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    Summary
    EudraCT Number:2018-002572-41
    Sponsor's Protocol Code Number:D9103C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-27
    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 ConcernedItaly - Italian Medicines Agency
    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)
    Studio internazionale di fase III, randomizzato, placebo-controllato, in doppio cieco, multicentrico, di Durvalumab sequenziale alla radioterapia stereotassica corporea per il trattamento di pazienti con Tumore del Polmone Non a Piccole Cellule, non operabile, allo stadio I/II e linfonodo negativo (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
    Studio di Durvalumab o placebo somministrato dopo radioterapia a pazienti con stadio precoce del tumore al polmone non a piccole cellule
    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
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountrySweden
    B.5.4Telephone number000000
    B.5.5Fax number000000
    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.3.10 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Cellcept 250mg Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCellcept 250mg Capsules
    D.3.2Product code [Cellcept 250mg Capsules]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmycophenolate mofetil
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namemycophenolate mofetil
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 Yes
    D.2.1.1.1Trade name Remicade 100mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRemicade 100mg powder for concentrate for solution for infusion
    D.3.2Product code [Remicade 100mg powder for concentrate for solutio
    D.3.4Pharmaceutical form Powder 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 INNInfliximab
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameInfliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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
    Pazienti con tumore al polmone non a piccole cellule al I/II stadio, non operabile, linfonodo negativo
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "Non-Small Cell Lung Cancer"
    Tipologia specifica di tumore polmonare chiamata "Carcinoma Polmonare Non a Piccole Cellule" (NSCLC).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    Valutare l’efficacia della monoterapia a base di Durvalumab rispetto al placebo in termine di PFS nei pazienti con T1c a T3N0M0 (NSCLC)
    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 in patients with subset of T1-T3N0 NSCLC
    To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS in patients with Stage I/II NSCLC
    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
    Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termine di PFS nei pazienti con NSCLC al I/II stadio
    Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termine di OS in pazienti con subset T1-T3N0 (NSCLC).
    Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di OS in paz con NSCLC al I/II stadio.
    Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di mortalità specifica per tumore al polmone
    Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di PFS24, TTP, TTDM ePFS2
    Valutare la farmacocinetica (PK) di Durvalumab
    Valutare l’immunogenicità di Durvalumab
    Valutare i sintomi e QOL relativa alla salute nei pazienti trattati con la monot a base di durvalumab rispetto al placebo utilizzando il EORTC QLQ-C30
    Valutare i profili di sicurezza e di tollerabilità della monoterapia a base di Durvalumab rispetto al placebo dopo la somministrazione di 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. Submission of available tumor tissue sample
    8. Adequate organ and marrow function required
    9. Patients with central or peripheral lesions are eligible
    10. Staging studies must be done within 10 weeks before randomization
    11. Pulmonary Function Testing within 12 weeks of randomization
    12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with radiation, surgery only, or surgery with adjuvant chemotherapy in whom all treatments completed >1 year prior to randomization are eligible.
    1. Età =18 anni
    2. NSCLC Stadio I / II confermato attraverso esame istologico o citologico, con stadiazione clinica I/II linfonodo negativo e grado di malattia compreso tra T1 e T3N0M0 candidati a ricevere il trattamento con radioterapia sterotassica corporea (SBRT).
    Pazienti che sono clinicamente inoperabili o che sono clinicamente operabili ma che hanno rifiutato la chirurgia o che hanno scelto la SBRT come terapia definitiva
    3. Completamento della SBRT (trattamento standard) come trattamento definitivo prima della randomizzazione
    4. Performance status (PS) del World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) di 0, 1 o 2 all’arruolamento ed alla randomizzazione
    5. Aspettativa di vita di almeno 12 settimane
    6. Peso corporeo >30 kg
    7. Consegna di un campione disponibile del tumore
    8. Adeguata funzionalità degli organi e del midollo osseo
    9. Sono eleggibili pazienti con lesioni centrali o periferiche
    10. Gli esami per determinare la stadiazione devono essere fatti entro 10 settimane prima della randomizzazione
    11. Test di funzionalità polmonare entro 12 settimane dalla randomizzazione
    12. Pazienti con una storia di metacronus in stadio I / II (T1-T3N0M0) NSCLC trattato in modo definitivo con radioterapia, solo chirurgia o chirurgia con chemioterapia adiuvante in cui tutti i trattamenti sono stati completati più di 1 anno prima alla randomizzazione sono eleggibili.
    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. Istologia del tumore mista a piccole cellule e non a piccole cellule
    2. Storia di trapianto allogenico
    3. Storia di un altro tumore primario senza eccezioni
    4. Storia di un'immunodeficienza primaria attiva
    5. Qualsiasi tossicità, non risolta dovuta alla SBRT di grado = 2 riportato dal National Cancer Institute (NCI) CTCAE, SBRT (Radioterapia stereotassica corporea)
    E.5 End points
    E.5.1Primary end point(s)
    PFS in patients with subset of T1-T3N0 by BICR
    PFS in pazienti con sottotipo T1 a T3N0 secondo BICR
    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.
    Le valutazioni del tumore si verificano 8 settimane dopo la randomizzazione, poi ogni 12 settimane fino alla 116ª settimana, poi ogni 16 settimane fino a 3 anni dopo la randomizzazione, e poi ogni 6 mesi fino a progressione
    E.5.2Secondary end point(s)
    - PFS in patients with T1 to T3N0 NSCLC
    - OS in patients with subset of T1-T3N0 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
    - PFS in pazienti con NSCLC da T1 a T3N0
    - OS in pazienti con sottotipo NSCLC da T1 a T3N0
    - OS in pazienti con NSCLC da T1 a T3N0M0
    - Mortalità del tumore al polmone
    - PFS24, TTP, and TTDM usando valutazioni BICR in base ai criteri RECIST 1.1
    - PFS2 con l’utilizzo della valutazione locale
    - Concentrazione di durvalumab nel sangue
    - Presenza di ADA per durvalumab
    - EORTC QLQ-C30: Cambiamenti nei sintomi, funzionalità e stato/qualità della vita globale
    - Sicurezza e Tollerabilità: eventi avversi, esami fisici, segni vitali, elettrocardiogrammi ed esami di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: from randomization until death due to any cause
    Lung cancer mortality: time from randomization until death due to lung cancer.
    PFS24: 24 months
    TTP: time from randomization until progression (excluding deaths)
    TTDM: time from randomization until death or distant metastasis
    PFS2: Time from randomization to second progression (local assessment)
    ADA: will be collected at Baseline, at Cycles: 1, 8, 14, 26 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
    OS: dalla randomizzazione fino alla morte per qualsiasi causa
    Mortalità per carcinoma polmonare: tempo dalla randomizzazione fino alla morte per tumore polmonare
    PFS24: 24 mesi
    TTP: tempo dalla randomizzazione fino alla progressione (esclusi i decessi)
    TTDM: tempo dalla randomizzazione alla morte o metastasi distanti
    PFS2: tempo dalla randomizzazione alla seconda progressione (valutazione locale)
    - ADA: saranno raccolti al baseline, ai cicli: 8, 14, 20, 26 successivamente dopo 3 e 6 mesi dopo il completamento/discontinuazione dal trattamento
    - EORTC QLQ-C30: Screening al baseline, settimana 2, 4, 6, 8, 12, 16 e 20 settimane dopo la randomizzazione, poi ogni 8 settimane fino 3 anni dopo la randomizzazione, successivamente ogni 6 mesi fino PFS2 -
    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
    Tollerabilità, Sintomi e qualità della vita correlati alla salute, Utilizzo di risorse sanitarie
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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 Information not present in EudraCT
    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
    China
    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 prevista / contatto dell'ultimo paziente sottoposto allo studio (ultimo soggetto all'ultima visita)
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 406
    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 rappresentante legale provvederà a fornire il consenso per un soggetto incapace di dare validamente il proprio consenso, come definito da leggi locali.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 706
    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.
    I paz randomiz alla monot con durva possono essere sottoposti a un max di 24 mesi di ritrattamento.
    I paz che interromp il trattam dopo PD come def da RECIST1.1 saranno seguiti per la sopravv.
    I paz che hanno interrotto il trattam a causa di tossicità o deterioram sintom, o hanno iniziato la succes terap antitum, saranno seguiti con valutaz del tum fino a PD def sec RECIST1.1 e verranno loro effett 1o+ scan di f-u fino a decesso (a sec dell'ev che si verif per primo) e seguiti per la sopravv
    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 Decision2019-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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