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    Summary
    EudraCT Number:2014-003083-21
    Sponsor's Protocol Code Number:GO29431
    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:2015-06-01
    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 number2014-003083-21
    A.3Full title of the trial
    A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (Anti?PDL1 ANTIBODY) COMPARED WITH CISPLATIN OR CARBOPLATIN+PEMETREXED FOR PD-L1?SELECTED CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV NON-SQUAMOUS NON?SMALL CELL LUNG CANCER
    ESTUDIO DE FASE III, ABIERTO Y ALEATORIZADO PARA COMPARAR MPDL3280A (ANTICUERPO ANTI-PD-L1) CON CISPLATINO O CARBOPLATINO + PEMETREXED EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO Y NO EPIDERMOIDE EN ESTADIO IV SELECCIONADOS POR PD-L1 QUE NO HAN RECIBIDO QUIMIOTERAPIA PREVIA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and efficacy of MPDL3280A (anti-PDL1 antibody) compared to platinum-based chemotherapy in patients with metastatic, non-squamous, PD-L1-selected, non-small cell lung cancer that has not been treated with chemotherapy.
    Estudio para evaluar la seguridad y la eficacia de MPDL3280A (anticuerpo Anti-DP-L1) comparado con quimioterapia basada en platino en pacientes con cáncer de pulmón no microcítico y no epidermoide metastásico seleccionados por PD-L1 que no han recibido quimioterapia previa.
    A.4.1Sponsor's protocol code numberGO29431
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMPDL3280A-RO5541267
    D.3.4Pharmaceutical form 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 INNNot Yet defined
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.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
    Stage IV, Non-Squamous, Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico y no epidermoide en estadio IV.
    E.1.1.1Medical condition in easily understood language
    Lung cancer that has spread to areas near the lungs or other organs and has not yet been treated by chemotherapy
    Cáncer de pulmón que se ha expandido a áreas cercanas al pulmón u otros órganos y que no ha sido tratado todavia con quimioterapia.
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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
    The primary objective for this study is to evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin + pemetrexed in chemotherapy-naive patients with Stage IV non squamous NSCLC, as measured by investigator-assessed PFS according to RECIST v1.1
    El objetivo principal en este estudio es evaluar la eficacia de MPDL3280A en comparación con carboplatino o cisplatino + pemetrexed en pacientes con cáncer de pulmón no microcítico (CPNM) y no escamoso estadio IV que no han recibido quimioterapia previa, determinada mediante la supervivencia libre de progresión (SLP) evaluada por el investigador conforme a los criterios RECIST v1.1.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin + pemetrexed as measured by ORR according to RECIST v1.1 assessed by investigator
    To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin + pemetrexed as measured by OS
    To determine the impact of MPDL3280A compared with carboplatin or cisplatin +pemetrexed as measured by time to deterioration (TTD) in patient reported lung cancer symptom (cough, dyspnea, chest pain) score
    To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin + pemetrexed as measured by Independent Review Facility (IRF)-assessed PFS according to RECIST v1.1
    To evaluate the efficacy of MPDL3280A as measured by investigator-assessed DOR according to RECIST v1.1
    To evaluate the efficacy of MPDL3280A as measured by investigator-assessed time in response (TIR) according to RECIST v1.1
    To evaluate the OS rate at 1 and 2 years in each treatment arm
    -Evaluar la eficacia de MPDL3280A en comparación con carboplatino o cisplatino+pemetrexed, determinada mediante la TRO evaluada por el investigador conforme a RECIST v1.1.-Evaluar la eficacia de MPDL3280A en comparación con carboplatino o cisplatino+pemetrexed, determinada mediante la SG.-Determinar el efecto de MPDL3280A en comparación con carboplatino o cisplatino+pemetrexed, medido mediante el THD en la puntuación de los síntomas de cáncer de pulmón comunicados por el paciente (tos, disnea, dolor torácico).-Evaluar la eficacia de MPDL3280A en comparación con carboplatino o cisplatino+pemetrexed determinada mediante la SLP evaluada por un centro de revisión independiente (CRI) conforme a RECIST v1.1.-Evaluar la eficacia de MPDL3280A determinada mediante la DR evaluada por el investigador conforme a RECIST v1.1.-Evaluar la eficacia de MPDL3280A determinada mediante el tiempo en respuesta (TER) conforme a RECIST v1.1. -Evaluar la SG al cabo de 1 y 2 años en cada grupo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?ECOG performance status of 0 or 1
    ?Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
    ?No prior treatment for Stage IV non-squamous NSCLC, unless patient had a previously detected sensitizing EGFR mutation or ALK fusion oncogene
    oPatients with a known sensitizing mutation in the EGFR gene or ALK fusion oncogene must have experienced disease progression or intolerance to treatment any EGFR TKI approved for the treatment of EGFR-mutant NSCLC or any ALK inhibitor approved for the treatment of NSCLC in patients having an ALK fusion oncogene, respectively.
    ?Patient with a history of treated asymptomatic CNS metastases
    ?Tumor PD-L1 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
    ?Measurable disease, as defined by RECIST v1.1
    ?Adequate hematologic and end-organ function
    ?For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception and to continue its use for 90 days after the last dose of MPDL3280A
    ?Women who are not postmenopausal (? 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
    - Estado funcional ECOG de 0 o 1.
    - CPNM no escamoso, confirmado mediante histología o citología, estadio IV.
    - Ausencia de tratamiento previo para el CPNM no escamoso estadio IV, salvo que se haya detectado previamente en el paciente una mutación de EGFR
    sensibilizadora o un oncogén de fusión ALK. Los pacientes con una mutación sensibilizadora conocida en el gen EGFR o con un oncogén de fusión ALK tendrán que haber presentado progresión de la enfermedad o intolerancia al tratamiento con cualquier TKI de EGFR aprobado para tratar el CPNM con mutación de EGFR o con cualquier inhibidor de ALK aprobado para el tratamiento del CPNM en pacientes con un oncogén de fusión ALK, respectivamente.
    - Pacientes con antecedentes de metástasis asintomáticas tratadas del SNC.
    - Expresión de PD-L1 en el tumor, determinada mediante un análisis de IHQ realizado en un laboratorio central con tejido tumoral de archivo obtenido anteriormente o tejido obtenido a partir de una biopsia practicada en la selección.
    - Enfermedad mensurable, definida conforme a los criterios RECIST v1.1.
    - Función hematológica y de órganos efectores adecuada.
    - En las pacientes en edad fértil y los pacientes con parejas en edad fértil, compromiso (por parte del paciente o la pareja) de utilizar un método anticonceptivo muy eficaz y de seguir utilizándolo durante 90 días después de la última dosis de MPDL3280A.
    - Las mujeres que no sean posmenopáusicas (? 12 meses de amenorrea no inducida por el tratamiento) o no estén esterilizadas quirúrgicamente deberán tener una prueba de embarazo en suero negativa en los 14 días previos al inicio del tratamiento con el fármaco del estudio.
    E.4Principal exclusion criteria
    ?Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
    ?Leptomeningeal disease
    ?Uncontrolled tumor-related pain
    ?Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    ?Uncontrolled or symptomatic hypercalcemia
    ?Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death
    ?History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener?s granulomatosis, Sjögren?s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
    ?History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
    ?Positive test for HIV
    ?Patients with active hepatitis B or hepatitis C
    ?Active tuberculosis
    ?Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    ?Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
    ?Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
    ?Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization
    ?Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
    ?Treatment with systemic immunostimulatory agents (including but not limited to interferons, IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
    ?Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to randomization
    - Metástasis en el SNC activas o no tratadas, determinadas mediante TC o resonancia magnética (RM) durante las evaluaciones radiológicas de selección y precedentes.
    - Afectación leptomeníngea.
    - Dolor no controlado relacionado con el tumor.
    - Derrame pleural, derrame pericárdico o ascitis no controlados con necesidad de procedimientos de drenaje recurrentes (una vez al mes o con más frecuencia).
    - Hipercalcemia sintomática o no controlada.
    - Tumores malignos distintos del CPNM en los 5 años previos a la aleatorización, salvo aquellos con un riesgo insignificante de metástasis o muerte.
    - Antecedentes de enfermedad autoinmunitaria, como por ejemplo, miastenia grave, miositis, hepatitis autoinmunitaria, lupus eritematoso sistémico, artritis reumatoide, enfermedad inflamatoria intestinal, trombosis vascular asociada a síndrome antifosfolipídico, granulomatosis de Wegener, síndrome de Sjögren, síndrome de Guillain-Barré, esclerosis múltiple, vasculitis o glomerulonefritis.
    - Antecedentes de fibrosis pulmonar idiopática, neumonía organizada (por ejemplo, bronquiolitis obliterante), neumonitis medicamentosa, neumonitis idiopática o signos de neumonitis activa en la TC de tórax de selección.
    - Resultado positivo en una prueba del VIH.
    - Pacientes con hepatitis B activa o hepatitis C.
    - Tuberculosis active.
    - Infecciones graves en las 4 semanas previas a la aleatorización, tales como hospitalización por complicaciones de una infección, bacteriemia o neumonía grave.
    - Enfermedad cardiovascular importante, como cardiopatía clase II o superior según la New York Heart Association, infarto de miocardio en los 3 meses previos a la aleatorización, arritmias inestables o angina de pecho inestable.
    - Cualquier tratamiento antineoplásico aprobado, incluida quimioterapia, o tratamiento hormonal en las 3 semanas previas al comienzo del tratamiento del estudio.
    - Cualquier tratamiento antineoplásico aprobado, incluida quimioterapia, o tratamiento hormonal en las 3 semanas previas al comienzo del tratamiento del estudio.
    - Tratamiento con otros fármacos en investigación o participación en otro ensayo clínico con intención terapéutica en los 28 días previos a la aleatorización.
    - Tratamiento previo con agonistas de CD137, terapia inmunológica de bloqueo de puntos de control y anticuerpos terapéuticos anti-PD-1 y anti-PD-L1.
    - Tratamiento con inmunoestimuladores sistémicos (por ejemplo, interferones o IL-2) en las 4 semanas previas a la aleatorización o el equivalente a cinco semividas del fármaco, lo que sea más breve.
    - Tratamiento con inmunosupresores sistémicos (por ejemplo, prednisona, ciclofosfamida, azatioprina, metotrexato, talidomida y antagonistas del factor de necrosis tumoral [anti-TNF]) en las 2 semanas previas a la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    ?PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first
    SLP, definida como el tiempo transcurrido entre la aleatorización y el primer episodio de progresión de la enfermedad según lo determinado por el investigador conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.1
    Por favor, consultar E.5.1.
    E.5.2Secondary end point(s)
    ?Objective response, defined as PR plus CR as determined by the investigator according to RECIST v1.1
    ?OS, defined as the time from randomization to death from any cause
    ?TTD in patient reported lung cancer symptoms (cough, dyspnea, or chest pain, whichever occurs first) with use of the SILC scale symptom score, defined as time from randomization to the first deterioration maintained for two assessments or one assessment followed by death from any cause within 1 week
    ?PFS, defined as the time from randomization to the first occurrence of disease progression as determined by IRF using RECIST v1.1 or death from any cause, whichever occurs first
    ?DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first
    ?TIR, defined as the same as DOR for responders. For non-responders, TIR is defined as date of randomization plus 1 day.
    ?1-year OS and 2-year OS
    ?TTD in patient reported lung cancer symptoms, defined as time from randomization to deterioration (10 point change) on each of the EORTC QLQ-C30 and EORTC QLQ-LC13 symptom subscales (cough, dyspnea [single item and multi item subscales], chest pain, arm/shoulder pain, or fatigue) maintained for two assessments or one assessment followed by death from any cause within 3 weeks
    ?Change from baseline in patient-reported lung cancer symptoms (chest pain, dyspnea, and cough) on the symptom severity score of the SILC scale
    - Respuesta objetiva, definida como RP más RC, según lo determinado por el investigador con arreglo a los criterios RECIST v1.1.
    - SG, definida como el tiempo transcurrido entre la aleatorización y la muerte por cualquier causa.
    - THD de los síntomas de cáncer de pulmón comunicados por el paciente (tos, disnea o dolor torácico, lo que ocurra antes) con una puntuación de la intensidad de los síntomas basada en la escala SILC, definido como el tiempo transcurrido desde la aleatorización hasta el primer deterioro mantenido durante dos evaluaciones o una evaluación seguida de muerte por cualquier causa en el plazo de 1 semana.
    - SLP, definida como el tiempo transcurrido entre la aleatorización y el primer episodio de progresión de la enfermedad según lo determinado por el CRI conforme a los criterios RECIST v1.1, o muerte por cualquier causa, lo que ocurra antes.
    - DR, definida como el tiempo transcurrido entre el primer episodio de respuesta objetiva documentada y la fecha de progresión de la enfermedad según lo determinado por el investigador conforme a los criterios RECIST v1.1, o muerte por cualquier causa, lo que ocurra antes.
    - En los pacientes con respuesta, el TER se define igual que la DR. En los pacientes sin respuesta, el TER se define como la fecha de la aleatorización más 1 día.
    - SG al cabo de 1 año y SG al cabo de 2 años.
    - THD de los síntomas de cáncer de pulmón comunicados por el paciente, definido como el tiempo transcurrido entre la aleatorización y el deterioro (variación de 10 puntos) en cada una de las subescalas de síntomas de los cuestionarios QLQ-C30 y QLQ-LC13 de la EORTC (tos, disnea [subescala con un solo apartado y subescala con varios apartados], dolor torácico, dolor de brazos/hombros o cansancio) mantenido durante dos evaluaciones o una evaluación seguida de muerte por cualquier causa en el plazo de 3 semanas.
    - Variación con respecto al momento basal de los síntomas del cáncer de pulmón comunicados por el paciente (dolor torácico, disnea y tos) según la puntuación de intensidad de los síntomas de la escala SILC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    Por favor, consultar E.5.2.
    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 No
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Italy
    Japan
    Korea, Republic of
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    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
    The end of study is when 291 deaths in the ITT population have been observed. In addition, the Sponsor may decide to terminate the study at any time.
    El estudio finalizará cuando se hayan observado 291 muertes en la población IT. Además, el promotor podrá decidir que pone fin al estudio en cualquier momento.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 400
    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)
    The Sponsor will evaluate the appropriateness of continuing to provide MPDL3280A to patients assigned to this treatment after evaluating the primary and secondary efficacy outcome measures and safety data gathered in the study.
    El promotor valorará la conveniencia de seguir proporcionando MPDL3280A a los pacientes asignados a recibir dicho tratamiento tras evaluar los criterios principales y secundarios de valoración de la eficacia y los datos de seguridad recogidos en el estudio.
    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 Decision2015-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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