Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2011-004942-16
    Sponsor's Protocol Code Number:D791LC00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-23
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    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.
    Ensayo fase III aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, multicéntrico, para evaluar la eficacia y la seguridad de continuar el tratamiento con IRESSA® 250 mg además de quimioterapia frente a quimioterapia sola en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico, positivo para mutación del receptor del factor de crecimiento epidérmico (EGFR), que han progresado con IRESSA® en primera línea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phaseIII study of IRESSA treatment beyond progression in addition to Chemotherapy versus Chemotherapy alone
    Un estudio en fase III de tratamiento con IRESSA más allá de la progresión, además de la quimioterapia versus quimioterapia sola
    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 AB
    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 supportAstraZenecaAB
    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 Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.4Telephone numbern/a
    B.5.5Fax numbern/a
    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 AuthorisationEuropean Union
    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 nameGefitinib
    D.3.2Product code AZD1839
    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
    Células no pequeñas de cáncer de pulmón
    E.1.1.1Medical condition in easily understood language
    Non Small Cell Lung Cancer
    Células no pequeñas de cáncer de pulmón
    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
    Evaluar la supervivencia libre de progresión (SLP) en pacientes que tienen ?resistencia adquirida? a gefitinib en primera línea, comparando la continuación con gefitinib además de la combinación de quimioterapia con cisplatino más pemetrexed frente a la combinación de quimioterapia con cisplatino más pemetrexed por sí sola.
    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 the safety and tolerability in patients
    1. Evaluar la supervivencia global (SG)
    2. Evaluar la tasa de respuestas objetivas (TRO) y la tasa de control de la enfermedad (TCE)
    3. Evaluar los síntomas y la calidad de vida relacionada con la salud (CdVRS) medida mediante el cuestionario Evaluación Funcional del Tratamiento del Cáncer ? Cáncer de pulmón (FACT-L)
    4. Evaluar la seguridad y tolerabilidad en pacientes que tienen ?resistencia adquirida? a gefitinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)-Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 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. Firma del consentimiento informado con anterioridad a la realización de cualquiera de los procedimientos específicos del estudio
    2. Pacientes varones o mujeres de 18 años o más.
    3. Confirmación citológica o histológica de CPNM de histología distinta de predominantemente epidermoide con una mutación de la TK del EGFR determinada localmente.
    4. ?Resistencia adquirida? con gefitinib en primera línea, definida por los siguientes criterios de valoración clínicos:
    5. Performance status de la OMS 0, 1.
    6. Esperanza de vida de 12 semanas o más.
    7. Pacientes adecuados para comenzar doblete de quimioterapia con cisplatino y pemetrexed.
    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. Implicación en la planificación y/o realización del estudio (aplicable al personal de AstraZeneca y/o al personal del centro del estudio).
    2. Inclusión o aleatorización previa en el presente estudio
    3. Quimioterapia u otro tratamiento anticanceroso sistémico previo (excepto gefitinib). La radioterapia paliativa debe terminarse al menos 4 semanas antes del comienzo del tratamiento del estudio, sin que persista toxicidad por la radiación.
    4. Antecedentes de enfermedad pulmonar intersticial, enfermedad intersticial inducida por fármacos, neumonitis por irradiación que precisó tratamiento con esteroides o cualquier prueba de enfermedad pulmonar intersticial activa.
    5. Neutrófilos <1,5 x 109/l o plaquetas <100 x 109/l.
    6. Bilirrubina sérica >1,5 x límite superior de la normalidad (LSN).
    7. Aclaramiento de creatinina <45 ml/min calculado por el método de Cockcroft ?Gault, recogida de orina de 24 horas, estudio EDTA u otro método validado.
    8. Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >2,5 x LSN en ausencia de metástasis hepáticas o >5 x LSN en presencia de metástasis hepáticas.
    9. A criterio del investigador, cualquier prueba de enfermedad sistémica grave o no controlada (p. ej., enfermedad respiratoria, cardíaca, renal o hepática inestable o descompensada).
    10. El tratamiento con un fármaco en investigación dentro de las 4 semanas antes de la aleatorización (se permite el gefitinib en primera línea recibido a través de un estudio clínico u otro programa de acceso).
    11. Otros tumores malignos coexistentes o tumores malignos diagnosticados dentro de los últimos 5 años, a excepción de carcinoma basocelular o cáncer de cuello uterino in situ o cáncer gástrico intramucoso resecado de forma completa.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Supervivencia libre de Progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    for the study: until 190 PFS events
    Para el estudio: Hasta 190 acontecimientos de SLP
    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
    ? Supervivencia global (SG).
    ? Tasa de respuesta objetiva (TRO).
    ? Tasa de control de la enfermedad (TCE).
    ? Síntomas y CdVRS medida por el Índice de Resultado del Ensayo del FACT-L (TOI).
    ? Seguridad y tolerabilidad en pacientes que tienen "resistencia adquirida" a gefitinib.
    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) Para el estudio: Hasta 125 acontecimientos de SG
    2) Los datos obtenidos hasta la progresión o la última valoración evaluable en ausencia de progresión
    3) Cada 6 semanas en relación con la aleatorización
    4) Desde la aleatorización hasta la progresión documentada
    5) 30 días después de la última dosis del fármaco del estudio
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned6
    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
    The end of the study is defined as the data cut-off, which will be approximately at 11months
    after the last patient has started study treatment. It is expected that this length of follow-up
    will be sufficient to achieve 190 PFS events and approximately 125 OS events. An analysis at
    70% OS events will be completed approximately 12 months after the primary analysis.
    El final del estudio se define como el corte de los datos, que será aproximadamente a los 11 meses después de que el último paciente haya comenzado el tratamiento del estudio. Se espera que esta duración del seguimiento sea suficiente para alcanzar 190 acontecimientos de SLP y aproximadamente 125 acontecimientos de SG. Se realizará un análisis en el 70% de los acontecimientos de SG aproximadamente 12 meses después del análisis principal.
    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.1.1.1In 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 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 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)
    Standard of Care
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-20
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands