Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-000867-10
    Sponsor's Protocol Code Number:D933QC00001
    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:2018-11-16
    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 number2018-000867-10
    A.3Full title of the trial
    A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III Limited Disease Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
    Ensayo en fase III, internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de durvalumab o durvalumab y tremelimumab como tratamiento de consolidación en pacientes con cáncer de pulmón microcítico con enfermedad limitada en estadio I-III que no han progresado después de un tratamiento concomitante de quimiorradioterapia (ADRIATIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Stage I-III Limited Disease Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
    Ensayo de Durvalumab + Tremelimumab, Durvalumab y Placebo en el cáncer de pulmón de células pequeñas de enfermedad limitada en estadio I-III en pacientes que no han progresado después de tratamiento concomitante de quimiorradioterapia
    A.3.2Name or abbreviated title of the trial where available
    ADRIATIC
    ADRIATIC
    A.4.1Sponsor's protocol code numberD933QC00001
    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 AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformationcenter@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 and solvent 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.3.9.3Other descriptive nameMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTREMELIMUMAB
    D.3.9.1CAS number 745013-59-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.9.3Other descriptive nameMEDI1123
    D.3.9.4EV Substance CodeSUB37101
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Stage I-III Limited Disease Small-Cell Lung Cancer (LD-SCLC)
    Pacientes con cáncer de pulmón microcítico con enfermedad limitada en estadio I-III(LD-SCLC)
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "Small Cell Lung Cancer" (SCLC)
    Tipo específico de cáncer de pulmón llamado "cáncer de pulmón microcítico"
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10041069
    E.1.2Term Small cell lung cancer limited 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 monotherapy as well as durvalumab in combination with tremelimumab therapy compared to placebo in terms of PFS.
    - To assess the efficacy of durvalumab in combination with tremelimumab therapy compared to placebo in terms of OS.
    -Evaluar la eficacia de la monoterapia con durvalumab y con durvalumab en combinación con tremelimumab en comparación con el placebo en términos de SSP.
    - Evaluar la eficacia de durvalumab en combinación con el tratamiento con tremelimumab en comparación con el placebo en términos de SG
    E.2.2Secondary objectives of the trial
    To Assess :
    - the efficacy of durvalumab compared to placebo in terms of OS.
    - the efficacy of durvalumab and durvalumab and tremelimumab compared to placebo in terms of ORR, PFS18a, PFS24a, TTDM, OS24, OS36, and PFS2.
    - the efficacy of durvalumab and tremelimumab compared to durvalumab in terms of PFS, OS and ORR,,
    - disease-related symptoms and HRQoL in patients treated with durvalumab or durvalumab and tremelimumab compared to placebo using the EORTC QLQ-C30 v3 and QLQ-LC13.
    - the PK of durvalumab and durvalumab and tremelimumab.
    To Investigate:
    - the immunogenicity of durvalumab and durvalumab and tremelimumab.
    - the relationship between a patient’s tumor mutational burden (TMB) measured in tumor and/or blood and efficacy outcomes with mono and combination therapy.
    - safety and tolerability of durvalumab and durvalumab and tremelimumab compared to placebo
    Para evaluar:
    - la eficacia de durvalumab en comparación con el placebo en términos de SG.
    - la eficacia de durvalumab y durvalumab y tremelimumab en comparación con placebo en términos de TRO, SSP18a, SSP24a, TTDM, SG24, SG36 y SSP2
    - la eficacia de durvalumab y tremelimumab en comparación con durvalumab en términos de SSP, SG y TRO
    - los síntomas relacionados con la enfermedad y la CVRS en pacientes tratados con durvalumab o durvalumab y tremelimumab en comparación con placebo utilizando el QLQ-C30 y QLQ-LC13 de la EORTC
    - la FC de durvalumab y durvalumab y tremelimumab.
    Investigar:
    - la inmunogenicidad de durvalumab y durvalumab y tremelimumab.
    - la relación entre la carga mutacional tumoral de un paciente medida en el tumor y / o la sangre y los resultados de eficacia con terapia mono y combinada.
    - seguridad y tolerabilidad de durvalumab y durvalumab y tremelimumab en comparación con placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] i.e., patients whose disease can be encompassed within a radical radiation portal - Patients with Stage I to IIA disease must be medically inoperable.
    - Received 4 cycles of platinum-based chemotherapy concurrent with RT, which must be completed within 1 to 42 days prior to first dose of IP. The chemotherapy regimen must contain platinum and etoposide, as per local standard-of-care regimens.
    - The radiotherapy must have commenced no later than the end of Cycle 2 of chemotherapy and patients must have received a total dose of radiation of 60 to 66 Gy for standard QD radiation schedules or 45 Gy for hyperfractionated BID radiation schedules.
    - Patients must have achieved CR, PR, or SD and not have progressed following definitive, platinum-based, concurrent CRT.
    - World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment and randomization.
    - Provision of an archived tumour tissue block (or at least 15 newly cut unstained slides, where available) ≤3 years old, where such samples exist in a quantity sufficient to allow for analysis (refer to the Laboratory Manual for details).
    - A recent (≤3 months) tumour biopsy* (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk.
    - SCLC con enfermedad limitada en estadio I-III documentada histológica o citológicamente [T cualquiera, N cualquiera, M0], es decir, pacientes cuya enfermedad puede incluirse en un portal de radiación radical - Los pacientes con enfermedad de estadio I a IIA deben ser médicamente inoperables.
    -Haber recibido 4 ciclos de quimioterapia con base de platino concurrente con la RT, que deben completarse dentro de 1 a 42 días antes de la primera dosis de IP. El régimen de quimioterapia debe contener platino y etopósido, según los regímenes locales estándar de atención.
    - La radioterapia debe haber comenzado a más tardar al final del Ciclo 2 de quimioterapia y los pacientes deben haber recibido una dosis total de radiación de 60 a 66 Gy para programas de radiación QD estándar o 45 Gy para programas de radiación BID hiperfraccionados.
    - Los pacientes deben haber alcanzado CR, PR o SD y no haber progresado después de una TRC simultánea, basada en platino y definitiva.
    - Estado funcional (PS) de la Organización Mundial de la Salud (OMS) / Eastern Cooperative Oncology Group (ECOG) de 0 o 1 al momento de la inscripción y la randomización.
    - Provisión de un bloque de tejido tumoral archivado (o al menos 15 cortes puros recién cortados, cuando estén disponibles) ≤3 años, cuando dichas muestras existan en una cantidad suficiente para permitir el análisis (consulte el Manual de laboratorio para obtener más información).
    - Una biopsia de tumor reciente (≤3 meses) (tomada después de completar la terapia más reciente) es un requisito opcional, siempre que un procedimiento de biopsia sea técnicamente viable y no se asocie con un riesgo clínico inaceptable.
    E.4Principal exclusion criteria
    - Extensive-stage SCLC.
    - Mixed SCLC and NSCLC histology.
    - Brain metastases or spinal cord compression. All patients will have an MRI (preferred) or CT, preferably with IV contrast of the brain, prior to study entry.
    - Patients who received sequential chemoradiation therapy for LD-SCLC (no overlap of RT with chemotherapy).
    - Receipt of consolidation chemotherapy after radiation. (Treatment with etoposide and platinum after radiation is acceptable as 1 regimen for 1 to 2 cycles; chemotherapy regimens other than etoposide and platinum as consolidation are not permitted.)
    - Patients with Grade ≥2 pneumonitis from prior CRT
    - Active or prior documented autoimmune/inflammatory disorders, uncontrolled intercurrent illness or active infections
    - Prior exposure to immune-mediated therapy.
    - SCLC metastásica.
    - Histología mixta de SCLC y NSCLC.
    - Metástasis cerebrales o compresión de la médula espinal. Todos los pacientes realizarán una MRI (preferida) o una TC, preferiblemente con contraste intravenoso del cerebro, antes de ingresar al estudio.
    - Pacientes que recibieron terapia de quimiorradiación secuencial para LD-SCLC (sin superposición de RT con quimioterapia).
    - Recepción de quimioterapia de consolidación después de la radiación. (El tratamiento con etopósido y platino después de la radiación es aceptable como 1 régimen durante 1 a 2 ciclos; no se permiten regímenes de quimioterapia distintos del etopósido y platino como consolidación).
    - Pacientes con neumonitis de grado ≥2 de TRC anterior
    - Trastornos autoinmunes / inflamatorios activos o previamente documentados, enfermedades recurrentes no controladas o infecciones activas
    - Exposición previa a la terapia inmunomediada.
    E.5 End points
    E.5.1Primary end point(s)
    - PFS using BICR assessments according to RECIST 1.1
    - OS
    - SSP utilizando evaluaciones BICR según RECIST 1.1
    - SG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - PFS: On-study tumor assessments begin at baseline, then occur q8w ± 1w for the first 72 weeks (relative to the date of randomization), followed by q12w ±1w until up to 96 weeks relative to the date of randomization, and then q24w ±1w thereafter until RECIST 1.1-defined radiological progression, plus one follow-up scan
    - OS: every 4 weeks during treatment period at least every 8 weeks (±2 weeks) following treatment discontinuation
    - OS and PFS will be made periodically until end of study.
    SSP: las evaluaciones de tumores en el estudio comienzan al inicio, luego ocurren c8s ± 1s durante las primeras 72 semanas (en relación con la fecha de la randomización), seguidas de c12s ± 1s hasta 96 semanas en relación con la fecha de la randomización, y luego q24s ± 1s después hasta la progresión radiológica evaluada por RECIST 1.1, más una exploración de seguimiento
    - SG: cada 4 semanas durante el período de tratamiento al menos cada 8 semanas (± 2 semanas) después de la interrupción del tratamiento
    - SG y SSP se realizarán periódicamente hasta el final del estudio.
