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    Summary
    EudraCT Number:2018-002572-41
    Sponsor's Protocol Code Number:D9103C00001
    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:2019-01-24
    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 number2018-002572-41
    A.3Full title of the trial
    A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)
    Ensayo fase III, internacional, multicéntrico, doble ciego, aleatorizado y controlado con placebo de Durvalumab tras el tratamiento con radioterapia estereotáctica corporal (SBRT), para el tratamiento de pacientes con cáncer de pulmón no microcítico, estadio I/II no resecado, con ganglios linfáticos negativos (PACIFIC-4/RTOG-3515)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of durvalumab or placebo administered after radiation therapy for patients with early stage non-small cell lung cancer
    Ensayo de durvalumab o placebo administrado después de la radioterapia en pacientes en estadio temprano de cáncer de pulmón no microcítico.
    A.3.2Name or abbreviated title of the trial where available
    PACIFIC-4/RTOG-3515
    PACIFIC-4/RTOG-3515
    A.4.1Sponsor's protocol code numberD9103C00001
    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 pointStudy Information 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-mailinformation.center@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.3.9.3Other descriptive nameMEDI4736
    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.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 unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer
    Pacientes con cáncer de pulmón no microcítico en estadio I / II no resecado, con ganglios linfáticos negativos
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called “Non-Small Cell Lung Cancer”
    Tipo específico de cáncer de pulmón llamado “cáncer de pulmón 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 20.0
    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 assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS in patients with T1c to T3N0M0 NSCLC
    Evaluar la eficacia de durvalumab en monoterapia en comparación con el placebo en cuanto a la SSP en pacientes con CPNM T1c a T3N0M0
    E.2.2Secondary objectives of the trial
    To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS for all stage I/II NSCLC patients
    To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS
    To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of lung cancer-specific mortality
    To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS24, TTP, TTDM, and PFS2
    To assess the PK of durvalumab
    To investigate the immunogenicity of durvalumab
    To assess symptoms and health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30
    To assess the safety and tolerability profile of durvalumab monotherapy compared to placebo after administration of SBRT
    Evaluar la eficacia de durvalumab en monoterapia en comparación con placebo en cuanto a la SSP en pacientes con CPNM en estadio I/II.
    Evaluar la eficacia de durvalumab en monoterapia en comparación con placebo en la SG.
    Evaluar mejor la eficacia de durvalumab en monoterapia en comparación con placebo en cuanto a la mortalidad específica por el cáncer de pulmón.
    Evaluar mejor la eficacia de durvalumab en monoterapia en comparación con placebo en cuanto a SSP24, THP, THMD y SSP2.
    Evaluar la FC del durvalumab.
    Investigar la inmunogenicidad de durvalumab.
    Evaluar los síntomas y la calidad de vida relacionada con la salud en pacientes tratados con durvalumab en monoterapia en comparación con placebo mediante el cuestionario QLQ C30 de la EORTC.
    Evaluar el perfil de seguridad y tolerabilidad de durvalumab en monoterapia en comparación con el placebo tras la administración de SBRT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >/= 18 years
    2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
    3. Completion of SoC SBRT as definitive treatment prior to randomization
    4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
    5. Life expectancy of at least 12 weeks
    6. Body weight >30 kg
    7. Tumor sample required
    8. Adequate organ and marrow function required
    9. Patients with central or peripheral lesions are eligible
    10. Staging studies must be done within 8 weeks before randomization
    1. Edad >/= 18 años
    2. Estadio I a II de NSCLC documentado histológica o citológicamente, con estadio clínico I/III con ganglios linfáticos negativos (T1 a T3N0M0) y planeado recibir tratamiento definitivo con SBRT. Los pacientes pueden ser inoperables desde el punto de vista médico o ser médicamente operables y rechazar la cirugía o elegir someterse a SBRT (radioterapia estereotáctica corporal) como terapia definitiva
    3. Finalización del tratamiento definitivo con la SBRT del tratamiento de referencia antes de la randomización.
    4. Organización Mundial de la Salud (OMS) / Eastern Cooperative Oncology Group (ECOG) PS de 0, 1 o 2
    5. Esperanza de vida de al menos 12 semanas.
    6. Peso corporal> 30 kg
    7. Muestra de tumor requerida.
    8. Función adecuada de órgano y médula ósea requerida
    9. Los pacientes con lesiones centrales o periféricas son elegibles
    10. Los estudios de estadificación deben realizarse dentro de las 8 semanas anteriores a la aleatorización
    E.4Principal exclusion criteria
    1. Mixed small cell and non-small cell cancer histology
    2. History of allogeneic organ transplantation
    3. History of another primary malignancy with exceptions
    4. History of active primary immunodeficiency
    5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade >/=2 from
    SBRT (Stereotactic Body Radiation Therapy)
    1. Histología mixta de cáncer microcítico y no microcítico
    2. Antecedentes de traspante de órgano alogénico
    3. Antecedente de otra malignidad primaria con excepciones
    4. Antecedentes de inmunodeficiencia primaria activa
    5. Cualquier toxicidad no resuelta de grado >/=2 CTCAE según NCI (National Cancer Institute) tratada con SBRT (tratamiento con radioterapia estereotáctica corporal)
    E.5 End points
    E.5.1Primary end point(s)
    PFS in patients with T1c to T3N0M0 NSCLC by BICR according to RECIST 1.1
    Supervivencia libre de progresión en pacientes con CPNM en estadio precoz T1 T3N0M0 con radioterapia estereotáctica corporal (SBRT) según los criterios RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On-study tumor assessments occur 8 weeks after randomization, then every 12 weeks through week 116, then every 16 weeks through 3 years after randomization, then every 6 months thereafter until objective disease progression.
    Las valoraciones tumorales del ensayo se llevarán a cabo 8 semanas después de la randomización, posteriormente cada 12 semanas hasta la semana 116, después cada 16 semanas durante los 3 años posteriores a la randomización, y después cada 6 meses hasta la progresión objetiva de la enfermedad.
    E.5.2Secondary end point(s)
    PFS in patients with T1 to T3N0M0 NSCLC
    OS in patients with T1c to T3N0M0 NSCLC
    OS in patients with T1 to T3N0M0 NSCLC
    Lung cancer mortality
    PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1
    PFS2 using local assessment
    Concentration of durvalumab in blood
    Presence of ADA for durvalumab
    EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life
    Safety and tolerability: AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings
    Supervivencia libre de progresión en pacientes con CPNM T1 a T3N0M0
    Supervivencia global en pacientes con CPNM precoz T1 a T3N0M0
    Supervivencia global en pacientes con CPNM T1 a T3N0M0
    Mortalidad del cáncer de pulmón
    Supervivencia libre de progresión 24 meses después de la aleatorización, tiempo hasta la progresión, y tiempo hasta la muerte o metástasis a distancia según RECIST 1.1 evaluados mediante una revisión central independiente y enmascarada.
    Tiempo desde la aleatorización hasta la segunda progresión según valoración local
    Concentración de durvalumab en sangre
    Presencia de anticuerpos ADA para durvalumab
    EORTC QLQ-C30: cambios en síntomas, funcionamiento, y estado general de salud/calidad de vida
    Seguridad y tolerabilidad: acontecimientos adversos, exploración física, constantes vitales, electrocardiogramas, y hallazgos de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: from baseline to until death due to any cause
    PFS24 - at 24 months following randomization, TTP, TTDM: tumor assessments occur up to every 8 weeks 3 years after randomization, and then every 6 months thereafter
    Concentration of durvalumab in blood: at Week 4, 28, 52, 76 and week 100 and 3 Months after completed/discontinued study treatment
    ADA: will be collected at Baseline, at Week 28, 52, 76, 100 then months 3 and 6 after completed/discontinued study treatment
    EORTC QLQ-C30: Screening, at Baseline, Week 2, 4, 6, 8, 12, 16 and 20 weeks after randomization, then every 8 weeks until 3 years after randomization, then every 6 months until PFS2
    Safety and tolerability - from randomization until 3 months after treatment discontinuation
    SG: desde aleatorización hasta muerte por cualquier causa
    SLP24 a los 24 meses de aleatorización, THP, THMD: las valoraciones tumorales del ensayo se harán cada 8 semanas los 3 años siguientes a randomización, y después cada 6 meses
    Concentración de durvalumab en sangre: en las semanas 4, 28, 52, 76, 100, y 3 meses después de completar/retirar tratamiento del ensayo
    ADA: se recogerá en la basal, en semanas 28, 52, 76, 100 y en los meses 3 y 6 tras completar/retirar tto. del ensayo
    EORTC QLQ-C30: Aleatorización, basal, semanas 2, 4, 6, 8, 12, 16 y 20 posteriores a la randomización, después cada 8 semanas hasta los 3 años desde la randomización, después cada 6 meses hasta la segunda progresión
    Seguridad y tolerabilidad: desde randomización hasta 3 meses después de retirar el tratamiento
    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
    Symptoms and health-related quality of life
    Healthcare resource utilization
    Tolerabilidad
    Síntomas y Calidad de vida relativa a la salud
    Uso de los recursos sanitarios
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    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 expected visit/contact of the last patient undergoing the study (last subject last visit)
    Ultima visita/contacto previsto del ultimo paciente participante en el ensayo (última visita del último paciente).
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 paciente cuando este no esté capacitado a proporcionarlo personalmente, cuando lo permita la normativa local.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 239
    F.4.2.2In the whole clinical trial 630
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients randomized to durvalumab monotherapy may undergo up to 24 months of retreatment
    Patients who discontinue treatment after RECIST 1.1-defined PD will be followed up for survival
    Patients who have discontinued treatment due to toxicity or symptomatic deterioration, or who have commenced subsequent anticancer therapy, will be followed up with tumor assessments until RECIST 1.1-defined PD plus 1 or more follow-up scans or until death (whichever comes first) and followed for survival
    Los pacientes aleatorizados a monoterapia de durvalumab continuarán hasta 24 meses de retratamiento
    Seguimiento de supervivencia a pacientes retirados del tto después de PE definida por RECIST 1.1
    A pacientes retirados del tto debido a toxicidad o deterioro sintomático, o en tto subsecuente para el cáncer, se les hará seguimiento con valoraciones tumorales hasta PE según RECIST 1.1 y 1 o más escaner de seguimiento adicionales hasta la muerte (lo que ocurra antes) y seguimiento a supervivencia
    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 Decision2019-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-02
    P. End of Trial
    P.End of Trial StatusOngoing
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