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   44334   clinical trials with a EudraCT protocol, of which   7366   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:2018-002220-16
    Sponsor's Protocol Code Number:D4194C00006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-29
    Trial results View 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 number2018-002220-16
    A.3Full title of the trial
    A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)
    Studio internazionale di fase II, in aperto, multicentrico per valutare la sicurezza di durvalumab in seguito a chemioterapia e radioterapia sequenziali in pazienti con carcinoma polmonare non a piccole cellule allo stadio III non resecabile (PACIFIC 6)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of durvalumab in patients with Non-Small Cell Lung Cancer who have not progressed after sequential chemoradiation therapy.
    Questo è uno studio di fase II, in aperto, multicentrico per valutare la sicurezza di una dose fissa di durvalumab in pazienti con carcinoma polmonare non a piccole cellule che non hanno mostrato progressione dopo chemioradioterapia.
    A.3.2Name or abbreviated title of the trial where available
    PACIFIC 6
    PACIFIC 6
    A.4.1Sponsor's protocol code numberD4194C00006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03693300
    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 pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@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.3.9.4EV 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT)
    Pazienti con carcinoma polmonare non a piccole cellule (NSCLC) allo stadio III non resecabile, che non hanno mostrato progressione dopo chemioradioterapia a base di platino.
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer
    Un tipo specifico di tumore al polmone
    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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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 safety and tolerability profile of durvalumab (MEDI4736) as defined by Grade 3 and Grade 4 TRAEs within 6 months from the initiation of durvalumab (MEDI4736) treatment.
    Valutare il profilo di sicurezza e tollerabilità di durvalumab (MEDI4736) definito in base a TRAE di Grado 3 e Grado 4 entro 6 mesi dall’inizio del trattamento con durvalumab (MEDI4736)
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of durvalumab (MEDI4736) treatment in terms of PFS and OS.
    - To further assess the efficacy of durvalumab (MEDI4736) treatment in terms of ORR and DoR.
    - To assess the efficacy of durvalumab (MEDI4736) treatment in terms of lung cancer mortality.
    - To further assess the safety and tolerability profile of durvalumab (MEDI4736) treatment, including all AEs.
    - Valutare l’efficacia del trattamento con durvalumab (MEDI4736) in termini di PFS e OS
    - Valutare ulteriormente l’efficacia del trattamento con durvalumab (MEDI4736) in termini di ORR e DoR
    - Valutare l’efficacia del trattamento con durvalumab (MEDI4736) in termini di mortalità per tumore polmonare
    - Valutare ulteriormente il profilo di sicurezza e di tollerabilità del trattamento con durvalumab (MEDI4736), inclusi tutti gli EA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Genetic research (Appendix D of study protocol, dated 16 Jul 2018)

    Rationale and Objectives
    Genetic variation may impact a patient's response to therapy, susceptibility to, and severity and PD. Variable response to therapy may be due to genetic determinants that impact drug absorption, distribution, metabolism, and excretion; MOA of the drug; disease aetiology; and/or molecular subtype of the disease being treated. Therefore, where local regulations and IRB/IEC allow, a blood sample will be collected for DNA analysis from consenting patients.
    AstraZeneca intends to collect, analyse, and store DNA for genetic research to explore how genetic variations may affect clinical
    parameters, risk and prognosis of diseases, and the response to medications. Genetic research may lead to better understanding of diseases, better diagnosis of diseases or other improvements in health care and to the discovery of new diagnostics, treatments or medications.
    In addition, collection of DNA samples from populations with well
    described clinical characteristics may lead to improvements in the design
    and interpretation of clinical studies and, possibly, to genetically guided
    treatment strategies.
    All patients will be asked to participate in this genetic research.
    Participation is voluntary and if a patient declines to participate there
    will be no penalty or loss of benefit. The patient will not be excluded
    from any aspect of the main study.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Ricerca genetica (Appendix D del protocollo in studio datato 16 luglio 2018)

    Razionale e obiettivi
    La variazione genetica può influire sulla risposta del paziente alla terapia, alla suscettibilità e alla gravità e alla PD. La risposta variabile alla terapia può essere dovuta a determinanti genetici che influenzano l'assorbimento, la distribuzione, il metabolismo e l'escrezione dei farmaci; meccanismo d’azione del farmaco; eziologia della malattia; e / o sottotipo molecolare della malattia da trattare. Pertanto, laddove le normative locali e IRB / IEC lo consentono, verrà prelevato un campione di sangue per l'analisi del DNA da pazienti consenzienti.
    AstraZeneca intende raccogliere, analizzare e archiviare il DNA per la ricerca genetica per esplorare in che modo le variazioni genetiche possono influenzare i parametri clinici, il rischio e la prognosi delle malattie e la risposta ai farmaci. La ricerca genetica può portare a una migliore comprensione delle malattie, a una migliore diagnosi delle malattie o ad altri miglioramenti nell'assistenza sanitaria e alla scoperta di nuove diagnosi, trattamenti o farmaci.
    Inoltre, la raccolta di campioni di DNA da popolazioni con caratteristiche cliniche ben descritte può portare a miglioramenti nella progettazione e interpretazione di studi clinici e, possibilmente, in strategie di trattamento guidate geneticamente.
    A tutti i pazienti verrà chiesto di partecipare a questa ricerca genetica.
    La partecipazione è volontaria e se un paziente rifiuta di partecipare non ci sarà penalità o perdita di beneficio. Il paziente non sarà escluso da alcun aspetto dello studio principale.
    E.3Principal inclusion criteria
    - Informed consent as detailed in the protocol.
    - 18 years or older at the time of signing the ICF.
    - Histologically-or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
    - Receipt of sCRT which must have been completed within 42 days prior to first IP dose administration in the study as defined in the protocol.
    - Patients must not have progressed following platinum-based sCRT, as per Investigator-assessed RECIST 1.1 criteria as defined in the protocol.
    - Must have a life expectancy of at least 12 weeks at enrolment.
    - WHO/ECOG PS =2.
    - Adequate organ and marrow function at enrolment as defined in the protocol.
    - Body weight >30 kg at enrolment and first IP dose administration.
    - Male or female.
    - Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Age-specific requirements are detailed in the protocol.
    - Consenso informato come specificato nel protocollo.
    - 18 anni o più al momento della firma dell'ICF.
    - NSCLC istologicamente o citologicamente documentato con malattia di stadio III localmente avanzata e non resecabile (secondo il Manuale di stadiazione IASLC versione 8 [IASLC 2016]). Tomografia ad emissione di positroni (PET) / TC, risonanza magnetica cerebrale ed ecografia endobronchiale con biopsia sono altamente consigliate alla diagnosi.
    - Ricevimento di sCRT che deve essere stato completato entro 42 giorni prima della somministrazione della prima dose di farmaco nello studio come definito nel protocollo.
    - I pazienti non devono aver progredito a seguito di sCRT a base di platino, secondo i criteri RECIST 1.1 valutati dallo sperimentatore come definiti nel protocollo.
    - Deve avere un'aspettativa di vita di almeno 12 settimane al momento dell'iscrizione.
    - WHO / ECOG PS =2.
    - Adeguata funzionalità dell'organo e del midollo all'arruolamento come definito nel protocollo.
    - Peso corporeo> 30 kg all'arruolamento e alla prima somministrazione della dose.
    - Maschio o femmina.
    - Evidenza dello stato post-menopausale o test di gravidanza negativo urinario o sierico per pazienti in pre-menopausa femminile. Le donne saranno considerate in post-menopausa se sono state amenorroiche per 12 mesi senza una causa medica alternativa. I requisiti specifici dell'età sono dettagliati nel protocollo.
    E.4Principal exclusion criteria
    - Patients with locally-advanced NSCLC whose disease has progressed following platinum-based sCRT.
    - Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumours.
    - Mixed small-cell lung cancer and NSCLC histology.
    - History of allogeneic organ transplantation.
    - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). Exceptions to this criterion are defined in the protocol.
    - Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.

    - History of another primary malignancy except for:
    -- Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence.
    -- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    -- Adequately treated carcinoma in situ without evidence of disease.

