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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

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    Summary
    EudraCT Number:2014-002694-11
    Sponsor's Protocol Code Number:D5160C00007
    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:2014-10-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002694-11
    A.3Full title of the trial
    A phase III, double-blind, randomised study to assess the efficacy and safety of AZD9291 versus a standard of care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as first-line treatment in patients with Epidermal Growth Factor Receptor Mutation Positive, locally advanced or Metastatic Non-Small Cell Lung Cancer
    Estudio de Fase III, aleatorizado y en doble ciego, para evaluar la seguridad y la eficacia de AZD9291 frente a un inhibidor establecido de la tirosina cinasa del receptor del factor de crecimiento epidérmico como tratamiento de primera línea en el cáncer de pulmón no microcítico, localmente avanzado o metastático, con mutación del receptor del factor de crecimiento epidérmico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of AZD9291 versus Gefitinib or Erlotinib in patients with locally advanced or metastatic Non-Small Cell Lung Cancer
    Ensayo clínico en fase tardía para investigar la eficacia y seguridad de AZD9291 frente a gefitinib o erlotinib en pacientes con cáncer de pulmón no microcítico, localmente avanzado o metastático
    A.3.2Name or abbreviated title of the trial where available
    FLAURA
    A.4.1Sponsor's protocol code numberD5160C00007
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1160-2242
    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
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@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 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 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 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 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.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.2.1.1.1Trade name Iressa 250 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameIressa 250 mg film-coated tablet
    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.3.9.3Other descriptive nameGEFITINIB
    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.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 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.2.1.1.1Trade name Tarceva 100 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameTarceva 100 mg film-coated tablet
    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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeERLOTINIB HYDROCHLORIDE
    D.3.9.3Other descriptive nameERLOTINIB HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.2.1.1.1Trade name Tarceva 150 mg film-coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameTarceva 150 mg film-coated tablet
    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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeErlotinib hydrochloride
    D.3.9.3Other descriptive nameErlotinib hydrochloride
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    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
    D.8 Placebo: 5
    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
    Locally advanced or metastatic non-small cell lung cancer, not amenable to curative surgery or radiotherapy
    Cáncer de pulmón no microcítico, localmente avanzado o metastático, no susceptible de cirugía o radioterapia curativas
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "non-small cell lung cancer" (NSCLC)
    Cancer de pulmón específico "cáncer de pulmón no microcítico"(CPNM)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell 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 assess the efficacy of single agent AZD9291 compared with standard of care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) therapy as measured by progression free survival (PFS)
    Evaluar la eficacia de la monoterapia con AZD9291 en comparación con un ITC establecido del EGFR, en su medición mediante la supervivencia sin progresión (SSP)
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of AZD9291 compared with SoC EGFR-TKI therapy by assessment of PFS in patients with:
    - Positive (or negative) pre-treatment T790M (amino acid substitution at position 790 in EGFR, from a threonine to a methionine) mutation.
    - EGFR Ex19del or L858R mutation.
    - EGFRm+ (Ex19del or L858R) detectable in plasma-derived circulating tumour deoxyribonucleic acid (ctDNA).
    2) To further assess the efficacy of AZD9291 compared with SoC EGFR-TKI therapy by ORR, DoR, DCR, Depth of response and Overall survival (OS)
    3) To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550).
    4) To assess the impact of AZD9291 compared to SoC EGFR-TKI therapy on patients´ disease-related symptoms and Health Related Quality of Life (HRQoL).
    5) To assess patient satisfaction with treatment when receiving AZD9291 compared with SoC EGFR-TKI therapy.
    6) To assess the safety and tolerability profile of AZD9291 compared with SoC EGFR-TKI therapy.
    1)Evaluar eficacia del tratamiento con AZD9291 comparado con un ITC establecido del EGFR, por medición de la SSP en pacientes con:
    - Mutación T790M (sustitución del aminoácido en posición 790 en el EGFR, de una treonina a una metionina) positiva (o negativa) en el pretratamiento.
    -Mutación Ex19del o L858R del EGFR.
    -EGFRm+ (Ex19del o L858R) detectable en ADNtc obtenido en plasma.
    2)Evaluar adicionalmente la eficacia del tratamiento con AZD9291 comparado con un ITC establecido del EGFR.
