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   43974   clinical trials with a EudraCT protocol, of which   7312   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:2018-003973-82
    Sponsor's Protocol Code Number:FoRT05-BEAT
    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:2021-06-14
    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 number2018-003973-82
    A.3Full title of the trial
    Phase II randomized trial comparing atezolizumab versus atezolizumab plus bevacizumab as first-line treatment in PD-L1 high advanced non-small-cell lung cancer patients
    Studio randomizzato di fase II di confronto tra atezolizumab versus atezolizumab più bevacizumab come trattamento di prima linea in pazienti con sovraespressione di PD-L1 con carcinoma polmonare non a piccole cellule avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II randomized trial comparing atezolizumab versus atezolizumab plus bevacizumab as first-line treatment in PD-L1 high advanced non-small-cell lung cancer patients
    Studio randomizzato di fase II di confronto tra atezolizumab versus atezolizumab più bevacizumab come trattamento di prima linea in pazienti con sovraespressione di PD-L1 con carcinoma polmonare non a piccole cellule avanzato
    A.3.2Name or abbreviated title of the trial where available
    FoRT05-BEAT
    FoRT05-BEAT
    A.4.1Sponsor's protocol code numberFoRT05-BEAT
    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 (FORT)
    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 supportRoche S.p.A.
    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, trav. 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-mailbeat@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 Yes
    D.2.1.1.1Trade name TECENTRIQ - 1200 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 20 ML (60 MG/ML) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAtezolizumab
    D.3.2Product code [RO5541267/F03]
    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 INNAtezolizumab
    D.3.9.2Current sponsor codeAtezolizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBevacizumab
    D.3.2Product code [RO4876646]
    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 INNBEVACIZUMAB
    D.3.9.2Current sponsor codeBevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Advanced non-small-cell lung cancer
    Carcinoma polmonare non a piccole cellule avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced non-small-cell lung cancer
    Tumore al polmone non a piccole cellule di stadio avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    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 the combination of atezolizumab and bevacizumab improves overall survival (OS) over atezolizumab as single agent in untreated PD-L1 high metastatic NSCLC.
    Valutare se la combinazione di atezolizumab e bevacizumab aumenti la sopravvivenza globale (OS) rispetto all’atezolizumab in monoterapia in pazienti con elevata espressione di PD-L1 e con NSCLC metastatico non trattato.
    E.2.2Secondary objectives of the trial
    To evaluate response rate (RR), progression free survival (PFS) and safety profile of the combination versus the single agent.
    To evaluate whether the combination of atezolizumab and bevacizumab improves overall survival (OS) over single agent atezolizumab according to presence of bone and/or hepatic metastases, considering their potential predictive value.
    Valutare il tasso di risposta (RR), la sopravvivenza libera da progressione (PFS) e il profilo di sicurezza della combinazione rispetto alla monoterapia.
    Valutare se la combinazione di atezolizumab e bevacizumab aumenti la sopravvivenza globale (OS) rispetto alla monoterapia conatezolizumab in caso di presenza di metastasi ossee e / o epatiche, considerando il loro potenziale valore predittivo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically confirmed diagnosis of stage IV non-squamous NSCLC with no evidence of EGFR sensitizing mutations or ALK or ROS1 rearrangements.
    2) Availability of tumor tissue.
    3) 3) Evidence of high levels of PD-L1 expression evaluated with immunohistochemistry (=50% by 22C3 or SP263 or TC/IC 3 scoring by SP 142) .
    4) No previous chemotherapy. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy.
    5) ECOG performance status 0-1.
    6) Life expectancy > 3 months
    7) Age =18 years.
    8) Measurable disease, as defined by RECIST v1.1.
    9) Adequate hematologic and organ function, defined by the following laboratory results obtained within 28 days prior to randomization:
    o ANC = 1500 cells/µL without granulocyte colony-stimulating factor support
    o Platelet count = 100,000/µL without transfusion
    o Hemoglobin = 9.0 g/dL
    Patients may be transfused to meet this criterion
    o AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
    ¿ Patients with documented liver metastases: AST and/or ALT = 5 × ULN
    ¿ Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN.
    o Serum bilirubin = 1.25 × ULN
    o Patients with known Gilbert disease who have serum bilirubin level = 3 mg/dL may be enrolled
    o Calculated creatinine clearance (CRCL) = 45 mL/min or calculated CRCL must be = 60 mL/min
    10) Patient compliance to trial procedures.
    11) Written informed consent.
    1) Diagnosi istologica confermata di NSCLC non squamoso di stadio IV senza evidenza di mutazioni attivanti EGFR o riarrangiamenti di ALK o ROS1.
    2) Disponibilità di campione di tessuto tumorale.
    3) Evidenza di elevata espressione di PD-L1 rilevata con immunoistochimica (=50% con 22C3 o SP263 o TC/IC 3 scoring con SP 142) .
    4) Nessun precedente trattamento chemioterapico.
    I pazienti che hanno ricevuto, precedente chemioterapia neoadiuvante, adiuvante, radioterapia o chemioradioterapia con intento curativo per la malattia non metastatica,
    deve aver avuto un intervallo libero da trattamento di almeno 6 mesi dalla randomizzazione dall'ultima dose di chemioterapia e / o radioterapia.
    5) Performance status 0-1 (ECOG)
    6) Aspettativa di vita > 3 mesi
    7) Età =18 anni.
    8) Malattia misurabile in accordo ai criteri RECIST versione 1.1
    9) Adeguata funzionalità ematologica e d’organo adeguata, definita dai seguenti risultati di laboratorio ottenuti entro 28 giorni prima della randomizzazione
    o ANC = 1500 cell/ µL in assenza di supporto del fattore stimolante la colonia di granulociti
    o Conta piastrinica = 100,000/µL senza trasfusione
    o Emoglobina = 9.0 g/dL
    I pazienti possono essere trasfusi per soddisfare questo criterio:
    o AST, ALT, e fosfatasi alcalina = 2.5 × ULN, con le seguenti eccezioni:
    i. Pazienti con documentate metastasi epatiche: AST e/o ALT = 5 × ULN
    ii. Pazienti con documentate metastasi epatiche e osee: fosfatasi alcalina = 5 × ULN.
    o Bilirubina sierica = 1.25 × ULN
    o Pazienti con accertata sindrome di Gilbert che hanno livelli di bilirubina sierica = 3 mg/dL possono essere arruolati
    o Clearance della creatinina (CRCL) = 45 mL/min o CRCL calcolata deve essere = 60 mL/min
    10) Aderenza del paziente alle procedure di studio.
    11) Consenso informato scritto.
    E.4Principal exclusion criteria
    1. No tumor tissue available.
    2. PD-L1 expression < 50 % or PD-L1 expression unknown or not assessable
    3. Patient positive for EGFR mutations or ALK or ROS1 rearrangements.
    4. Patients with squamous histology or with specific contraindication to bevacizumab therapy.
    5. Previously treated with chemotherapy
    6. Concomitant radiotherapy or chemotherapy.
    7. Previous therapy with any checkpoint inhibitor.
    8. Pregnancy or lactating women who are pregnant, lactating, or intending to become pregnant during the study.
    9. Symptomatic brain metastases
    10. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression
    11. Leptomeningeal disease.
    12. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    13. Uncontrolled or symptomatic hypercalcemia
    14. Malignancies other than NSCLC within 5 years prior to randomization
    15. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    16. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells
    17. History of autoimmune disease
    18. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
    19. Positive test for HIV
    20. Patients with active hepatitis B or hepatitis C.
    21. Active tuberculosis
    22. Severe infections within 4 weeks prior to randomization
    23. Significant cardiovascular disease
    24. Major surgical procedure other than for diagnosis within 28 days prior to randomization
    25. Prior allogeneic bone marrow transplantation or solid organ transplant
    26. Administration of a live, attenuated vaccine within 4 weeks before randomization
    27. metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease
    28. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
    29. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization
    30. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
    31. Treatment with systemic immunostimulatory agents
    32. Treatment with systemic immunosuppressive medications
    33. Patients who have received acute, low-dose, systemic immunosuppressant medications
    34. The use of steroids are permitted only as inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiencyand corticosteroids for CT pre treatment.
    35. Inadequately controlled hypertension
    36. Prior history of hypertensive crisis or hypertensive encephalopathy
    37. Significant vascular disease
    38. History of hemoptysis (= one-half teaspoon of bright red blood per episode) within 1 month prior to randomization;
    39. Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, and clostazol
    40. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to randomization
    41. Prophylactic anticoagulation for the patency of venous access devices is allowed
    42. Prophylactic use of low-molecular-weight heparin
    43. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device,
    44. History of abdominal or tracheosphageal fistula or gastrointestinal perforation
    45. Serious, non-healing wound, active ulcer, or untreated bone fracture
    46. Proteinuria
    47. Known sensitivity to any component of bevacizumab
    1. Tessuto tumorale non disponibile.
    2. Espressione di PD-L1 TPS < 50 % o sconosciuta o non valutabile
    3. Pazienti positive alle mutazioni EGFR o riarrangiamenti di ALK or ROS1.
    4. Pazienti con istologia squamosa o che abbiano controindicazioni specifiche verso il bevacizumab.
    5. Precedente chemioterapia.
    6. Concomitante radioterapia o chemioterapia.
    7. Precedente terapia con qualsiasi inibitore di checkpoint.
    8. Donne in gravidanza o in allattamento
    9. Metastasi cerebrali sintomatiche;
    10. Compressione del midollo spinale non trattata
    11. Meningite neoplastica.
    12. Versamento pleurico incontrollato, versamento pericardico o ascite
    13. Ipercalcemia incontrollata o sintomatica
    14. Tumori maligni diversi da NSCLC nei 5 anni precedenti
    15. Storia di gravi reazioni allergiche, anafilattiche o di altre reazioni di ipersensibilità agli anticorpi chimerici o umanizzati o alle proteine di fusione
    16. Ipersensibilità nota o allergia ai biofarmaceutici prodotti in cellule di ovaio di criceto cinese
    17. malattie autoimmuni
    18. fibrosi polmonare idiopatica, polmonite organizzata,polmonite indotta da farmaci, polmonite idiopatica o evidenza di polmonite attiva evidenziata durante lo screening dalla TC del torace.
    19. Positività all'HIV
    20. Pazienti con epatite B attiva o C.
    21. Tubercolosi attiva
    22. Infezioni gravi
    23. Malattie cardiovascolari significative
    24. Chirurgia maggiore entro 28 giorni prima della randomizzazione
    25. Precedente trapianto di midollo osseo allogenico o di altri organi solidi.
    26. Somministrazione di un vaccino vivo attenuato
    27. disfunzioni metaboliche, sospetto di una malattia o di una condizione che renda controindicato l'uso di un farmaco sperimentale
    28. Terapia anticancro approvata
    29. Trattamento con qualsiasi altro agente sperimentale o la partecipazione a un altro studio clinico con intento terapeutico entro 28 giorni prima della randomizzazione
    30. Precedente trattamento con agonisti CD137 o con inibitori del checkpoint immunitario, o con anticorpi anti-PD-1 e anti-PD-L1.
    31. Trattamento con farmaci immunostimolatori ad uso sistemico (incluso tra gli altri l’IFNs, IL-2) entro 6 settimane o cinque emivite del farmaco, quale sia il più breve, prima della randomizzazione.
    32. Trattamento con farmaci immunosoppressivi ad uso sistemico entro 2 settimane prima della randomizzazione.
    33. pazienti che hanno ricevuto farmaci immunosoppressivi sistemici a bassa dose acuta possono essere arruolati nello studio dopo discussione e approvazione da parte del Medical Monitor
    34. Consentiti corticosteroidi per via inalatoria per il trattamento della malattia polmonare ostruttiva cronica, di mineralcorticoidi per pazienti con ipotensione ortostatica, corticosteroidi a basso dosaggio per insufficienza surrenalica e corticosteroidi per allergie ai mezzi di contrasto per la TAC.
    35. Ipertensione non adeguatamente controllata (definita come pressione sistolica >150 mmHg e/o pressione diastolica >100 mmHg)
    36. Precedente storia di crisi ipertensiva o encefalopatia ipertensiva
    37. Patologia vascolare significativa
    38. Storia di emottisi entro 1 mese precedente la randomizzazione; Evidenza di diatesi emorragica o coagulopatia
    39. Uso attuale o recente di aspirina o trattamento con dipyramidole, ticlopidina, clopidogrel e clostazolo
    40. Uso corrente di anticoagulanti orali a dose intera o parenterali o agenti trombolitici a scopo terapeutico
    41. E’ consentita la terapia anticoagulante profilattica per la pervietà dei dispositivi di accesso venoso
    42. È consentito l'uso profilattico di eparina a basso peso molecolare
    43. Biopsia o altra procedura chirurgica minore
    44. Storia di fistola addominale o tracheoesofagea o perforazione gastrointestinale entro 6 mesi prima della randomizzazione
    45. Ferita grave, non cicatrizzante, ulcera attiva o frattura ossea non trattata
    46. Proteinuria
    47. Sensibilità nota a componenti del bevacizumab
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS) rate at 18 months in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination
    Tasso di sopravvivenza generale (OS) a 18 mesi in pazienti trattati con atezolizumab in monoterapia rispetto a pazienti trattati con atezolizumab-bevacizumab in combinazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) will be calculated from the date of randomization to the date of death due to any cause.
    La sopravvivenza globale (OS) sarà calcolata dalla data della randomizzazione alla data del decesso per qualsiasi causa.
    E.5.2Secondary end point(s)
    Response rate (complete + partial responses); Progression-free survival; Overall survival according to presence of bone and/ or hepatic metastases
    Tasso di risposta RR (risposta completa + risposte parziali); Tasso di sopravvivenza libera da progressione (PFS); Tasso di sopravvivenza globale (OS) in base alla presenza di metastasi ossee e/o epatiche
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessment will be performed every 6 weeks during treatment and every 3 months after PD or until initiation of new systemic anti-cancer therapy, whichever occurs first, and at end of treatment; Tumor assessment will be performed every 6 weeks during treatment and every 3 months after PD or until initiation of new systemic anti-cancer therapy, whichever occurs first, and at end of treatment.; Overall survival (OS) will be calculated from the date of randomization to the date of death due to any cause.
    La valutazione di malattia sarà effettuata ogni 6 settimane durante il trattamento e ogni 3 mesi dopo PD o fino l’inizio di una nuova terapia sistemica anti-cancro (a seconda di quale si verifica prima) e alla fine del trattamento; La valutazione di malattia sarà effettuata ogni 6 settimane durante il trattamento e ogni 3 mesi dopo PD o fino l’inizio di una nuova terapia sistemica anti-cancro (a seconda di quale si verifica prima) e alla fine del trattamento.; La sopravvivenza globale (OS) sarà calcolata dalla data della randomizzazione alla data del decesso per qualsiasi causa.
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Atezolizumab in monoterapia
    Atezolizumab as single agent
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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
    Last patient last visit (LPLV): last follow-up visit for LPI
    Ultima visita ultimo paziente (LPLV): ultima visita di follow-up per l’ultimo paziente arruolato
    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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 state206
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 206
    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)
    From the last dose of medication to each patient will be asked to return to the hospital for a follow-up visit every three months for a year
    Dall'ultima dose di farmaco ad ogni paziente sarà chiesto di ritornare in ospedale per una visita di follow-up ogni tre mesi per un anno.
    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 Opinion2019-07-24
    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