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    Summary
    EudraCT Number:2015-004104-33
    Sponsor's Protocol Code Number:FKB238-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-09
    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 ConcernedSpain - AEMPS
    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
    Estudio aleatorizado, en doble ciego y de grupos paralelos, para comparar la eficacia y la seguridad de FKB238 frente a Avastin® como tratamiento de primera línea en pacientes con cáncer de pulmón no microcítico, no epidermoide, avanzado/en recidiva en combinación con paclitaxel y carboplatino
    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
    Evaluación de FKB238 y Avastin® en pacientes con cáncer de pulmón no microcítico, no epidermoide, avanzado/en recidiva
    A.3.2Name or abbreviated title of the trial where available
    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 number+34 913913443
    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.3.2Product 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.3.1Product nameAvastin
    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.3.9.3Other descriptive nameAvastin
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Cáncer de pulmón no microcítico, no epidermoide, avanzado/en recidiva
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    Demostrar la equivalencia, en cuanto a eficacia, entre el FKB238 y el producto Avastin aprobado en la Unión Europea (EU-Avastin) usados en combinación con paclitaxel/carboplatino, a juzgar por la tasa de respuesta global (TRG)
    E.2.2Secondary objectives of the trial
    To compare FKB238 and EU-Avastin through:
    - 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
    Comparar el FKB238 y EU-Avastin mediante:
    - Supervivencia sin progresión (SSP)
    - Supervivencia global (SG)
    - Duración de la respuesta (DDR)
    - Tasa de control de la enfermedad (TCE)
    Comparar la seguridad del FKB238 y EU-Avastin
    Comparar los anticuerpos contra el fármaco (ADA) provocados por el FKB238 y EU-Avastin
    Comparar la concentración sérica mínima (Cmin) de FKB238 y de EU-Avastin
    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.
    - Pacientes a partir de 18 años de edad
    -Con diagnóstico reciente de CPNM-NE avanzado (estadio IV) o en recidiva, para el cual no han recibido ningún tratamiento antineoplásico sistémico de la enfermedad metastásica, como quimioterapia, tratamiento biológico, inmunoterapia o fármaco en investigación
    -Diagnóstico de CPNM de predominio no epidermoide, confirmado mediante histología o citología
    -Existencia de al menos 1 lesión mensurable según los criterios de evaluación de la respuesta
    -Función hematológica adecuada
    Otros criterios de inclusión podrían aplicarse.
    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 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.
    -Cáncer de pulmón microcítico (CPM) o mixto (CPM y CPNM). Tumores epidermoides y carcinomas adenoepidermoides mixtos de predominio epidermoide
    - Cualquier toxicidad no resuelta desde la terapia sistémica previa
    - Presencia confirmada de mutaciones sensibilizantes del EGFR o de mutaciones por translocación EML4-ALK
    -Tratamiento previo con un inhibidor del factor de crecimiento del endotelio vascular (VEGF)
    -Hipersensibilidad conocida a cualquiera de los excipientes del PI y de la quimioterapia de combinación
    -Uso de medicación concomitante prohibida
    -Infección conocida por los virus de la hepatitis B, la hepatitis C o la inmunodeficiencia humana (VIH)
    -Varones fértiles o mujeres potencialmente fértiles que no utilicen los métodos anticonceptivos adecuados
    Otros criterios de exclusión podrían aplicarse
    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])
    TRG (según los criterios RECIST v 1.1) evaluada como la tasa de mejor respuesta (respuesta completa [RC] o respuesta parcial [RP])
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomisation to study treatment discontinuation
    Desde la aleatorización hasta la discontinuación del tratamiento
    E.5.2Secondary end point(s)
    • 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)
    -Supervivencia sin progresión (SSP), definida como el tiempo desde la aleatorización hasta la primera PE documentada o hasta el fallecimiento, lo que antes suceda
    -Supervivencia global (SG), definida como el tiempo desde la aleatorización hasta la muerte por cualquier causa
    -Duración de la respuesta (DDR), definida como el tiempo desde la primera RP o RC documentada (según RECIST v1.1) hasta la primera PE documentada o el fallecimiento, lo que antes suceda
    -Tasa de control de la enfermedad (TCE), definida como la tasa de RC, RP o enfermedad estable (EE) (>=6 semanas)
    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
    • DCR: the rate of CR, PR, Stable Disease (SD) (>=6 weeks)
    • Safety: from signature of informed consent, up to and including 30-day follow-up after last dose of study treatment
    • Immunogenicity: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first
    • PK: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first
    SSP: tiempo desde la aleatorización hasta la primera PE documentada o hasta el fallecimiento, lo que antes suceda
    SG: tiempo desde la aleatorización hasta la muerte por cualquier causa
    DDR: tiempo desde la primera RP o RC documentada (según RECIST v1.1) hasta la primera PE documentada o el fallecimiento, lo que antes suceda
    TCE: Tasa de control de la enfermedad (TCE), definida como la tasa de RC, RP o enfermedad estable (EE) (>=6 semanas)
    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 concerned10
    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 No
    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
    Bulgaria
    Canada
    Croatia
    France
    Georgia
    Germany
    Greece
    Hungary
    Italy
    Japan
    Korea, Republic of
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Data cut-off which occurs within a minimum of 12 months after randomisation of the last patient enrolled.
    El fin del estudio se define como la fecha límite de recopilación de datos, que tendrá lugar un mínimo de 12 meses después de la aleatorización del último paciente incluido.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 state50
    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.
    Tras el corte de datos, se cerrará base de datos y se abrirá el ciego.
    A los pacientes que reciban medicamento se les proporcionará la opción de continuar el tratamiento si el investigador cree que reciben beneficio. El promotor seguirá proporcionando medicamento tras el corte de datos mientras que ni AC ni perfil riesgo- beneficio ayuden a desarrollar FKB238, o las autoridades no hayan autorizado el fármaco. Se proporcionará fármaco hasta que la AC se obtenga y el reembolso esté disponible.
    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 Decision2016-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-26
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