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    Summary
    EudraCT Number:2014-000531-17
    Sponsor's Protocol Code Number:D5160C00002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-000531-17
    A.3Full title of the trial
    A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with EGFRm+/T790M+, Locally Advanced or Metastatic NSCLC who have Progressed Following Prior Therapy with an Approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent.
    Ensayo fase II, abierto, de un solo brazo, para evaluar la seguridad y la eficacia de AZD9291 en pacientes con cáncer de pulmón no microcítico localmente avanzado/metastásico, que ha progresado al tratamiento previo con un inhibidor de la tirosina quinasa del receptor del factor de crecimiento epidérmico y es positivo para la mutación del receptor del factor de crecimiento epidérmico y para la mutación T790M (AURA2)?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate safety and efficacy of AZD9291 when given orally to patients with EGFRm+/T790M+ non small cell lung cancer. Patients will be chosen from those who have already been prescribed an EGRf TKI medicine (such as Iressa or Tarceva)
    A.3.2Name or abbreviated title of the trial where available
    AURA-2
    AURA-2
    A.4.1Sponsor's protocol code numberD5160C00002
    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.1.3.4CountrySweden
    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.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmaceutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigacion Clinica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Ed Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 No
    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 nameAZD9291 40 mg film-coated tablet
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form 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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 No
    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 nameAZD9291 80 mg film-coated tablet
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form 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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Non Small Cell Lung Cancer
    Cancer de pulmon no microcitico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cancer de pulmon
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 assess the efficacy of AZD9291 by assessment of Objective Response Rate (ORR)
    Evaluar la eficacia de AZD9291 mediante la evaluación de la tasa de respuestas objetivas (TRO).
    E.2.2Secondary objectives of the trial
    To further assess the efficacy of AZD9291 in terms of:
    - Progression Free Survival (PFS)
    - Duration of Response (DoR)
    - Disease Control Rate (DCR)
    - Tumour shrinkage
    - Overall Survival (OS)
    To assess the safety and tolerability profile of AZD9291.
    To investigate the effect of AZD9291 on QTc interval after oral dosing to NSCLC patients.
    To assess the impact of AZD9291 on patients? disease-related symptoms and health related quality of life (HRQoL).
    To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550).
    Evaluar en más detalle la eficacia de AZD9291 en términos de:
    - Supervivencia libre de progresión (SLP)
    - Duración de la respuesta (DdR)
    - Tasa de control de la enfermedad (TCE)
    - Reducción del tamaño tumoral
    - Supervivencia global (SG)
    Evaluar el perfil de seguridad y tolerabilidad de AZD9291.
    Investigar el efecto de AZD9291 sobre el intervalo QTc después de la administración oral a pacientes con CPNM.
    Evaluar el impacto de AZD9291 sobre los síntomas relacionados con la enfermedad y la calidad de vida relacionada con la salud (CdVRS) de los pacientes.
    Caracterizar la farmacocinética (FC) de AZD9291 y sus metabolitos (AZ5104 y AZ7550).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Locally advanced/metastatic NSCLC.
    Radiological documentation of disease progression following 1st line EGFR TKI treatment or following minimum prior therapy with an EGFR TKI and platinum-containing doublet chemotherapy.
    Confirmation the tumour harbours EGFR and T790 mutation.
    WHO status 0-1; min life expectancy of 12 weeks.
    At least one measurable lesion at baseline by CT/MRI.
    Females of child-bearing potential using contraception; negative pregnancy test.
    CPNM localmente avanzado o metastásico.
    Documentación radiológica de progresión de la enfermedad
    después del tratamiento de primera línea con TKI del EGFR pero que no hayan recibido más tratamiento O después de tratamiento previo con un TKI del EGFR y una quimioterapia en doblete basada en platino. Los pacientes pueden haber recibido también líneas adicionales de tratamiento. Todos los pacientes deben tener progresión radiológica documentada durante con el último tratamiento administrado antes de ser incluidos en el ensayo.
    Confirmación de que el tumor alberga una mutación de EGFR que se sabe que se asocia a sensibilidad a TKI del EGFR.
    Estado funcional de la Organización Mundial de la Salud (OMS) 0-1 sin deterioro en las 2 semanas previas y una esperanza de vida mínima de 12 semanas.
    Al menos una lesión, que pueda medirse con exactitud en el momento basal con tomografía computarizada (TC) o resonancia magnética (RM).
    Las mujeres deben estar usando métodos anticonceptivos adecuados,
    y deben tener una prueba de embarazo negativa.
    E.4Principal exclusion criteria
    Treatment with an EGFR-TKI within 8 days of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 (or 3rd generation TKIs); major surgery within 4 weeks; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks; current treatment with potent inhibitors of CYP2C8 and potent inhibitors/inducers of CYP3A4.
    Unresolved toxicities from prior therapy.
    Unstable spinal cord compression/brain metastases.
    Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
    Refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection.
    Cardiac disease.
    Past history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
    Inadequate bone marrow reserve or organ function.
    Tratamiento con un TKI del EGFR en el plazo de 8 días previos a la primera dosis del tratamiento del ensayo.
    Cualquier quimioterapia citotóxica, agentes experimentales u otros fármacos contra el cáncer de dentro de los 14 días previos a la primera dosis del tratamiento del ensayo.
    Tratamiento previo con AZD9291 o TKI del EGFR de tercera generación.
    Cirugía mayor dentro del plazo de 4 semanas antes de la primera dosis del tratamiento del ensayo.
    Tratamiento con radioterapia a más del 30% de la médula ósea o con un campo de radiación amplio dentro de las 4 semanas previas a la primera dosis del tratamiento del ensayo.
    Pacientes que reciben actualmente inhibidores potentes de CYP2C8 e inhibidores o inductores potentes de CYP3A4
    Cualquier toxicidad no resuelta del tratamiento previo
    Compresión de la médula espinal o metástasis cerebrales.
    Cualquier prueba de enfermedades sistémicas graves o no controladas, incluidas hipertensión no controlada y diátesis hemorrágica activa, o infección activa.
    Náuseas y vómitos refractarios, enfermedades gastrointestinales crónicas o resección intestinal.
    Enfermedad Cardiaca.
    Antecedentes médicos de enfermedad pulmonar intersticial, enfermedad pulmonar intersticial inducida por fármacos, neumonitis por irradiación que precisó tratamiento con esteroides o cualquier prueba de enfermedad pulmonar intersticial clínicamente activa.
    Reserva insuficiente en la médula ósea o de la función de órganos.
    E.5 End points
    E.5.1Primary end point(s)
    ORR according to RECIST 1.1 by an Independent Central Review (ICR).
    Sensitivity analysis of ORR using investigators assessments of RECIST.
    TRO de acuerdo con los RECIST 1.1 por una Revisión Central Independiente (RCI). Análisis de sensibilidad de la TRO usando evaluaciones de los RECIST por parte del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks relative to first dose until disease progression
    Cada 6 semanas en relacion con la primera dosis hasta la progresion de la enfermedad
    E.5.2Secondary end point(s)
    PFS, DoR, DCR according to RECIST 1.1 using assessments performed by an ICR.
    Sensitivity analysis of PFS, DoR, DCR, tumour shrinkage using investigators assessments of RECIST.
    Description of OS.
    Adverse events (graded by CTCAE v4)
    - Clinical chemistry, haematology and urinalysis
    - Vital signs, Physical Examination, Weight
    - Digital ECG
    - WHO Performance Status
    QT interval by digital ECG
    EORTC QLQ-C30
    EORTC QLQ LC13
    PK exposure parameters: (Cmax) (Css max), (tmax),(tss max), (AUC(0-24)),(AUCss), (Css min), (CLss/F) (RAC)
    The ratio of metabolite to AZD9291 will also be calculated.
    SLP, DdR, TCE y reducción del tamaño tumoral de acuerdo con los RECIST 1.1 usando evaluaciones realizadas por una RCI.
    Análisis de sensibilidad de la SLP, la DdR, la TCE, y la reducción del tamaño tumoral, usando evaluaciones de los RECIST por los investigadores.
    Descripción de la SG.
    - Acontecimientos adversos (clasificados por grados según los CTCAE v4)
    - Bioquímica, hematología y análisis de orina
    - Constantes vitales, exploración física, peso
    - ECG digital
    - Estado funcional de la OMS
    - Ecocardiograma/MUGA (para FEVI)
    Intervalo QTc mediante ECG digital
    QLQ-C30 de la EORTC:
    QLQ-LC13 de la EORTC
    Parámetros de exposición FC: (Cmax) (Css max), (tmax),(tss max), (AUC(0-24)),(AUCss), (Css min), (CLss/F) (RAC)
    Se calculará también el cociente de metabolito a AZD9291.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy every 6 weeks, Safety and Health related quality of life throughout study, PK exposure Cycles 1 to 3.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory Assesments
    Evaluaciones exploratorias
    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 No
    E.8.1.1Randomised No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA11
    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
    Canada
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Spain
    Taiwan
    United States
    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
    the last visit of the last subject undergoing the study
    la última visita del último paciente sometido al ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 175
    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)
    Patients may continue to receive AZD9291 as long as they are continuing to show clinical benefit, as judged by the investigator, and in the absence of discontinuation criteria.
    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 Decision2014-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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