    - History of leptomeningeal carcinomatosis.
    - History of active primary immunodeficiency.
    - Active infection including tuberculosis, hepatitis B, hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Patients with a past or resolved hepatitis B virus (HBV) infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
    - Any unresolved toxicity of NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. More details to be found in the protocol.
    - Known allergy or hypersensitivity to durvalumab (MEDI4736) or any of the IP excipients.
    - Patients who have received cCRT for locally-advanced NSCLC, or who received sCRT with at least 2 concomitant CRT cycles. Prior surgical resection (ie, Stage I or II) is permitted.
    - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
    - Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
    - Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
    - Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. Exceptions to this criterion are detailed in the protocol.
    - Previous IP assignment in the present study.
    - Concurrent enrolment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study.
    - Participation in another clinical study with an IP during the 4 weeks prior to the first IP dose administration.
    - Prior randomisation or treatment in a previous durvalumab (MEDI4736) ± tremelimumab clinical study regardless of treatment arm assignment.
    For additional exclusion criteria please refer to study protocol.
    - Pazienti con NSCLC localmente avanzato la cui malattia è progredita dopo sCRT a base di platino.
    - Pazienti che hanno una malattia in considerazione per il trattamento chirurgico come parte del piano di cura, come Pancoast o tumori del solco superiore.
    - Istologia mista con tumore polmonare a piccole cellule e NSCLC.
    - Storia del trapianto di organi allogenici.
    - Disturbi autoimmuni o infiammatori documentati attivi o pregressi (compresa la malattia infiammatoria intestinale [es. Colite o morbo di Crohn], diverticolite [ad eccezione di diverticolosi], lupus eritematoso sistemico, sindrome di Sarcoidosi o sindrome di Wegener [granulomatosi con poliangioite, malattia di Graves , artrite reumatoide, ipofisite, uveite, ecc.)). Le eccezioni a questo criterio sono definite nel protocollo.
    - Malattie intercorrenti incontrollate, incluse ma non limitate a, infezioni in corso o attive, insufficienza cardiaca congestizia sintomatica, ipertensione non controllata, angina pectoris instabile, aritmia cardiaca, ILD, condizioni croniche GI gravi associate a diarrea o psichiatria
    situazioni di malattia / sociali che limiterebbero il rispetto dei requisiti dello studio, aumenterebbero notevolmente il rischio di incorrere in eventi avversi o compromettere la capacità del paziente di fornire un consenso informato scritto
    - Storia di un'altra neoplasia primaria tranne:
    -- Malignità trattata con intento curativo e con nessuna malattia attiva nota =5 anni prima della prima dose di IP e di basso potenziale rischio di recidiva.
    -- Tumore cutaneo non-melanoma adeguatamente trattato o lentigo maligna senza evidenza di malattia.
    -- Carcinoma adeguatamente trattato in situ senza evidenza di malattia.
    - Storia di carcinomatosi leptomeningea.
    - Storia di immunodeficienza primaria attiva.
    - Infezione attiva tra cui tubercolosi, epatite B, virus dell'epatite C (HCV) o virus dell'immunodeficienza umana (HIV). Sono eleggibili i pazienti con infezione da virus dell'epatite B (HBV) passati o risolti. I pazienti positivi per l'anticorpo dell'epatite C sono eleggibili solo se la PCR è negativa per acido ribonucleico HCV (RNA).
    - Qualunque tossicità irrisolta di grado NCI CTCAE =2 rispetto alla precedente terapia antitumorale ad eccezione dell'alopecia, della vitiligine e dei valori di laboratorio definiti nei criteri di inclusione. Si trovano maggiori dettagli nel protocollo.
    - Allergia nota o ipersensibilità al durvalumab (MEDI4736) o ad uno qualsiasi degli eccipienti del farmaco sperimentale.
    - Pazienti che hanno ricevuto cCRT per NSCLC localmente avanzato o che hanno ricevuto sCRT con almeno 2 cicli concomitanti di CRT. È consentita la precedente resezione chirurgica (cioè, stadio I o II).
    - Ricevuta di vaccino vivo attenuato nei 30 giorni precedenti la prima dose di IP.
    - Procedura chirurgica maggiore (secondo la definizione dello sperimentatore) entro 28 giorni prima della prima dose di IP.
    - Esposizione precedente alla terapia immuno-mediata, inclusi ma non limitati a, altri anticorpi anti-CTLA-4, anti-PD-1, anti-PD-L1 e anti-PD-L2, esclusi i vaccini antitumorali terapeutici.
    - Uso attuale o precedente di farmaci immunosoppressivi entro 14 giorni prima della prima dose di IP. Le eccezioni a questo criterio sono dettagliate nel protocollo.
    - Assegnazione di IP precedente nel presente studio.
    - Iscrizione concomitante in un altro studio clinico, a meno che non si tratti di uno studio clinico osservazionale o del periodo di follow-up di uno studio interventistico.
    - Partecipazione a un altro studio clinico con IP durante le 4 settimane precedenti la prima somministrazione di IP.
    - Precedente randomizzazione o trattamento in uno studio clinico con durvalumab (MEDI4736) ± tremelimumab indipendentemente dall'assegnazione del braccio di trattamento.
    Per ulteriori criteri di esclusione, si faccia riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Grade 3 or Grade 4 TRAEs
    TRAE di Grado 3 o Grado 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will receive IMP every 4 weeks (q4w) for a maximum of 24 months.

    Efficacy for all patients will be assessed every 8 weeks (q8w) for the first 12 months and every 12 weeks (q12w) thereafter, until disease progression; plus an additional follow-up scan is performed if clinically feasible. Additional scans can be completed per standard practice post disease progression.

    Patients who have discontinued treatment will be followed up for 90 days after IP discontinuation, and thereafter followed up with tumour assessments until RECIST 1.1-defined radiological PD plus an additional follow-up scan or until death (whichever comes first).
    I pazienti riceveranno IMP ogni 4 settimane (q4w) per un massimo di 24 mesi.

