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    EudraCT Number:2011-004942-16
    Sponsor's Protocol Code Number:D791LC00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004942-16
    A.3Full title of the trial
    A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSATM 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSATM.
    Studio di Fase III, randomizzato, in doppio cieco, controllato verso placebo, multicentrico, a gruppi paralleli per valutare l'efficacia e la sicurezza della prosecuzione della terapia con IRESSATM 250 mg come terapia aggiuntiva alla chemioterapia, confrontata con la sola chemioterapia in pazienti con Tumore Polmonare Non a Piccole Cellule (NSCLC) localmente avanzato o metastatico positivo alla mutazione del Recettore per il Fattore di Crescita Epidermico (EGFR) in progressione di malattia al trattamento di prima linea con IRESSATM.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III study of IRESSA treatment beyond progression in addition to Chemotherapy versus Chemotherapy alone
    Uno studio di fase III che studia l'utilizzo di IRESSA nella prosecuzione della terapia come terapia aggiuntiva alla chemioterapia, confrontata con la sola chemioterapia
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD791LC00001
    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 SponsorASTRAZENECA
    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 supportASTRAZENECA AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressInformation Centre
    B.5.3.2Town/ cityInformation Centre
    B.5.3.3Post code20080
    B.5.4Telephone number029801 1
    B.5.5Fax number029801 1
    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. name IRESSA
    D. of the Marketing Authorisation holderAstraZenecaAB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Film-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 INNGEFITINIB
    D.3.9.1CAS number 184475-35-2
    D.3.9.2Current sponsor codeAZD1839
    D.3.9.4EV Substance CodeSUB20637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non Small Cell Lung Cancer
    Tumore polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non Small Cell Lung Cancer
    Tumore polmonare non a piccole cellule
    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 LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    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 evaluate Progression Free Survival (PFS) in patients who have ''acquired resistance'' to first line gefitinib
    L’obiettivo primario dello studio è valutare la sopravvivenza libera da progressione (PFS) in pazienti che hanno acquisito resistenza al trattamento di prima linea con gefitinib.
    E.2.2Secondary objectives of the trial
    1. To evaluate overall survival (OS) 2. To evaluate Objective Response Rate (ORR) and Disease Control Rate (DCR) 3. To evaluate symptoms and Health related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire 4. To evaluate gefitinib safety and tolerability.
    • Valutare la sopravvivenza globale (OS) in pazienti che hanno acquisito resistenza al trattamento con gefitinib
    • Valutare il tasso di risposta obiettiva (ORR) e il tasso di controllo della malattia (DCR)
    • Valutare i sintomi e la qualità della vita correlata alla salute (Health Related Quality of Life HRQOL) mediante i questionari FACT-L (Functional Assessment of Cancer Therapy for Lung Cancer)
    • Valutare sicurezza e tollerabilità di gefitinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)-Male or female patients aged 18 years or older 2)-Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally 3)-Patients with documented 'acquired resistance' on first line gefitinib 4)-Patients suitable to start cisplatin based pemetrexed combination chemotherapy. 5)-Provision of informed consent prior to any study specific procedures.
    1)Soggetti di sesso femminile o maschile di almeno 18 anni di età.
    2)Conferma citologica o istologica di carcinoma polmonare non a piccole cellule (NSCLC) ad eccezione dell’istologia predominantemente squamosa, con una mutazione attivante del recettore tirosin-chinasico del fattore di crescita epidermico (EGFR TK) ottenuta tramite esame eseguito localmente.
    3) “Resistenza acquisita” ad una prima linea di trattamento con gefitinib, come da definizioni nel protocollo.
    4) Pazienti idonei ad iniziare chemioterapia combinata con cisplatino e pemetrexed.
    5) Consenso informato firmato e datato dal paziente prima di qualsiasi procedura studio specifica.
    E.4Principal exclusion criteria
    1)-Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). 2)-Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease 3)-Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer 4)-Any evidence of severe of uncontrolled systemic disease 5)-Treatment with an investigational drug within 4 weeks before randomization
    1)Precedente chemioterapia o altre terapie anti-neoplastiche sistemiche (escluso gefitinib)
    2) Storia medica di malattia interstiziale polmonare, malattia interstiziale farmaco-indotta, polmonite da radiazioni che richieda trattamento steroideo o qualsiasi evidenza di malattia interstiziale polmonare clinicamente attiva.
    3) Altre neoplasie maligne co-esistenti o neoplasie maligne diagnosticate nell’arco degli ultimi 5 anni, con l’eccezione di carcinoma a cellule basali o cancro cervicale in situ o cancro intramucosale gastrico completamente asportato.
    4)A giudizio del ricercatore, qualunque evidenza di malattia sistemica grave non controllata (es. malattia respiratoria, cardiaca, renale o epatica, instabile o non compensata).
    5) 10. Trattamento con un farmaco sperimentale nelle 4 settimane precedenti la randomizzazione (è concessa la somministrazione di un trattamento di prima linea con gefitinib mediante uno studio clinico o un altro programma di accesso).
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    for the study: until 190 PFS events
    fino a 190 eventi PFS
    E.5.2Secondary end point(s)
    1) Overall survival (OS) 2) Object Response Rate (ORR) 3) Disease Control Rate (DCR) 4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) 5) Safety and tolerability
    1) Sopravvivenza globale (OS)
    2) Tasso di risposta obiettiva (ORR)
    3) Tasso di controllo della malattia (DCR)
    4) Sintomi e la qualità della vita correlata alla salute (Health Related Quality of Life HRQOL) mediante i questionari FACT-L (Functional Assessment of Cancer Therapy for Lung Cancer)
    5) Sicurezza e tollerabilità
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) for the study: until 125 OS events 2) until progression or last evaluable assessment in absence of progression 3) until 6 weeks following progression 4) from randomization until treatment discontinuation 5) from consent to 30 days after discontinuation of study treatment
    1) per lo studio: fino a 125 eventi OS 2) fino a preogressione o all'ultimo assesment valutabile in assenza di progressione di malattia
    3) fino a 6 settimane successive a progressione
    4) dalla randomizzazione fino alla discontinuazione dle trattamento
    5) dal comsemso a 30 gg dopo la discontinuazione 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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. 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 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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    Russian Federation
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1Number 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) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 250
    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)
    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 Decision2012-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-20
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