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    Summary
    EudraCT Number:2014-005060-15
    Sponsor's Protocol Code Number:EMR100070-004
    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:2015-06-15
    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 number2014-005060-15
    A.3Full title of the trial
    A Phase III open-label, multicenter trial of avelumab (MSB0010718C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum-containing doublet
    Ensayo de fase III, abierto y multicéntrico de avelumab (MSB0010718C) frente a docetaxel en sujetos con carcinoma pulmonar no microcítico que ha progresado tras un doblete con platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab in Non-Small Cell Lung Cancer
    Avelumab en carcinoma pulmonar no microcítico
    A.4.1Sponsor's protocol code numberEMR100070-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02395172
    A.5.4Other Identifiers
    Name:IND Number: pIND 122898Number:IND Number: pIND 122898
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles S.L.
    B.5.2Functional name of contact pointRegulatory & Start Up Department
    B.5.3 Address:
    B.5.3.1Street AddressVia de los Poblados,3,Edificio 7-8,5ª Planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900808668
    B.5.5Fax number+34918066456
    B.5.6E-mailensayosclinicos@quintiles.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 nameAvelumab
    D.3.2Product code MSB0010718C
    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 INNAvelumab
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameAnti PD-L1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 Docetaxel Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderRoyal Leamington Spa.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDocetaxel
    D.3.2Product code docetaxel
    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 INNdocetaxel
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codedocetaxel hospira
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    carcinoma pulmonar no microcítico
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer
    carcinoma pulmonar no microcítico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term 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 demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet
    Demostrar superioridad en la supervivencia general (SG) de avelumab frente a docetaxel en sujetos con carcinoma pulmonar no microcítico (CPNM) positivo para el ligando 1 de muerte programada (PD-L1) (+; determinado mediante una prueba diagnóstica acompañante en desarrollo) tras fracaso del doblete basado en platino
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:

    ? To demonstrate superiority with regard to OS of avelumab versus docetaxel in the intention-to-treat (ITT) population
    ? To demonstrate superiority with regard to the objective response rate (ORR) of avelumab versus docetaxel in PD-L1+ subjects
    ? To demonstrate superiority with regard to progression free survival (PFS) of avelumab versus docetaxel in PD-L1+ subjects
    ? To demonstrate superiority with regard to the ORR of avelumab versus docetaxel in the ITT population
    ? To demonstrate superiority with regard to PFS of avelumab versus docetaxel in the ITT population
    ? To compare the subject-reported outcomes / quality of life when treated with avelumab versus docetaxel using the EuroQOL 5-dimensions questionnaire (EQ 5D) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 and module QLQ-LC13 in the ITT population
    ? To determine the safety and tolerability of avelumab
    Objetivos secundarios
    Los objetivos secundarios son los siguientes:
    ? Demostrar superioridad en SG de avelumab frente a docetaxel en la población de intención de tratar (ITT)
    ? Demostrar superioridad en la tasa de respuesta objetiva (TRO) de avelumab frente a docetaxel en sujetos PD-L1+
    ? Demostrar superioridad en la supervivencia sin progresión (SSP) de avelumab frente a docetaxel en sujetos PD-L1+
    ? Demostrar superioridad en la TRO de avelumab frente a docetaxel en la población ITT
    ? Demostrar superioridad en la SSP de avelumab frente a docetaxel en la población ITT
    ? Comparar los resultados comunicados por el sujeto y la calidad de vida cuando se ha tratado con avelumab frente a docetaxel, mediante el cuestionario de 5 dimensiones EuroQoL (EQ-5D), el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) y el módulo QLQ-LC13 en la población ITT
    ? Determinar la seguridad y la tolerabilidad de avelumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    - Signed written informed consent before any trial related procedure
    - Male or female subjects aged ? 18 years
    - Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
    - Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
    - Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression
    - Subjects must have progressed after an acceptable therapy defined as follows:
    a. Subjects must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination
    OR
    b. Subjects must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
    - Subjects with non-squamous cell NSCLC of unknown EGFR mutation status will require testing (local laboratory, or central laboratory if local testing is not available). For subjects with a tumor that harbors an activating EGFR mutation, acceptable prior therapy is also defined as a treatment with an EGFR-targeting tyrosine kinase inhibitor (TKI) given before or after treatment with a platinum-based combination chemotherapy as defined above. Subjects with a tumor that harbors an activating EGFR mutation must have failed both the platinum-based doublet and the EGFR-targeting TKI. Treatment with more than 1 EGFR targeting TKI is acceptable
    - ECOG PS of 0 to 1 at trial entry
    - Estimated life expectancy of more than 12 weeks
    - Adequate hematological function defined by WBC count ? 2.5 × 109/L with absolute neutrophil count (ANC) ? 1.5 × 109/L, lymphocyte count ? 0.5 × 109/L, platelet count ? 100 × 109/L, and hemoglobin ? 9 g/dL (may have been transfused)
    - Adequate hepatic function defined by a total bilirubin level ? 1.0 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ? 2.5 × ULN for all subjects
    - Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)

    Other protocol defined criteria could apply
    Criterios de inclusión
    1. Consentimiento informado escrito y firmado antes de que se lleve a cabo cualquier procedimiento relacionado con el ensayo que no forme parte del tratamiento estándar del paciente.
