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    Summary
    EudraCT Number:2015-004104-33
    Sponsor's Protocol Code Number:FKB238-002
    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:2021-02-15
    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 number2015-004104-33
    A.3Full title of the trial
    A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin¿ In 1st Line Treatment for Patients with Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer in Combination of Paclitaxel and Carboplatin
    Studio randomizzato, in doppio cieco, in parallelo per valutare l¿efficacia e la sicurezza di FKB238 vs. Avastin¿ in combinazione con paclitaxel e carboplatino nel trattamento di 1a linea di pazienti con carcinoma polmonare non a piccole cellule non squamoso in stadio avanzato/recidivante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of FKB238 and Avastin¿ in patients with advanced/recurrent non-squamous non-small cell lung cancer
    Valutazione di FKB238 e Avastin¿ in pazienti con carcinoma polmonare non a piccole cellule non squamoso in stadio avanzato/recidivante.
    A.3.2Name or abbreviated title of the trial where available
    AVANA
    AVANA
    A.4.1Sponsor's protocol code numberFKB238-002
    A.5.4Other Identifiers
    Name:INDNumber:122990
    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 SponsorCENTUS BIOTHERAPEUTICS LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportCentus Biotherapeutics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentus Biotherapeutics Limited
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1 Francis Crick Avenue
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailClinical-Trial@centusbio.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 name-
    D.3.2Product code FKB238
    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.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeFKB238
    D.3.9.4EV Substance CodeSUB16402MIG
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB16402MIG
    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/Recurrent Non Squamous Non-Small Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule non squamoso in stadio avanzato/recidivante.
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Carcinoma polmonare
    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 HLT
    E.1.2Classification code 10029664
    E.1.2Term Non-small cell neoplasms malignant of the respiratory tract cell type specified
    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 demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR
    Dimostrare l¿efficacia equivalente di FKB238 e Avastin, nella formulazione approvata nell¿Unione Europea (Avastin UE), quando usati in associazione a paclitaxel/carboplatino, misurata in base al tasso di risposta globale (ORR)
    E.2.2Secondary objectives of the trial
    To compare FKB238 and EU-Avastin through:
    - Overall response rate at week 19
    - Progression-free Survival
    - Overall Survival
    - Duration Of Response
    - Disease Control Rate
    To compare the safety of FKB238 and EU-Avastin
    To compare the ADAs produced by FKB238 and EU-Avastin
    To compare the serum trough concentration (Ctrough) of FKB238 and EU-Avastin
    Valutare FKB238 vs. Avastin UE in base a:
    - velocit¿ generale di risposta alla Settimana 19
    - sopravvivenza libera da progressione (PFS);
    - sopravvivenza generale (OS)
    - durata della risposta (DoR)
    - tasso di controllo della malattia (DCR).
    Valutare la sicurezza di FKB238 vs. Avastin UE.
    Valutare gli anticorpi antifarmaco (ADA) prodotti da FKB238 vs. Avastin UE.
    Valutare la concentrazione sierica minima (Cmin) di FKB238 vs. Avastin UE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients aged 18 years or older
    • Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
    • Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
    • Existence of at least 1 measurable lesion by response evaluation criteria
    • Adequate haematological, renal and liver function

    Other inclusion criteria may apply.
    •Pazienti di età =18 anni
    •Nuova diagnosi di NS-NSCLC in stadio avanzato (IV)/recidivante non precedentemente trattato con qualsiasi terapia oncologica sistemica per malattia metastatica.
    •Diagnosi istologicamente o citologicamente confermata di NS-NSCLC predominante
    •Presenza di almeno una lesione misurabile secondo i criteri di valutazione della risposta
    •Funzionalità ematologica, renale ed epatica adeguata

    Si applicano anche altri criteri di inclusione.
    E.4Principal exclusion criteria
    • Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumours and mixed adenosquamous carcinomas of predominantly squamous nature
    • Any unresolved toxicities from prior systemic therapy
    • Known sensitising EGFR mutations or EML4-ALK translocation positive mutations
    • Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
    • Known hypersensitivity to any active ingredients or any excipients of the IPs and combination chemotherapy
    • Use of prohibited concomitant medication
    • Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
    • Fertile men or women of childbearing potential not using adequate contraception

    Other exclusion criteria may apply.
    •Carcinoma polmonare a piccole cellule (SCLC) o combinazione di SCLC e NSCLC Tumori a cellule squamose e carcinomi adenosquamosi misti con componente squamosa predominante
    •Qualsiasi tossicità non risolta dalla precedente terapia sistemica
    •Mutazioni attivanti l’EGFR note o mutazioni positive per la traslocazione di EML4-ALK
    •Trattamento precedente con inibitori di VEGF (fattore di crescita endoteliale vascolare)
    •Ipersensibilità nota ai principi attivi o qualsiasi eccipiente degli IP e della chemioterapia di combinazione
    •Uso di terapie concomitanti proibite
    •Infezione nota da virus dell’epatite B, dell’epatite C o dell’immunodeficienza umana (HIV)
    •Uomini in grado di concepire o donne in età fertile che non utilizzano un metodo di contraccezione adeguato.

    Si applicano anche altri criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (by Response Evaluation Criteria [RECIST] v1.1) assessed as the rate of the best response (complete response [CR] or partial response [PR]).
    ORR (in base ai criteri RECIST v. 1.1) valutato come il tasso di risposta migliore (risposta completa [CR] o risposta parziale [PR]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization to study treatment discontinuation.
    Dalla randomizzazione all'interruzione del trattamento in studio.
    E.5.2Secondary end point(s)
    ¿ Overall response rate (ORR) (by RECIST v1.1) at week 19, defined as the rate of the best response of Complete Response (CR) or Partial
    Response (PR) assessed at week 19
    ¿ Progression-free Survival (PFS), defined as the time from
    randomisation to the first documented disease progression (PD) or
    death, whichever occurs first
    ¿ Overall Survival (OS), defined as the time from randomisation to death
    from any cause
    ¿ Duration Of Response (DOR), defined as the time from the first
    documented Partial Response (PR) or Complete Response (CR) (by
    RECIST v1.1) to the first documented objective PD or death, whichever
    occurs first
    ¿ Disease Control Rate (DCR), defined as the rate of CR, PR, Stable
    Disease (SD) (=6 weeks)
    ¿ Safety as evaluated through Adverse Events (AEs), vital signs,
    haematology, clinical chemistry, urinalysis, electrocardiogram (ECG),
    Eastern Collaborative Oncology Group Performance Status (ECOG PS),
    and physical examination
    ¿ Immunogenicity (presence of ADAs)
    ¿ Pharmacokinetics (PK) (Ctrough)
    ¿ Overall response rate (ORR) (RECIST v1.1) alla settimana 19, definite come la velocit¿ della risposta migliore o della Risposta Completa (CR) o Risposta Parziale (PR) valuata alla settimana 19 ¿PFS, definita come il tempo dalla randomizzazione alla prima PD documentata o al decesso, a
    seconda di quale evento si verifichi per primo.
    ¿OS, definita come il tempo dalla randomizzazione alla morte per qualsiasi causa.
    ¿DoR, definita come il tempo dalla prima PR o CR documentata (in base ai criteri RECIST v. 1.1) alla prima PD documentata o al
    decesso, a seconda di quale evento si verifichi per primo.
    ¿DCR, definita come il tasso di CR, PR, SD (=6 settimane).
    ¿La sicurezza sar¿ valutata in base a eventi avversi (AE), segni vitali, parametri ematologici ed ematochimici, esame delle urine,
    elettrocardiogramma, indice di performance ECOG ed esame obiettivo.
    ¿Farmacocinetica: Cmin
    ¿Immunogenicit¿: presenza di ADA
    - Framcocinetica (PK) (Ctrough)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ¿ PFS: from randomisation to the first documented disease progression
    (PD), death or data cut-off, whichever occurs first
    ¿ OS: from randomisation to death from any cause or data cut-off
    ¿ DOR: from the first documented Partial Response (PR) or Complete
    Response (CR) (by RECIST v1.1) to the first documented objective PD or
    death, whichever occurs first
    ¿ PFS: dalla randomizzazione alla prima PD documentata o al decesso, a
    seconda di quale evento si verifichi per primo.
    ¿OS: dalla randomizzazione alla morte per qualsiasi causa.
    ¿DoR: dalla prima PR o CR documentata (in base ai criteri RECIST v. 1.1) alla prima PD documentata o al decesso, a seconda di
    quale evento si verifichi per primo.
    ¿DCR, definita come il tasso di CR, PR, SD (=6 settimane).
    ¿La sicurezza sar¿ valutata dalla firma del consenso informato fino a ¿ includendo il 30-day-folloup dopo l'ultima dose di farmaco
    sperimentale.
    ¿Farmacocinetica: dalla randomizzazione alla fine del periodo di fllowup, decesso, lost to up, o data cut-off, qualunque avvenga
    per primo.
    ¿Immunogenicit¿: dalla randomizzazione alla fine del periodo di fllowup, decesso, lost to up, o data cut-off, qualu
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Georgia
    Japan
    Korea, Republic of
    Peru
    Philippines
    Russian Federation
    Serbia
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    Bulgaria
    Croatia
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Data cut-off which occurs within a minimum of 12 months after randomisation of the last patient enrolled.
    Il data cut-off avverr¿ ad un minimo di 12 mesi dalla randomizzazione dell'ultimo paziente arruolato.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 201
    F.4.2.2In the whole clinical trial 730
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After data cut-off, CT database will close and all patients will be unblinded. Patients receiving IP will be provided option of continuing IP if investigator believes patients are gaining clinical benefit. Sponsor will continue supply IP after data cut-off until either MA or benefit-risk profile does not support development of FKB238, or authority has deemed drug not approvable. Patients receiving Avastin will be provided drug continuously until MA is obtained and reimbursment is available.
    Dopo il data cut-off sar¿ chiuso il database della sperimentazione clinica e sar¿ aperto il cieco di tutti i pazienti. I pazienti che staranno ancora ricevendo il farmaco sperimentale avranno la possibilit¿ di continuare il trattamento se lo sperimentatore riterr¿ che il paziente ne sta traendo un beneficio clinico. Il promotore continuer¿ a fornire il farmaco sperimentale dopo il data cut-off fino all' autorizzazione all' immissione in commercio o finch¿ il profilo di rischio/beneficio non supp
    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 Decision2016-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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