilità a Docetaxel o ai prodotti contenenti Polisorbato 80.
    I pazienti positivi alla mutazione di EGFr negli esoni 18,19 o 21 saranno esclusi dallo studio.
    I pazienti con traslocazione di ALK saranno esclusi dal protocollo, tuttavia l’analisi non è mandatoria
    I pazienti con materiale biologico inadeguato o insufficiente per eseguire le analisi molecolari saranno esclusi dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is OS (determined from the date of randomization).
    Sopravvivenza totale (definita come l'intervallo che intercorre fra la data della randomizzazione e la data del decesso).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 60 months
    Approssimativamente 60 mesi
    E.5.2Secondary end point(s)
    a) PFS at 6 months (determined from the date of randomization).
    b) Treatment response (according to RECIST 1.1).
    2.2.1 To determine the feasibility of treatment selection based on pharmacogenomic parameters.
    2.2.2 To describe the toxicity in patients treated with and without assignment of chemotherapy based on gene expression.
    Sopravvivenza libera da progressione (definita come l'intervallo che intercorre fra la data della randomizzazione e la data del primo insuccesso terapeutico [progressione o decesso]).
    Tasso di risposte (valutato secondo criteri RECIST 1.1.).
    Fattibilità del trattamento di I linea la cui scelta è basata su criteri di farmacogenomica e dunque sull’esecuzione di biopsie tumorali il cui materiale sia disponibile per le analisi molecolari.
    Tossicità (classificata sulla base dei CTCAE v. 4.0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 60 months
    Approssimativamente 60 mesi
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned18
    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
    death of the last patient in follow up phase
    decesso dell'ultimo paziente in follow up
    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: 453
    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 state453
    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)
    follow up
    second line therapy
    supportive care/palliative care
    controlli periodici
    terapie di seconda linea
    terapie di supporto/cure palliative
    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 Decision2012-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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