    2. Sujetos ?18 años de edad, de uno u otro sexo.
    3. Disponibilidad de un bloque incluido en parafina y fijado en formol con el tejido tumoral o de 7 portaobjetos sin tinción del tumor aptos para la evaluación de la expresión de PD-L1.
    4. Tumor diagnosticado como evaluable para la expresión de PD-L1+ de acuerdo con la evaluación del laboratorio central.
    5. Sujetos con un CPNM en estadio IIIb-IV o recurrente y confirmado histológicamente que han experimentado una progresión de la enfermedad.
    6. Los sujetos deben haber sufrido progresión después de un tratamiento aceptable en los siguientes términos:
    a. Los sujetos deben haber sufrido progresión durante o tras un mínimo de 2 ciclos de 1 tanda de tratamiento de combinación de platino administrado para el tratamiento de una enfermedad metastásica. Se permiten antecedentes de tratamiento de mantenimiento de continuación (empleo de un fármaco sin platino desde la combinación inicial) o de cambio (empleo de un agente diferente), siempre que no haya habido progresión después de la combinación inicial. También se permite un cambio de fármacos durante el tratamiento para el control de toxicidades, siempre que no haya habido progresión tras la combinación inicial.
    O
    b. Los sujetos deben haber sufrido progresión en un plazo de 6 meses tras la finalización de una quimioterapia adyuvante, neoadyuvante o definitiva basada en platino o durante una pauta de quimiorradiación concomitante para enfermedades localmente avanzadas.
    7. En los sujetos con un CPNM de células no epidermoides y situación de mutación EGFR desconocida será necesario realizar pruebas (en un laboratorio local o en un laboratorio central si no existe un laboratorio local). En los sujetos diagnosticados con un tumor que contenga una mutación activadora del EGFR, el tratamiento previo aceptable se define también como un tratamiento con inhibidor de la tirosina cinasa (TKI) dirigido a EGFR, administrado con anterioridad o posterioridad a un tratamiento de quimioterapia con una combinación basada en platino definido anteriormente. Los sujetos con un tumor que contenga una mutación activadora del EGFR deben no haber respondido ni al doblete basado en platino ni al TKI dirigido al EGFR. Se acepta el tratamiento con más de un TKI dirigido al EGFR..
    8. EG ECOG de 0 a 1 en el momento de incorporación al ensayo.
    9. Esperanza de vida estimada superior a 12 semanas.
    10. Función hematológica adecuada, definida por un recuento de LEU ?2,5 × 109/l, con un recuento absoluto de neutrófilos (RAN) ?1,5 x 109/l, recuento de linfocitos ?0,5 × 109/l, recuento de plaquetas ?100 × 109/l y hemoglobina ?9 g/dl (puede haberse hecho transfusión).
    11. Función hepática adecuada definida por una concentración de bilirrubina total ?1,0 veces el rango del límite superior de la normalidad (LSN), concentraciones de aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ?2,5 veces el LSN para todos los sujetos.
    12. Función renal adecuada definida mediante un aclaramiento calculado de la creatinina >30 ml/min de acuerdo con la fórmula de Cockcroft-Gault (o el método estándar institucional local).
    Podrían aplicarse otros criterios definidos el el protocolo.
    E.4Principal exclusion criteria
    Exclusion criteria
    - In the United States only, subjects with a squamous cell histology will be excluded
    - Systemic anticancer therapy administered after disease progression during or following a platinum based combination, with the following exception: Subjects whose disease harbors an activating EGFR mutation who received an EGFR inhibitor AFTER a minimum of 2 cycles of first-line platinum-based therapy. Subjects who tested undetermined or wild-type for EGFR but were previously treated with a TKI are not eligible unless retested and confirmed to be activating EGFR mutation positive
    - Subjects with non-squamous cell NSCLC whose disease harbors an anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown ALK status will require testing for ALK rearrangement (local laboratory, or central laboratory if local testing is not available) and must be determined to be ALK wild-type to be eligible for this trial
    - Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4). Prior therapy with a cancer vaccine is acceptable
    - Concurrent anticancer treatment
    - Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the subject has not fully recovered from the surgery within 4 weeks of randomization
    - Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
    - All subjects with brain metastases, except those meeting the following criteria:
    a. Brain metastases have been treated locally, and
    b. No ongoing neurological symptoms that are related to the brain localization of the disease
    - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
    a. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
    b. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ? 10 mg or 10 mg equivalent prednisone per day
    c. Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
    - Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ? 10 mg per day of equivalent prednisone

    Other protocol defined criteria could apply
    Criterios de exclusión
    1. Solo en los Estados Unidos, se excluirán a los sujetos con histología de células epidermoides
    2. Tratamiento antineoplásico sistémico administrado tras la observación de progresión de la enfermedad durante o a continuación de una combinación basada en platino, con la siguiente excepción:
    Sujetos cuya enfermedad contenga una mutación activadora de EGFR y que recibieron un inhibidor de EGFR TRAS un mínimo de 2 ciclos de tratamiento basado en platino de primera línea. No son aptos los sujetos tratados previamente con TKI y que dieron en la prueba EGFR indeterminado o de tipo salvaje, a menos que se repita la prueba y se confirme que presentan una mutación activadora de EGFR positiva.
    3. No serán aptos para este estudio los sujetos con un CPNM de células no epidermoides cuya enfermedad contiene un reajuste de la cinasa del linfoma anaplásico (ALK). Los sujetos con un estado desconocido de ALK deberán ser evaluados de un reajuste de ALK (en un laboratorio local o en un laboratorio central cuando no se disponga de pruebas locales), y para poder ser aptos para este ensayo deberá determinarse que son ALK de tipo salvaje
    4. Tratamiento anterior con anticuerpos/fármacos dirigidos a las proteínas correguladoras de los linfocitos T (puntos de control inmunitario), tales como PD-1, PD-L1 o el antígeno-4 asociado al linfocito T citotóxico (CTLA-4). Se acepta el tratamiento anterior con una vacuna contra el cáncer.
    5. Tratamiento concomitante contra el cáncer (por ejemplo, tratamiento citorreductor, radioterapia [a excepción de la radioterapia ósea paliativa], tratamiento inmunitario o tratamiento con citocinas, a excepción de la eritropoyetina).
    6. Intervención quirúrgica mayor por cualquier razón, excepto la biopsia diagnóstica, en las 4 semanas anteriores a la aleatorización o si el sujeto no se ha recuperado por completo de la cirugía en las 4 semanas anteriores a la aleatorización.
    7. Los sujetos que reciben inmunosupresores (como esteroides) por cualquier motivo deberán reducir progresivamente esos fármacos antes de iniciar el tratamiento del estudio (con la excepción de los pacientes con insuficiencia adrenal, que pueden seguir recibiendo corticoesteroides a una dosis de sustitución fisiológica, equivalente a <10 mg de prednisona al día). Nota: los sujetos que reciban bisfosfonato o denosumab son aptos siempre que el tratamiento se hubiera iniciado al menos 14 días antes de la primera dosis del tratamiento del ensayo.
    8. Todos los sujetos con metástasis cerebral, salvo quienes cumplan los siguientes criterios:
    a. Metástasis cerebral tratada localmente y
    b. No hay síntomas neurológicos en curso relacionados con la localización cerebral de la enfermedad (se aceptan secuelas que sean consecuencia del tratamiento de la metástasis cerebral).
    9. Neoplasia maligna previa (distinta de CPNM) en los 5 años anteriores, a excepción del carcinoma basocelular o epidermoide, o del carcinoma localizado (vesical, cervical, colorrectal, mamario).
    10. Trasplante anterior de órganos, incluido el alotrasplante de células madre.
    11. Infecciones agudas o crónicas significativas (entre otras:
    Antecedentes conocidos de un resultado positivo en la prueba de detección del virus de la inmunodeficiencia humana (VIH) o síndrome de inmunodeficiencia adquirida conocido.
    Cualquier prueba positiva de VHB o VHC que indique una infección aguda o crónica (prueba a realizar en la selección).
    12. Enfermedad autoinmunitaria activa que pueda empeorar al recibir un inmunoestimulante:
    a. Son aptos los sujetos que padecen diabetes de tipo I, vitiligo, psoriasis, hipotiroidismo o hipertiroidismo que no requieran tratamiento inmunosupresor.
    b. Son aptos los sujetos que requieran restitución hormonal con corticoesteroides si estos se administran únicamente con el objetivo de la restitución hormonal y en dosis diarias de ?10 mg o 10 mg de prednisona equivalente.
    c. Administración de esteroides a través de una vía que se considere que provoca una exposición sistémica mínima (se aceptan las vías tópica, intranasal, intraocular o inhalatoria).
    13. Se acepta la administración previa o en curso de esteroides sistémicos para el tratamiento de una reacción alérgica aguda, siempre que se prevea que la administración de esteroides finalizará en 14 días o que la dosis diaria tras 14 días será ?10 mg de prednisona equivalente.

    Podrían aplicarse otros criterios definidos el el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival time
    Tiempo de supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from 1st randomization up to 21 months
    El tiempo desde la 1ª randomizacion hasta el mes 21
    E.5.2Secondary end point(s)
    Secondary endpoints:
    ?Progression-Free Survival (PFS) Time
    ?Best Overall Response (BOR)
    ?Quality of Life EuroQuol-5D Health Outcome Questionnaire
    ?Quality of Life Assessment European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
    ?Quality Of Life Assessment EORTC Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13)
    ? Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
    Objetivos Secundarios:

    - El tiempo de supervivencia sin progresión (SSP)
    - la mejor respuesta general (MRG)
    - Comparar los resultados comunicados por el sujeto y la calidad de vida cuando se ha tratado con avelumab frente a docetaxel, mediante el cuestionario de 5 dimensiones EuroQoL (EQ-5D), el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) y el módulo QLQ-LC13 en la población ITT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from 1st randomization up to 21 months
    El tiempo desde la 1ª randomizacion hasta el mes 21
    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 No
    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 No
    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 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) 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA141
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Turkey
    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
    last patient last follow-up (5 years after last subject receives last dose of avelumab)
    la ultima visita de seguimento del ultimo paciente (5 años después de que el último sujeto reciba la última dosis de avelumab)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 455
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 195
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 261
    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)
    After a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site?s standard of care and generally accepted medical practice and depending on the subject?s individual medical needs.
    Upon withdrawal from the trial, subjects may receive whatever care they and their physicians agree upon.
    Después de que un sujeto haya completado el tratamiento o se ha retirado del ensayo, deberá recibir el tratamiento habitual, si es necesario, de conformidad con el tratamiento estándar del centro del ensayo y con la práctica médica generalmente aceptada, dependiendo de las necesidades médicas particulares de ese sujeto.
    Cuando se produzca la retirada del tratamiento del ensayo, los sujetos podrán recibir cualquier tipo de atención que se acuerde entre ellos y sus médicos.
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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