    E.5.2Secondary end point(s)
    - OS
    - ORR, PFS18, PFS24, and TTDM using BICR assessments according to RECIST 1.1, OS24 and OS36, PFS2
    - PFS and ORR using BICR assessments according to RECIST 1.1, OS
    - EORTC QLQ-C30 and QLQ-LC13: change in symptoms, functioning, and global health status/QoL
    - Concentration of durvalumab and tremelimumab in serum (such as peak concentration and trough; sparse sampling)
    - Presence of ADA for durvalumab and tremelimumab (confirmatory results: positive or negative)
    - TMB relative to response/efficacy outcomes (ORR, PFS, and OS)
    - Safety assessment: AEs; laboratory findings including clinical chemistry, hematology, urinalysis; physical examinations; vital signs including blood pressure and pulse; and electrocardiograms
    SG
    - TRO, SSP18, SSP24 y TTDM utilizando evaluaciones BICR de acuerdo con RECIST 1.1, SG24 y SG36, SSP2
    - SSP y TRO utilizando evaluaciones BICR de acuerdo con RECIST 1.1, SG
    - EORTC QLQ-C30 y QLQ-LC13: cambio en los síntomas, el funcionamiento y el estado de salud global / QoL
    - Concentración de durvalumab y tremelimumab en suero (como la concentración máxima y la depresión; muestreo escaso)
    - Presencia de ADA para durvalumab y tremelimumab (resultados confirmatorios: positivos o negativos)
    - TMB en relación con los resultados de respuesta / eficacia (ORR, SSP y SG)
    - Evaluación de la seguridad: EA; resultados de laboratorio que incluyen química clínica, hematología, análisis de orina; exámenes físicos; signos vitales que incluyen presión arterial y pulso; y electrocardiogramas
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ORR, PFS18, PFS24, TTDM, PFS. ORR: tumor assessments begin at baseline, then q8w±1w for the first 72 weeks (relative to the date of randomization), followed by q12w±1w until up to 96 weeks , and then q24w±1w thereafter until RECIST 1.1 radiological progression, plus one follow-up scan.
    - OS: Every 4 weeks during treatment, at least every 8 weeks (±2 weeks) following IP discontinuation
    - EORTC QLQ-C30, QLQ-LC13: Every 4 weeks (±3 days) relative to randomization until study termination or death
    - PK at C1 (post dose) and C2, C5, C26 (pre dose) and week 12 post IP discontinuation
    - ADA at C1, C5, C26 (pre dose) and week 12 and 24 post IP discont
    - TMB at screening (tumor) and C1, C2, C3, C4, C5 (blood)
    - Safety: screening and each treatment vist and up to 12 weeks post treatment.
    SSP18, SSP4, TTDM, SSP, TRO:evaluaciones de tumores comienzan al inicio, luego c8s ± 1s durante las 1eras 72 semanas (s) en relación con fecha de aleatorización),seguidas de c12s ± 1s hasta 96s, y luego c4s± 1s hasta progresión radiológica RECIST 1.1, más exploración de seguimiento.
    - SG: cada 4 s durante tratamiento, (tto) al menos cada 8 s (± 2 s) después de interrupción de PI
    - EORTC QLQ-C30, QLQ-LC13: cada 4 s (± 3 días)relacionado con randomización hasta finalización del estudio o muerte
    - FC en C1 (post dosis)y C2, C5, C26 (pre dosis) y s12 después de suspensión IP
    - ADA en C1, C5, C26 (antes de la dosis) y en las s12 y 24 después de suspensión IP
    - TMB en la selección (tumor) y C1, C2, C3, C4, C5 (sangre)
    - Seguridad: etección y cada visita de ttoy hasta 12s tras tto.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Healthcare resource utilization
    Quality of life
    Tolerabilidad
    Utilización de recursos sanitarios
    Calidad de vida
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Belgium
    Canada
    China
    Czech Republic
    Germany
    India
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Taiwan
    Turkey
    United States
    Vietnam
    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 defined as the last expected visit/contact of the last patient undergoing the study.
    A patient is considered to have completed the study when he/she has completed his/her last scheduled visit or last scheduled procedure.
    El final del estudio se define como la última visita / contacto esperado del último paciente que realiza el ensayo
    Se considera que un paciente ha completado el estudio cuando ha completado su última visita programada o el último procedimiento programado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 390
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 210
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legal representative may provide consent on behalf of a subject incapable of giving consent personally, where permitted by local regulations.
    Un representante legal puede dar su consentimiento en nombre de un sujeto incapaz de dar su consentimiento personalmente, cuando lo permitan las regulaciones locales
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 600
    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 durvalumab to patients in the durvalumab monotherapy or durvalumab and tremelimumab combination therapy treatment groups up to the time that they progress, experience intolerable toxicity, or reach the maximum 24-month duration of treatment (26 doses/cycles), whichever occurs first.
    Después del análisis final, AstraZeneca continuará suministrando durvalumab con etiqueta abierta a los pacientes en los grupos de tratamiento de combinación con durvalumab monoterapia o durvalumab y tremelimumab hasta el momento en que progresen, experimenten una toxicidad intolerable o alcancen la duración máxima de tratamiento de 24 meses. (26 dosis / ciclos), lo que ocurra primero.
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 23:34:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA