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    Summary
    EudraCT Number:2018-000867-10
    Sponsor's Protocol Code Number:D933QC00001
    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:2020-11-04
    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 number2018-000867-10
    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)
    Studio internazionale multicentrico di fase III, in doppio cieco, randomizzato, controllato verso placebo, per valutare il trattamento con Durvalumab in monoterapia oppure il trattamento con Durvalumab e Tremelimumab in combinazione come terapia di consolidamento per pazienti affetti da Carcinoma Polmonare a Piccole Cellule (SCLC) con malattia limitata (LD) stadio I-III, che non hanno progredito in seguito a chemio-radioterapia concomitante (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
    Studio con Durvalumab + Tremelimumab, Durvalumab, e Placebo in pazienti affetti da Carcinoma Polmonare a Piccole Cellule con malattia limitata in stadio I-III, che non hanno progredito in seguito a chemio-radioterapia concomitante
    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.5.4Telephone number000000000000
    B.5.5Fax number000000000000
    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 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 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.3.10 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 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 injection
    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 (LDSCLC)
    Pazienti affetti da Carcinoma Polmonare a Piccole Cellule con malattia limitata (LD-SCLC) stadio I-III.
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "Small Cell Lung Cancer" (SCLC)
    Tipologia specifica di tumore polmonare chiamata "Carcinoma Polmonare a Piccole Cellule" (SCLC).
    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 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.
    - Valutare l’efficacia del Durvalumab in monoterapia e l’efficacia del Durvalumab in associazione con il Tremelimumab rispetto al placebo in termini di PFS.
    - Valutare l’efficacia del Durvalumab in associazione con il Tremelimumab rispetto al placebo in termini di OS.
    E.2.2Secondary objectives of the trial
    To Assess:
    a) the efficacy of durvalumab compared to placebo in terms of OS.
    B) the efficacy of durvalumab and durvalumab and tremelimumab compared to placebo in terms of ORR, PFS18a, PFS24a, TTDM, OS24, OS36, and PFS2.
    c) the efficacy of durvalumab and tremelimumab compared to durvalumab in terms of PFS, OS and ORR,
    d) 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.
    e) the PK of durvalumab and durvalumab and tremelimumab.
    f) the immunogenicity of durvalumab and durvalumab and tremelimumab.
    g) the relationship between a patient’s tumor mutational burden (TMB) measured in tumor and/or blood and efficacy outcomes with mono and combination therapy.
    h) safety and tolerability of durvalumab and durvalumab and tremelimumab compared to placebo
    Valutare:
    a)efficacia della monoter a base di Durva rispetto al placebo in OS
    b)efficacia del Durva in monoter e della terap di Durva in associaz con Treme rispetto al placebo in ORR,PFS18a,PFS24a,TTDM,OS24,OS36ePFS2
    c)efficacia della terap a base di Durva in associaz con Treme rispetto al Durva in monoter in PFS,OSS,ORR
    d)sintomi correlati alla patolog e HRQoL in pz trattati con Durva in monoter o del Durva in associaz con Treme rispetto al placebo usando EORTC QLQ-C30 v3 e QLQ-LC13
    e)farmacocinetica (PK) del Durva in monoter e del Durva in associaz con Treme
    f)immunogen del Durva in monoter e del Durva in associaz con Treme
    g)relaz tra tasso di mutaz tumor del pz (TMB) misurato nel tumore e/o nel sangue e risultati di efficacia relativi alla monoter e della terapia combinata.
    h)profili di sicurezza e tollerab del Durva e della combinaz Durva e Treme rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) 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.
    b) 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.
    c) 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.
    d) Patients must have achieved CR, PR, or SD and not have progressed following definitive, platinum-based, concurrent CRT.
    e) World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment and randomization.
    f) 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).
    g) 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.
    a) SCLC con malattia limitata confermata attraverso esami istologici o citologici (Stage I-III SCLC [T qualsiasi , N qualsiasi, M0], vale a dire pazienti la cui malattia sia possibile includere all’interno di un unico volume di irradiazione ad intento radicale-Pazienti con malattia da Stadio I a IIA devono essere medicalmente inoperabili.
    b) Il paziente deve aver eseguito 4 cicli di chemioterapia a base di platino concomitante a Radio Terapia, completati entro 1 giorno e fino a 42 giorni prima della prima dose di farmaco di studio. La chemioterapia deve essere a base di platino ed etoposide, come previsto dal trattamento standard locale.
    c) la radioterapia deve essere iniziata non oltre la fine del Ciclo 2 di chemioterapia ed i pazienti devono aver ricevuto una dose complessiva di radiazioni da 60 a 66 Gy secondo programmi standard una volta al giorno o 45 Gy nel caso di radioterapia iperfrazionata eseguita due volte al giorno.
    d) i pazienti devono aver raggiunto Risposta Completa (CR) , Risposta Parziale (PR) o stabilità di malattia (SD) e non essere andati in progressione di malattia a seguito della Chemioradio terapia (CRT) concomitante a base di platino.
    e) Performance status (PS) del World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) di 0 o 1 all’arruolamento e alla randomizzazione.
    f) fornire un blocchetto di tessuto tumorale (o, se disponibili, almeno 15 slides tagliate recentemente non marcate) non più vecchio di 3 anni, qualora questi campioni fossero disponibili in quantità sufficienti per effettuare l’analisi (fare riferimento al Manuale di Laboratorio per i dettagli).
    g) una biopsia opzionale recente (non più vecchia di 3 mesi e prelevata una volta terminata la terapia più recente), qualora la biopsia sia tecnicamente fattibile e che la procedura non sia associata a un rischio clinico inaccettabile.
    E.4Principal exclusion criteria
    a) Extensive-stage SCLC.
    b) Mixed SCLC and NSCLC histology.
    c) 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.
    d) Patients who received sequential chemoradiation therapy for LD-SCLC (no overlap of RT with chemotherapy).
    e) 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.)
    f) Patients with Grade =2 pneumonitis from prior CRT
    g) Active or prior documented autoimmune/inflammatory disorders, uncontrolled intercurrent illness or active infections
    h) Prior exposure to immune-mediated therapy.
    a) stadio esteso di SCLC
    b) istologia del tumore mista tra SCLC ed NSCLC
    c) metastasi cerebrali o compressione del midollo spinale. Tutti i pazienti dovranno eseguire una risonanza magnetica (è preferita) o una tomografia computerizzata, preferibilmente con mezzo di contrasto endovenoso per l’encefalo, prima di essere trattati con il farmaco di studio.
    d) pazienti che hanno ricevuto chemioterapia e radioterapia sequenziale per la LD-SCLC (senza sovrapposizione tra chemioterapia ed RT)
    e)Pazienti che hanno ricevuto chemioterapia di consolidamento dopo la radioterapia (Il trattamento con etoposide e platino dopo la radioterapia è accettabile come 1° regime da 1 a 2 cicli; regimi di chemioterapia di consolidamento diversi da etoposide e platino non sono permessi).
    f) pazienti con polmonite di grado 2 dovuta a precedente CRT
    g) patologie infiammatorie o autoimmuni in atto o precedentemente contratte
    h) esposizione precedente a terapia immuno-mediata.
    E.5 End points
    E.5.1Primary end point(s)
    - PFS using BICR assessments according to RECIST 1.1
    - OS
    - PFS usando valutazioni BICR in base ai criteri RECIST 1.1
    - OS
    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.
    - PFS: la valutazione del tumore in studio effettuata al baseline, poi effettuata ogni 8 settimane (q8w) ± 1 settimana (w) per le prime 72 settimane (a partire dalla data di randomizzazione), poi ogni 12 settimane (q12w) ±1w sino alla settimana 96 a partire dalla data di randomizzazione, e successivamente ogni 24 settimane q24w ±1w sino a progressione radiologica secondo RECIST 1.1, insieme ad una tac di follow-up.
    - OS: ogni 4 settimane durante il periodo di trattamento ed almeno ogni 8 settimane (±2 settimane) a seguito della discontinuazione del trattamento
    - OS e PFS: saranno effettuati periodicamente sino alla fine dello studio
    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
    - OS;
    - ORR, PFS18, PFS24, TTDM usando valutazioni BICR in base ai criteri RECIST 1.1, OS24 ed OS36, PFS2
    - PFS ed ORR usando valutazioni BICR in base ai criteri RECIST 1.1, OS
    - EORTC QLQ-C30 e QLQ-LC13: variazioni della sintomatologia, del funzionamento fisico, dello stato di salute generale/QoL
    - Concentrazione di Durvalumab e Tremalimumab nel siero (come il picco più alto e più basso di concentrazione ; campionamento ridotto).
    - Presenza di anticorpi anti-farmaco (acronimo ADA) per Durvalumab e Tremelimumab (risultati di conferma: positivi o negativi).
    - TMB relativo ai risultati di risposta/efficacia (ORR, PFS ed OS)
    - Valutazioni di sicurezza: Eventi Avversi, risultati di laboratorio compresi i risultati ematochimici e delle urine; esame obiettivo; segni vitali inclusa la pressione arteriosa e la frequenza cardiaca; ed elettrocardiogrammi.
    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 discontinutation
    - TMB at screening (tumor) and C1, C2, C3, C4, C5 (blood)
    - Safety: screening and each treatment vist and up to 12 weeks post treatment.
    -ORR,PFS18,PFS24,TTDM,PFS.ORR:valutaz iniz tumore al baseline,poi effett q8w±1per le prime72sett(dalla data di randomizz),poi da q12w±1w fino alla sett96e successiv a partire dalla q24w ±1w sino a progress radiologic secondo RECIST 1.1,con agg di1tac di follow-up
    -OS:ogni4sett durant il per di trattam ed almeno ogni 8sett(±2 sett)a seguito della discontinuaz del trattam
    -EORTC QLQ-C30 e QLQ-LC13: ogni 4sett(±3 gg)a partire dalla randomiz sino alla fine dello studio o alla morte
    -PK alC1(post dose)ed alC2,C5,C26(pre dose)ed alla sett12dopo la discontinuaz dell’farmaco di studio.
    -ADA alC1,C5,C26(pre dose),alla12sett ed alla24sett dopo la discont dell’IP
    -TMB allo screen(tumor)ed alC1,C2,C3,C4,C5(sangue)
    -Sicurez:allo screening e ad ogni visita di trattamento e fino a12sett dopo il trattam
    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
    Tollerabilità, utilizzo delle risorse sanitarie, qualità della vita
    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 concerned7
    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 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
    Argentina
    Belgium
    Canada
    China
    Czechia
    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
    Lo studio è considerato terminato quando l'ultimo paziente partecipante allo studio stesso avrà effettuato l'ultima visita prevista/l'ultimo contatto previsto. Lo studio può essere considerato portato a termine, e quindi completato, per quei pazienti che hanno effettuato l'ultima vista prevista o l'ultima procedura prevista.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 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 rappresentate legale potrà fornire il consenso al posto del paziente incapace di dare il consenso personalmente, ove permesso dalla normativa locale.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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.
    Dopo l'analisi finale, AstraZeneca continuerà a fornire il durvalumab open-label ai pazienti che assumevano il durvalumab in monoterapia o durvalumab e tremelimumab nella terapia combinata finchè per i soggetti non avvenga la progressione della malattia, sviluppino intolleranza e tossicità ai famraci, o raggiungano un massino di 24 mesi di trattamento (26 dosi/cicli), qualsiasi delle condizioni dovesse avvenire peri prima.
    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 Decision2019-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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