    3)Caracterizar la FC de AZD9291 y sus metabolitos (AZ5104 y AZ7550)
    4)Evaluar el impacto del tratamiento con AZD9291 comparado con un ITC establecido del EGFR sobre los síntomas de la enfermedad y la calidad de vida relacionada con la salud de los pacientes
    5)Evaluar la satisfacción de los pacientes con el tratamiento con AZD9291 comparado con un ITC establecido del EGFR
    6)Evaluar el perfil de seguridad y de tolerabilidad del tratamiento con AZD9291 en comparado con un ITC establecido del EGFR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged at least 18 years.
    2. Pathologically confirmed adenocarcinoma of the lung.
    3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
    4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
    5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
    6. Patients must be treatment-naïve for advanced NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre.
    1. Hombre o mujer, de como mínimo 18 años de edad.
    2. Adenocarcinoma de pulmón confirmado histológicamente.
    3. CPNM localmente avanzado o metastásico, no susceptible de cirugía o radioterapia curativas.
    4. Tumor portador de una de las 2 mutaciones frecuentes del EGFR que se sabe que se asocian a sensibilidad a los ITC del EGFR (Ex19del, L858R)
    5. Es imprescindible la disponibilidad de una muestra de tumor de archivo, sin teñir, en cantidad suficiente para su análisis central del estado de mutación del EGFR.
    6.Paciente que no ha recibido tratamiento por un CPNM avanzado y elegible para recibir el tratamiento de primera línea con gefitinib o erlotinib elegido por el centro participante.
    E.4Principal exclusion criteria
    1. Treatment with any of the following:
    -Prior treatment with any systemic anti-cancer therapy for advanced NSCLC.
    - Prior treatment with an EGFR-TKI.
    -Major surgery within 4 weeks of the first dose of study drug.
    - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
    -Patients currently receiving medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4.
    - Treatment with an investigational drug within five half-lives of the compound or any of its related material.
    2. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug.
    3. Spinal cord compression, symptomatic and unstable brain metastases, requiring steroids over the last 4 weeks prior to randomisation in this study.
    4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
    5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
    6. Any of the following cardiac criteria:
    -Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
    -Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    -Any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
    7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
    1.Cualquiera de los siguientes tratamientos:
    -Tratamiento previo con cualquier terapia antineoplásica sistémica para CPNM avanzado
    -Tratamiento previo con un ITC del EGFR.
    -Cirugía mayor en el plazo de las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    -Radioterapia sobre más del 30% de la médula ósea o radioterapia de campo amplio en el plazo de las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    -Tratamiento actual con medicamentos o suplementos de herbolario que se sabe que son potentes inhibidores o inductores del citocromo P450 (CYP) 3A4.
    -Tratamiento con un fármaco en fase de investigación sin haber transcurrido cinco semividas de dicho producto o de cualquier material relacionado, si se conoce.
    2. Cualquier proceso maligno concomitante y/o activo de otro tipo que haya precisado tratamiento sistémico en el plazo de los 2 años anteriores a la primera dosis del fármaco del estudio.
    3. Compresión medular o metástasis cerebrales sintomáticas e inestables, que hayan requerido corticoides a lo largo de las 4 últimas semanas antes de la aleatorización en este estudio
    4. Toda evidencia de enfermedad sistémica severa o no controlada lo que incluye la hipertensión no controlada y las diátesis hemorrágicas activas; o infección activa, tal como hepatitis B, hepatitis C y el virus de la inmunodeficiencia humana (VIH).
    5. Náuseas y vómitos resistentes al tratamiento, enfermedades gastrointestinales crónicas, incapacidad de deglutir el producto formulado o resección intestinal importante previa que pueda impedir la absorción adecuada de AZD9291.
    6. Cualquiera de los siguientes criterios cardíacos:
    -Valor medio del intervalo QT corregido (QTc) en reposo >470 ms, obtenido a partir de 3 ECG, utilizando el valor del QTc calculado por el electrocardiógrafo del centro en la selección.
    -Cualquier anomalía clínicamente importante del ritmo, la conducción o la morfología del ECG.
    -Cualquier factor que aumente el riesgo de prolongación del QTc o de arritmias, o muerte súbita inexplicada en un familiar de primer grado menor de 40 años o cualquier medicamento concomitante que se sabe que prolonga el intervalo QT.
    7. Antecedentes médicos de neumopatía intersticial (NPI), NPI de origen farmacológico, neumonitis por radiación que precise tratamiento con corticoides, o cualquier evidencia de NPI clínicamente activa.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
    Supervivencia sin progresión (SSP) utilizando las evaluaciones del investigador según los Criterios de evaluación de la respuesta en los tumores sólidos (RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and every 6 weeks from randomization until progression
    En el momento basal y cada 6 semanas desde la aleatorización hasta la progresión
    E.5.2Secondary end point(s)
    1) Analysis of OS (Overall Survival) (key secondary endpoint)
    2) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13).
    EORTC QLQ-C30:
    Questionnaire consisting of 30 items measuring subjects general cancer symptoms and functioning.
    EORTC QLQ-LC13:
    A complementary questionnaire measuring lung cancer symptoms and side effects from conventional chemo- and radiotherapy.
    3) ORR (Objective Response Rate), Duration of Response (DoR), Disease Control Rate (DCR), Depth of response using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
    4) PK exposure parameters derived from plasma concentrations of AZD9291 and metabolites AZ5104 and AZ7550
    Pharmacokinetics data from this study will be analysed using a population PK approach and may also form part of a pooled analysis with other AZD9291 studies; results from these analyses will be reported separately from the CSR
    5) Assessing of patient satisfaction using Cancer Therapy Satisfaction Questionnaire 16 items (CTSQ-16)
    6) Safety and tolerability endpoints assessed by number and severity of adverse events, clinical chemistry, haematology, urinalysis, vital signs, physical examination, body weight, digital electrocardiogram (ECG), left Ventricular Ejection Fraction (LVEF), World Health Organization (WHO) Performance Status and Ophthalmologic assessment
    1)Análisis de la supervivencia global (criterio secundario de valoración clave)
    2)Cuestionario de calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer - Común de 30 elementos(EORTC QLQ-C30) y Cuestionario de calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer- Cáncer de pulmón de 13 elementos (EORTC QLQ-LC13).
    EORTC QLQ-C30:
    Cuestionario formado por 30 elementos que mide la actividad y los síntomas de los pacientes con cáncer de todos los tipos.
    EORTC QLQ-LC13:
    Cuestionario complementario que mide los síntomas del cáncer de pulmón y los efectos secundarios de la quimioterapia y la radioterapia convencionales.
    3)Tasas de respuesta objetiva (TRO), Duración de la respuesta,Tasa de control de la enfermedad,Profundidad de la respuesta utilizando la evaluaiones del investigador según los Criterios de evaluación de la respuesta en los tumores sólidos (RECIST 1.1).
    4)Parámetros de exposición farmacocinética derivados de concentraciones plasmáticas de AZD9291 y sus metabolitos AZ5104 y AZ7550.
    Los datos farmacocinéticos de este estudio se analizarán con un enfoque de FC poblacional, y también podrán formar parte de un análisis combinado con otros estudios de AZD9291; los resultados de estos análisis se presentarán por separado del informe del estudio clínico.
    5)Evaluar la satisfacción de los pacientes utilizando el Cancer Therapy Satisfaction Questionnaire de 16 elementos (CTSQ-16)
    6) Criterios de valoración de seguridad y tolerabilidad evaluados por número y severidad de acontecimentos adversos, Bioquímica sérica, hematología, análisis de orina, constantes vitales, exploración física, peso corporal, electrocardiograma (ECG) digital, fracción de eyección de ventrículo izquierdo (FEVI), Estado funcional de la Organización Mundial de la Salud (OMS) y evaluación oftalmológica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    A lo largo del ensayo
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    AZD9291 frente a un inhibidor establecido de la tirosina cinasa del receptor del factor de crecimien
    AZD9291 versus a standard of care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gefitinib o Erlotinib
    Gefitinib or Erlotinib
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Philippines
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Taiwan
    Thailand
    United Kingdom
    United States
    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 last visit of the last patient undergoing the study
    Última visita del último paciente en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 429
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 221
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 650
    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 will be treated in accordance with the regional 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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
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