    L'efficacia per tutti i pazienti sarà valutata ogni 8 settimane (q8w) per i primi 12 mesi e ogni 12 settimane (q12w) successivamente, fino alla progressione della malattia; inoltre, se clinicamente possibile, viene eseguita un'ulteriore scansione di follow-up. Le scansioni aggiuntive possono essere completate secondo pratica standard dopo progressione della malattia.

    I pazienti che hanno interrotto il trattamento verranno seguiti per 90 giorni dopo la sospensione del IP e successivamente seguiti con le valutazioni tumorali fino alla PD radiologica definita secondo RECIST 1.1 più un'ulteriore scansione di follow-up o fino alla morte (a seconda dell'evento che si verifica per primo).
    E.5.2Secondary end point(s)
    - Median PFS according to RECIST 1.1 as assessed by the Investigator.
    - PFS12 and PFS24 according to RECIST 1.1 as assessed by the Investigator.
    - Median OS, OS12, OS24, and OS36.
    - ORR according to RECIST 1.1 as assessed by the Investigator.
    - DoR according to RECIST 1.1 as assessed by the Investigator.
    - Lung cancer mortality.
    - AEs, SAEs, AESIs, imAEs, physical examinations, vital signs including BP, pulse, temperature and respiratory rate, ECGs, and laboratory findings including clinical chemistry, haematology and urinalysis.
    - PFS mediana valutata dallo sperimentatore secondo i criteri RECIST 1.1
    - PFS12 e PFS24 mediane valutate dallo sperimentatore secondo i criteri RECIST 1.1
    - OS, OS12, OS24 e OS36 mediane
    - ORR valutato dallo sperimentatore secondo i criteri RECIST 1.1
    - DoR valutata dallo sperimentatore secondo i criteri RECIST 1.1
    - Mortalità per tumore polmonare
    - EA, SAE, AESI, imAE, esami obiettivi, segni vitali inclusi P.A., polso, temperatura e frequenza respiratoria, ECG e risultati di laboratorio incluse chimica clinica, ematologia e analisi delle urine
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will receive IMP every 4 weeks (q4w) for a maximum of 24 months.

    Efficacy for all patients will be assessed every 8 weeks (q8w) for the first 12 months and every 12 weeks (q12w) thereafter, until disease progression; plus an additional follow-up scan is performed if clinically feasible. Additional scans can be completed per standard practice post disease progression.

    Patients who have discontinued treatment will be followed up for 90 days after IP discontinuation, and thereafter followed up with tumour assessments until RECIST 1.1-defined radiological PD plus an additional follow-up scan or until death (whichever comes first).

    All patients in the study should be followed up for survival every 12 weeks until death, withdrawal of consent, or the end of the study.
    I pz riceveranno IMP ogni 4 sett.(q4w)per un max di 24 mesi.
    L'efficacia sarà valutata ogni 8 sett.(q8w)per i primi 12 mesi e ogni 12 sett.(q12w)successivamente,fino a progressione;se clinicamente possibile,viene eseguita un'ulteriore scansione di follow-up.Le scansioni aggiuntive possono essere completate secondo pratica standard dopo progressione.
    I pz che hanno interrotto il trattamento verranno seguiti per 90 giorni dopo la sospensione del IP e successivamente seguiti con valutazioni tumorali fino alla PD radiologica definita secondo RECIST 1.1 più un'ulteriore scansione di follow-up o fino a morte(a seconda dell'evento che si verifica per primo).
    Tutti i pz nello studio devono essere seguiti per sopravvivenza ogni 12 settimane fino a morte,ritiro del consenso o fine dello studio
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker; Quality of life
    Biomarker, 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA41
    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
    United States
    France
    Germany
    Italy
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the last visit of the last patient undergoing the study, i.e. LPLV.
    La conclusione dello studio è definita come ultima visita dell'ultimo paziente in studio, cioè LPLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 150
    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)
    If the Investigator determines that the patient still benefits from treatment with the IMP, AstraZeneca will continue to supply the IMP to patients up to the time that they discontinue the treatment for whatever reason (see protocol section 7.1 „Discontinuation of study drug“).
    Se lo Sperimentatore ritiene che il paziente stia ancora beneficiando del trattamento con il farmaco sperimentale, AstraZeneca continuerà a fornire il farmaco sperimentale ai pazienti fino al momento dell'interruzione del trattamento per qualsiasi motivazione (si faccia riferimento alla sezione 7.1 "Discontinuation of study drug" del protocollo).
    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 Decision2018-12-17
    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 StatusCompleted
    P.Date of the global end of the trial2023-03-30
    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-Mon May 05 15:56:57 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA