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   43884   clinical trials with a EudraCT protocol, of which   7296   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:2018-003645-41
    Sponsor's Protocol Code Number:STARDUST
    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:2021-06-17
    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 number2018-003645-41
    A.3Full title of the trial
    Phase II trial evaluating the efficacy of durvalumab (MEDI4736) as second-line therapy in Non- Small-Cell Lung Cancer patients receiving concomitant steroids
    Studio di fase II che mira a valutare l’efficacia del Durvalumab (MEDI4736) come seconda linea di terapia nei pazienti con Carcinoma al Polmone Non a Piccole Cellule che ricevono terapia concomitante con steroidi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial evaluating the efficacy of durvalumab (MEDI4736) as second-line therapy in Non- Small-Cell Lung Cancer patients receiving concomitant steroids
    Studio di fase II volto a valutare l’efficacia del Durvalumab nei pazienti con tumore al polmone non a piccole cellule che assumano contemporaneamente steroidi
    A.3.2Name or abbreviated title of the trial where available
    STARDUST
    STARDUST
    A.4.1Sponsor's protocol code numberSTARDUST
    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 SponsorFONDAZIONE RICERCA TRASLAZIONALE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstrazeneca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo- traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailstardust@cr-technology.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.3.9.2Current sponsor codeDurvalumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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) 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 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.2.5The 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 namePrednisone
    D.3.2Product code [Prednisone]
    D.3.4Pharmaceutical form Tablet
    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 INNPREDNISONE
    D.3.9.2Current sponsor codePrednisone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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
    Non- Small-Cell Lung Cancer
    Carcinoma al polmone non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non- Small-Cell Lung Cancer
    Tumore al polmone non a piccole cellule
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10025122
    E.1.2Term Lung squamous cell carcinoma stage I
    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 whether concomitant administration of corticosteroids (10 mg/day of prednisone equivalent) reduces incidence of side effects without affecting response to durvalumab therapy in pretreated advanced or metastatic NSCLC as measured by ORR.
    Verificare se la somministrazione concomitante di corticosteroidi (10 mg/al giorno di Prednisone equivalente) riduca l’incidenza degli eventi avversi senza minacciare la risposta alla terapia con Durvalumab in pazienti pretrattati con NSCLC avanzato o metastatico, misurato come ORR.
    E.2.2Secondary objectives of the trial
    - To evaluate the clinical impact of the combined (durvalumab + prednisone) treatment in terms of overall survival (OS) and progression free survival (PFS)
    - To investigate the association with tumor biomarkers in tumor tissue or blood, including PD-L1 expression, tumor grading and tumor mutational burden (TMB)
    - To evaluate the clinical impact of the combined (durvalumab + prednisone) treatment in terms of overall survival (OS) according to presence of bone and liver metastases
    - Valutare l’impatto clinico del trattamento combinato (Durvalumab+Prednisone) in termini di Overall Survival (OS) e sopravvivenza libera da progressione (PFS)
    - Indagare l’associazione con i biomarcatori tumorali nel tessuto tumorale o sangue, tra cui l’espressione del PD-L1, il Tumor Grading ed il Tumor Mutational Burden (TMB)
    - Valutare l’impatto clinico della combinazione (Durvalumab+Prednisone) in termini di Overall Survival (OS) in accordo alla presenza di metastasi ossee ed epatiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adequate normal organ and marrow function as definedbelow:
    -Haemoglobin = 9.0g/dL
    -Absolute neutrophil count (ANC)1.0 x109/L
    -Platelet count = 100 x 109/L
    -Serum bilirubin = 1.5 x institutional upper limit of normal(ULN).
    -AST (SGOT)/ALT (SGPT) =2.5 x institution a lupper limit of normal unless liver metastases are present, in which case it must be =5xULN
    -Measured creatinine clearance (CL)> 40mL/minor Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24- hour urine collection for determination of creatinine clearance:
    Males:
    Creatinine CL (mL/min) = Weight (kg) x (140 – Age) 72 x serum creatinine (mg/dL)

    Females:
    Creatinine CL (mL/min) = Weight (kg) x (140–Age) x 0.85
    72 x serum creatinine (mg/dL)

    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. Women who are surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible. The following age specific requirments apply:
    - Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy orhysterectomy).
    - Women = 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonaltreatments,hadradiation-inducedmenopausewithlastmenses>1year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy orhysterectomy).
    3. Histological or cytological confirmed diagnosis of advanced or metastatic NSCLC with no evidence of EGFR mutations or ALK rearrangement.
    4. Previous platinum-based chemotherapy. Only one line of previous chemotherapy is allowed. Adjuvant or neoadjuvant chemotherapy is not considered a line of therapy if completed at least 6 months before trial inclusion
    5. Age > 18 years at time of studyentry.
    6. Performance Status 0-1(ECOG)
    7. Body weight>30kg
    8. Able of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
    9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    10. Must have a life expectancy of at least 12weeks
    1. Adeguata funzionalità d’organo e di midollo come definita di seguito:
    - Emoglobina = 9.0g/dL
    - Conta totale di neutrofili (ANC)1.0 x109/L
    - Piastrine = 100 x 109/L
    - Bilirubina sierica = 1.5 x ULN
    - AST (SGOT)/ALT (SGPT) =2.5 x ULN a meno che non siano presenti metastasi al fegato, in tal caso il valore deve essere =5xULN
    - Clearance della creatinine Misurata (CL)> 40mL/min o creatinine calcolata CL>40 mL/min mediante la formula Cockcroft-Gault (Cockcroft e Gault 1976) o mediante la raccolta delle urine delle 24 h per la determinazione della clearance della creatinina:
    Uomini:
    Creatinina CL (mL/min) = Peso(kg) x (140–Età)
    72 x creatinina nel siero (mg/dL)
    Donne:
    Creatinina CL (mL/min) = Peso (kg) x (140–Età) x 0.85
    72 x creatinina nel siero (mg/dL)
    2. Evidenza di stato post- menopausale o di negatività del test di gravidanza (urine o siero) nelle pazienti di sesso femminile in pre-menopausa. Le donne saranno considerate post-menopausali se sono in amenorrea per almeno 12 mesi senza una causa medica.
    Le donne chirurgicamente sterili (ad esempio per salpingectomia bilaterale, ovariectomia bilaterale o isterectomia complete) sono eleggibili.
    Si applicano i seguenti requisiti specifici per età:
    - Donne con età inferiore ai 50 anni saranno considerate post-menopausali se sono state in amenorrea per almeno 12 mesi o più dopo la cessazione di trattamenti ormonali esogeni e se hanno livelli di ormone luteinizzante e ormone follicolo-stimolante nel range post-menopausale o abbiano subito la sterilizzazione chirurgica (oophorectomia bilaterale o isterectomia).
    - Le donne di età = 50 anni sono considerate post-menopausali se sono state amenorroiche per 12 mesi o più dopo la cessazione di tutti i trattamenti ormonali esogeni, menopausa indotta da radiazioni con le ultime mestruazioni avvenute più di un anno prima, abbiano avuto una menopausa indotta da chemioterapia con le ultime mestruazioni avvenute più di un anno prima, o sottoposte a sterilizzazione chirurgica (ovariectomia bilaterale, salpingectomia bilaterale o isterectomia).
    3. Diagnosi istologica o citologica confermata di NSCLC avanzato o metastatico senza evidenza di mutazioni di EGFR o riarrangiamento di ALK.
    4. Precedente chemioterapia a base di platino. È consentita solo una linea di chemioterapia precedente. La chemioterapia adiuvante o neoadiuvante non è considerata una linea di terapia se completata almeno 6 mesi prima dell’arruolamento nel trial
    5. Età> 18 anni all’ingresso nello studio.
    6. Performance Status 0-1(ECOG)
    7. Peso > 30kg
    8. Capacità di fornire il consenso informato firmato che include la conformità con i requisiti e le restrizioni elencati nel modulo di consenso informato (ICF) e in questo protocollo. Consenso informato scritto e qualsiasi autorizzazione richiesta localmente ottenuta dal paziente/rappresentante legale prima di eseguire qualsiasi procedura relativa al protocollo, comprese le valutazioni di screening.
    9. Paziente disposto e in grado di rispettare il protocollo per la durata dello studio, compresi i trattamenti in corso e le visite programmate e gli esami incluso il follow-up.
    10. Aspettativa di vita di almeno 12 settimane
    E.4Principal exclusion criteria
    1. Participation in another clinical study with an investigational product
    2. Concurrent enrolment in another clinical study
    3. Any previous treatment with a checkpoint inhibitor
    4. 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 study drug and of low potential risk for recurrence
    • Adequately treated non-melanoma skin cancer or lentigomaligna without evidence ofdisease
    • Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer insitu.
    5. Receipt of the last dose of anticancer therapy 21 days prior to the first dose of study drug
    6. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions:
    - Intranasal, inhaled, topical steroids, or local steroid injections
    - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    - Steroids as premedication for hypersensitivity reactions
    7. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy
    - Patients with Grade =2 neuropathy will be evaluate donacase-by-case basis after consultation with the StudyPhysician.
    - Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
    8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
    9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
    10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.Note:Local surgery of isolated lesions for palliative intent is acceptable.
    11. History of allogenic organt ransplantation.
    12. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., 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]). The following are exceptions to this criterion:
    - Patients with vitiligo oralopecia
    - Patients with hypothyroidism stable on hormone replacement
    - Any chronic skin condition that does not require systemic therapy
    - Patients without active disease in the last 5 years may be included but only after consultation with the study physician
    - Patients with celiac disease controlled by diet alone
    13. Uncontrolled intercurrent illness
    14. History of leptomeningeal carcinomatosis
    15. History of active primary immune deficiency
    16. Active infection including tuberculosis,hepatitis B, hepatitis C,or human immunodeficiency virus.
    17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
    18. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
    19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
    20. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
    21. Judgment by the investigator that the patient is unsuitable to participate in the study
    22. Patient positive for EGFR mutations or ALK rearrangement
    23. No previous platinum-based chemotherapy or more than one line of chemotherapy for advanced or metastatic disease.
    24. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if adequately pretreated.
    25. Pregnancy or lactating
    1. Partecipazione in altri studi clinici con un prodotto sperimentale
    2. Arruolamento concomitante in altri studi clinici
    3. Qualsiasi trattamento precedente con un inibitore del checkpoint
    4. Storia di un’altra neoplasia primaria tranne:
    • Malignità trattata con intento curativo e assenza di malattia attiva conosciuta per più di 5 anni prima della prima dose di farmaco e con un basso potenziale di rischio di recidiva.
    • Tumore cutaneo non melanoma adeguatamente trattato o lentigo maligna senza evidenza di disagio.
    • Carcinoma adeguatamente trattato in situ senza evidenza di malattia
    5. Ricevimento dell'ultima dose di terapia antitumorale 21 giorni prima della prima dose del farmaco in studio.
    6. Uso attuale o precedente di farmaci immunosoppressivi entro 14 giorni prima della prima dose di Durvalumab. Fanno eccezione:
    - Iniezioni intranasali, inalate, topiche o iniezioni di steroidi locali (ad es. Iniezione intra-articolare)
    - corticosteroidi sistemici a dosi fisiologiche non superiori a 10 mg / die di Prednisone o suoi equivalenti
    - steroidi come premedicazione per reazioni di ipersensibilità (per esempio, premedicazione per TAC)
    7. Qualunque tossicità irrisolta NCI CTCAE Grado =2 rispetto alla precedente terapia antitumorale
    • I pazienti con neuropatia di grado =2 verranno valutati caso per caso dopo aver consultato il medico dello studio.
    • I pazienti con tossicità irreversibile che non si ritiene possa essere ragionevolmente esacerbata dal trattamento con durvalumab possono essere inclusi solo dopo aver consultato il medico dello studio.
    8. Qualsiasi chemioterapia concomitante, IP, terapia biologica o ormonale per il trattamento del cancro.
    9. Trattamento di radioterapia a più del 30% del midollo osseo o con un ampio campo di radiazioni entro 4 settimane dalla prima dose del farmaco in studio.
    10. Procedura chirurgica maggiore entro 28 giorni prima della prima dose di IP.
    11. Storia di trapianto di organi allogenici.
    12. 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, Sarcoidosi o sindrome di Wegener. Sono eccezioni a questo criterio:
    • Pazienti con vitiligine o alopecia
    • Pazienti con ipotiroidismo stabile con sostituzione ormonale
    • Qualsiasi condizione cronica della pelle che non richiede una terapia sistemica
    • Pazienti senza patologia attiva negli ultimi 5 anni possono essere inclusi ma solo dopo consultazione medica
    • Pazienti con malattia celiaca controllata soltanto tramite dieta.
    13. Malattie intercorrenti incontrollate
    14. Storia di carcinomatosi leptomeningea
    15. Storia di deficienza immunitaria primaria attiva
    16. Infezione attiva compresa tubercolosi, epatite B, epatite C o immunodeficienza umana.
    17. Ricevimento del vaccino vivo attenuato nei 30 giorni precedenti la prima dose di IP.
    18. Pazienti donne in gravidanza o in allattamento o pazienti maschi o femmine potenzialmente fertili che non siano disposti ad usare metodi contraccettivi dallo screening fino a 90 giorni dopo l'ultima dose di durvalumab in monoterapia.
    19. Allergia nota o ipersensibilità a uno qualsiasi dei farmaci in studio o ad uno qualsiasi degli eccipienti del farmaco in studio.
    20. Precedente randomizzazione o trattamento in uno studio clinico con durvalumab indipendentemente dall'assegnazione del braccio di trattamento.
    21. Giudizio dello sperimentatore secondo cui il paziente non è idoneo a partecipare allo studio ed è improbabile che il paziente rispetti le procedure, le restrizioni e i requisiti dello studio
    22. Paziente positivo per mutazioni di EGFR o riarrangiamento di ALK
    23. Nessuna precedente chemioterapia a base di platino o più di una linea di chemioterapia per malattia avanzata o metastatica.
    24. Metastasi cerebrali sintomatiche. Le metastasi cerebrali asintomatiche sono consentite se adeguatamente pretrattate.
    25. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    a) objective response rate (ORR), for the assessment of efficacy
    b) incidence of immune-related side effects: for the assessment of safety
    a) tasso di risposta obiettiva (ORR), per la valutazione dell'efficacia
    b) incidenza di effetti collaterali immuno-correlati: per la valutazione della sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessments will be performed every 8 weeks. Therapy will be given until disease progression, unacceptable toxicity or patient refusal.
    La valutazione di malattia sarà effettuata ogni 8 settimane. La terapia sperimentale sarà effettuata fino a progressione, tossicità inaccettabile o rifiuto del paziente.
    E.5.2Secondary end point(s)
    Overall survival rate (OS); Progression free survival rate (PFS); Biomarker analyses, which will be conducted on archival tumor tissue (TT) collected prior to trial therapy and on blood samples collected at enrolment and at disease progression. Biomarker analyses, which will be conducted on archival tumor tissue (TT) collected prior to trial therapy on enrolled patients. Biomarkers include PD-L1 expression, tumor grading and tumor mutational burden (TMB). Archival TT were tested for PD- L1 in local or central Lab according to Center facilities and using one of the approved immunohistochemistry (IHC) platform. Tumor tissue (paraffin-embedded blocks or at least five 10-micron slices) collection will be mandatory for tumor grading and tumor mutational burden (TMB) assessment. Tumor grading and its association with PD-L1 expression and drug efficacy will beassessed.
    Tasso di sopravvivenza globale (OS); Tasso di sopravvivenza libera da progressione (PFS); Analisi di biomarker, che saranno condotte su tessuto tumorale archiviato (TT) raccolto prima della terapia sperimentale e su campioni di sangue raccolti all’arruolamento e alla progressione di malattia. I biomarcatori includono l'espressione di PD-L1, la classificazione del tumore e il carico mutazionale del tumore (TMB). Il TT è testato per PD- L1 nel laboratorio locale o centrale secondo le attrezzature del Centro e utilizzando una delle metodiche di immunoistochimica (IHC) approvate. Il tessuto tumorale (incluso in blocchi di paraffina o almeno cinque fette da 10 micron) sarà obbligatorio per la valutazione del tumour grading e del carico mutazionale del tumore (TMB). La stadiazione del tumore e la sua associazione con l'espressione di PD-L1 e l'efficacia del farmaco saranno esaminate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease assessments will be performed every 8 weeks. Therapy will be given until disease progression, unacceptable toxicity or patient refusal.; Disease assessments will be performed every 8 weeks. Therapy will be given until disease progression, unacceptable toxicity or patient refusal.; Disease assessments will be performed every 8 weeks. Therapy will be given until disease progression, unacceptable toxicity or patient refusal.
    La valutazione di malattia sarà effettuata ogni 8 settimane. La terapia sperimentale sarà effettuata fino a progressione, tossicità inaccettabile o rifiuto del paziente.; La valutazione di malattia sarà effettuata ogni 8 settimane. La terapia sperimentale sarà effettuata fino a progressione, tossicità inaccettabile o rifiuto del paziente.; La valutazione di malattia sarà effettuata ogni 8 settimane. La terapia sperimentale sarà effettuata fino a progressione, tossicità inaccettabile o rifiuto del paziente.
    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 No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Yes
    E.8.1.7.1Other trial design description
    Prospettico in aperto a singolo braccio
    prospective, open label, single-arm
    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 concerned18
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 expected overall duration of the trial is 30 months
    La durata della sperimentazione sarà di 30 mesi (stima)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months30
    E.8.9.2In all countries concerned by the trial days10
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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)
    All patients will be followed for survival until the end of the study regardless of further treatments, or until the sponsor ends the study.
    Tutti i pazienti saranno seguiti per la sopravvivenza fino alla fine dello studio, indipendentemente da ulteriori trattamenti, o fino a quando lo sponsor termina lo studio.
    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 Decision2019-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA