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    Summary
    EudraCT Number:2016-001203-23
    Sponsor's Protocol Code Number:D419QC00001
    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:2017-02-07
    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 number2016-001203-23
    A.3Full title of the trial
    A Phase III, Randomized, Multicenter, Open-Label, Comparative Study to
    Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab
    in Combination With Platinum-Based Chemotherapy for the First-Line
    Treatment in Patients with Extensive Disease (Stage IV) Small-Cell Lung
    Cancer (SCLC)
    Ensayo en fase III, aleatorizado, multicéntrico, abierto y comparativo para determinar la eficacia de durvalumab o durvalumab y tremelimumab en combinación con quimioterapia basada en platino como tratamiento de primera línea en pacientes con cáncer de pulmón microcítico (CPM) en enfermedad avanzada (estadio IV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung Cancer
    Ensayo en fase III, abierto, con varios brazos para evaluar la eficacia de la inmunoterapia junto el tratamiendo de mantenimiento en pacientes diagnosticados con cáncer de pulmón microcítico en estadío avanzado
    A.3.2Name or abbreviated title of the trial where available
    A Phase III Randomised Study of Durva+/- Treme combined with SoC as 1st line treatment in ED-SCLC Pt
    Ensayo fase III, aleatorizado, de Durva+/-Treme en combinación con TM de 1ª línea en CPM-EP Pt
    A.4.1Sponsor's protocol code numberD419QC00001
    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 Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedurvalumab
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nametremelimumab
    D.3.2Product code MEDI1123
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    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: 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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    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 nameCarboplatin
    D.3.2Product code 61703-339-56
    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 INNcarboplatin
    D.3.9.1CAS number 41575-94-4
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastic agent
    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 Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    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 nameCisplatin
    D.3.2Product code 63323-103
    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 INNcisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 etoposide
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    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 nameEtoposide
    D.3.2Product code 63323-104
    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 INNetoposide
    D.3.9.1CAS number 33419-42-0
    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 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
    First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC)
    Tratamiento de primera línea en pacientes con cáncer de pulmón microcítico (CPM) en enfermedad avanzada (estadio IV)
    E.1.1.1Medical condition in easily understood language
    Treatment naïve patients with extensive-stage small-cell lung cancer
    Pacientes con cáncer de pulmón microcítico en estadío avanzado que no han recibido tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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 durvalumab + tremelimumab + EP treatment compared with EP in terms of overall survival (OS) and progression-free survival ( PFS).
    Evaluar la eficacia del tratamiento con durvalumab + tremelimumab +
    EP en comparación con EP en cuanto a la SG y la SLP.
    E.2.2Secondary objectives of the trial
    1.To further assess the efficacy of durvalumab + tremelimumab + EP treatment compared with EP in terms of ORR, APF6, APF12 and OS 18.
    2.To assess the efficacy of durvalumab + EP compared with EP in terms of ORR, PFS, OS, APF6, APF12, and OS18.
    3.To assess the efficacy of durvalumab + tremelimumab + EP treatment compared with durvalumab + EP in terms of PFS and OS.
    4.To assess the PK of both durvalumab and durvalumab + tremelimumab.
    5.To investigate the immunogenicity of durvalumab and durvalumab + tremelimumab.
    6.To assess the effect of the treatment on changes in symptoms and health-related QoL using EORTC QLQ-C30 v3 and QLQ-LC13.
    7.Safety objective: To assess the safety and tolerability profile of durvalumab and durvalumab + tremelimumab in combination with EP treatment compared with EP.
    1.Evaluar la eficacia del tratamiento con durvalumab + tremelimumab + EP en comparación con EP en cuanto a TRO, VSP6, VSP12 y SG18
    2.Evaluar la eficacia de durvalumab + EP en comparación con EP en
    cuanto a TRO, SLP, SG, VSP6, VSP12 y SG18
    3. Evaluar la eficacia del tratamiento con durvalumab + tremelimumab + EP en comparación con durvalumab + EP en cuanto a la SLP y la SG
    4. Evaluar la FC tanto de durvalumab como de tremelimumab
    5. Investigar la inmunogenia de durvalumab y de durvalumab + tremelimumab.
    6. Evaluar el efecto del tratamiento en los síntomas del CPM y la CdV
    relacionada con la salud utilizando los cuestionarios QLQ-C30 v3 y QLQLC13 de la EORTC.
    7. Objetivo de seguridad: Evaluar la seguridad y la tolerabilidad del
    tratamiento con durvalumab y durvalumab + tremelimumab combinado con EP en comparación con solo EP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage IV SCLC [T any, N any, M1 a/b]), including patients with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
    2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
    3. Life expectancy ≥12 weeks at Day 1.
    4. ECOG 0 or 1 at enrolment.
    5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
    6 .Body weight >30 kg.
    7. Adequate organ and marrow function.
    1. Pacientes con enfermedad extendida documentada histológica o citológicamente (CPM en estadio IV según el American Joint Committee on Cancer [T cualquiera, N cualquiera, M1 a/b]), incluyendo pacientes con T3-4 debido a múltiples nódulos pulmonares que son demasiado extensos o que tienen el volumen del tumor/nódulo demasiado grande para ser abarcado en una radiación tolerable. Metástasis cerebrales; deben ser asintomáticas o tratadas y estables sin esteroides ni anticonvulsivos durante al menos 1 mes antes de tratamiento del estudio.
    2. Pacientes idoneos para recibir el régimen de quimioterapia basada en platino como primera línea de tratamiento.
    3. Esperanza de vida >o= a 12 meses en el Día 1
    4. ECOG 0 o 1 en el momento de inclusión.
    5. No exposición anterior a tratamiento inmune excluyendo tratamiento de vacunas anticancerígenas.
    6. Peso >30 kg
    7. Función de los órganos y de la medula adecuada.
    E.4Principal exclusion criteria
    1. Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
    2. Any other concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
    3. History of allogenic organ transplantation.
    4. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
    5. Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
    6. History of another primary malignancy
    7. Active infection including tuberculosis, HIV, hepatitis B anc C
    8. Current or prior use of immunosuppressive medication within 14 days before the first IP dose
    9. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control..
    10. Past medical history of interstitial lung disease, drug-induced pneumonitis, or any evidence of clinically active interstitial lung disease.
    1. Antecedentes de radioterapia en el tórax antes del tratamiento sistémico o terapia de radiación en el tórax planeada y consolidada (exceptuando cuidado paliativos fuera del tórax)
    2. Cualquier otro tratamiento concurrente como quimioterapia, IP, biológica u hormonal para el tratamiento del cáncer.
    3. Antecedentes de trasplantes de órganos halogenados.
    4. Síndrome paraneoplásico de naturaleza autoinmune, que requiere tratamiento sistémico o sintomatológico clínico que sugiere un empeoramiento del SNP
    5. Enfermedad intercurrente incontrolada o enfermedad psiquiatra/situaciones sociales que podrían limitar la conformidad de los requerimientos del estudio, aumento relevante del riesgo de incidencias de AAs o del compromiso de la habilidad del paciente de dar el consentimiento informado firmado
    6. Antecedentes de otro tumor maligno primario
    7. Infección activa incluyendo tuberculosis, HIV, hepatitis B y C
    8. Uso previo o actual de medicación inmunosupresora dentro de los 14 días antes de la primera dosis del medicamento en investigación
    9. Pacientes femeninas que están embarazadas o en lactancia o pacientes masculinos o femeninos con capacidad de reproducirse que no desean utilizar anticonceptivos efectivos.
    10. Antecedentes personales de enfermedad pulmonar intersticial, neumonitis inducida por fármacos, o cualquier evidencia de enfermedad pulmonar intersticial clínicamente activa.
    E.5 End points
    E.5.1Primary end point(s)
    1.Overall survival (OS)- the time from the date of randomization until death due to any cause.
    2.Progression free survival (PFS)- the time from the date of randomization until the date of objective disease progression or death.
    1.La supervivencia global (SG)-tiempo desde el día de la aleatorización hasta el fallecimiento debido a cualquier causa.
    2.La supervivencia libre de progresión (SLP)-tiempo desde el día de la
    aleatorización hasta el día fijado de la progresión de la enfermedad o
    muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 34 months after the first patient has been randomized
    2. 23 months after the first patient has been randomized
    1. 34 meses meses después de la aleatorización del primer paciente.
    2. 23 meses meses después de la aleatorización del primer paciente.
    E.5.2Secondary end point(s)
    1.Objective Response Rate (ORR) -the number (%) of patients with at least 1 visit response of CR or PR.
    2.Proportion of patients alive and progression free at 6 (APF6) and 12 months (APF12).
    3. Proportion of patients alive at 18 months (OS18).
    1.Tasa de respuesta objetiva (TRO)-el número de pacientes (%) con al
    menos 1 visita de respuesta de RC y RP
    2.La proporción de pacientes vivos y sin progresión a los 6 (VSP6) y 12
    meses (VSP12)
    3.Proporción de pacientes vivos a los 18 meses (SG18)
    E.5.2.1Timepoint(s) of evaluation of this end point
    23 months after the first patient has been randomized
    23 meses meses después de la aleatorización del primer paciente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA104
    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
    Austria
    Brazil
    Bulgaria
    China
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Turkey
    Ukraine
    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 the study is defined as the “last visit of the last patient undergoing the study.”
    El final del estudio se define como "la última visita del último sujeto que participe en el estudio"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days21
    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: 477
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 318
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 477
    F.4.2.2In the whole clinical trial 795
    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 the final analysis, AstraZeneca will continue to supply open-label drug to patients
    receiving durvalumab (MEDI4736) monotherapy up to confirmed progression
    Despues del análisis final, AstraZeneca continuará suministrando medicación abierta a los pacientes que estén recibiendo durvalumab (MEDI4736) en monoterapia hasta que confirmen su progresión
    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 Decision2017-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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