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    Summary
    EudraCT Number:2015-004026-34
    Sponsor's Protocol Code Number:SB8-G31-NSCLC
    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:2016-03-04
    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 number2015-004026-34
    A.3Full title of the trial
    A Phase III, Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin® in Subjects with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
    Estudio de Fase III, aleatorizado, en doble ciego y multicéntrico, para comparar la eficacia, la seguridad, la farmacocinética y la inmunogenia de SB8 (biosimilar a bevacizumab que se propone) frente a Avastin® en sujetos con cáncer no microcítico y no epidermoide de pulmón, metastásico o recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study Comparing SB8 to Avastin in Subjects with Lung Cancer (Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer)
    Estudio que compara SB8 con Avastin en sujetos con Cancer de Pulmón (cancer de pulmón no microcítico y no epidermoide, metastásico o recidivante)
    A.4.1Sponsor's protocol code numberSB8-G31-NSCLC
    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 SponsorSamsung Bioepis Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportSamsung Bioepis Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSamsung Bioepis Co., Ltd.
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address107, Cheomdan-daero, Yeonsu-gu
    B.5.3.2Town/ cityIncheon
    B.5.3.3Post code21987
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+34913913443
    B.5.5Fax number+82324556499
    B.5.6E-mailbioepisinfo@samsung.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 nameSB8, proposed bevacizumab biosimilar
    D.3.2Product code SB8
    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 codeSB8
    D.3.9.3Other descriptive nameSB8
    D.3.9.4EV Substance CodeSUB179936
    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.3.9.4EV 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
    The intended use of SB8 is the treatment of metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
    El uso previsto del SB8 es el tratamiento de cáncer no microcítico y no epidermoide de pulmón, metastásico o recidivante (NSCLC)
    E.1.1.1Medical condition in easily understood language
    The intended use of SB8 is the treatment of metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
    El uso previsto del SB8 es el tratamiento de cáncer no microcítico y no epidermoide de pulmón, metastásico o recidivante (NSCLC
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    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 equivalence of SB8 to Avastin®, in terms of the best overall response rate (ORR) by 24 weeks of chemotherapy in subjects with metastatic or recurrent non squamous NSCLC.
    Demostrar la equivalencia de SB8 y Avastin®, en cuanto a la tasa de respuesta global (TRG) a las 24 semanas de quimioterapia en sujetos con NSCLC no epidermoide, metastásico o recidivante.
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy of SB8 compared to Avastin® by
    - Progression free survival (PFS)
    - Overall survival (OS)
    - Duration of response (DOR)
    ? To evaluate the safety and tolerability of SB8 compared to Avastin®
    ? To evaluate the pharmacokinetics of SB8 compared to Avastin®
    ? To evaluate the immunogenicity of SB8 compared to Avastin®
    Evaluar la eficacia de SB8 en comparación con Avastin® mediante la:
    - Supervivencia sin progresión (SSP)
    - Supervivencia global (SG)
    - Duración de la respuesta (DR)
    Evaluar la seguridad y la tolerabilidad de SB8 en comparación con Avastin®
    Evaluar la farmacocinética de SB8 en comparación con Avastin®
    Evaluar la inmunogenia de SB8 en comparación con Avastin®
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Approximately 50% of the enrolled subjects will be participating by default in the PK sub-study for PK assessment and those subjects will be defined at the time of randomisation in the IWRS. PK assessments will be performed to provide supportive evidence to PK similarity.
    Aproximadamente el 50% de los sujetos reclutados participará por defecto en el subestudio PK para valoración PK y esos sujetos se definirán en el momento de la aleatorización en el sistema IWRS. Se harán evaluaciones de PK para aportar pruebas de apoyo a la similitud PK.
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for the study:
    1. Aged >= 18 years (if local regulations are different in this regard, follow the local regulations).
    2. ECOG performance status of 0-1 at Screening.
    3. Histologically and/or cytologically confirmed metastatic (TNM stage IV) or recurrent adenocarcinoma of the lung or large cell carcinoma of the lung or NSCLC-not otherwise specified (NOS).
    4. At least one measurable lesion according to RECIST v1.1.
    Para poder participar en el estudio, los sujetos deben cumplir todos los criterios siguientes:
    1. Edad >= 18 años (si las regulaciones locales difieren en este aspecto, seguir la regulación local)
    2. Estado funcional ECOG de 0-1 en la Selección.
    3. Adenocarcinoma pulmonar o carcinoma macrocelular de pulmón o NSCLC sin otra especificación (SOE), metastásico (estadio IV TNM) o recidivante, confirmado histológicamente y/o citológicamente.
    4. Al menos una lesión medible según los RECIST v1.1
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for the study:
    1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung (mixed tumour should be categorised according to predominant histology).
    2. Known activating mutations in EGFR gene or transforming rearrangements of ALK gene.
    3. Radiological or clinical evidence of tumour invasion into blood vessels or close to large vessels that may have risk of bleeding at the discretion of Investigator.
    4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
    5. Neoadjuvant or adjuvant chemotherapy for administered for NSCLC and completed less than 12 months prior to Randomisation.
    6. Previously treated with a monoclonal antibody and/or molecule targeting VEGFR-related and/or EGFR-related signalling pathways.
    7. Radiotherapy within 28 days prior to Randomisation (tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy are not considered as measurable lesion unless there has been demonstrated progression in the lesion.).
    Los sujetos que cumplan cualquiera de los criterios siguientes no son elegibles para el estudio:
    1. Diagnóstico de carcinoma microcítico de pulmón o de carcinoma epidermoide de pulmón (los tumores mixtos se clasificarán de acuerdo con la histología predominante).
    2. Mutaciones activadoras conocidas en el gen del EGFR o reordenamientos transformadores del gen de la ALK.
    3. Indicio radiológico o clínico de invasión tumoral en los vasos sanguíneos o cerca de los grandes vasos que, a criterio del investigador, pueda tener riesgo de hemorragia.
    4. Antecedentes de quimioterapia sistémica administrada en primera línea para NSCLC metastásico o recidivante.
    5. Quimioterapia neoadyuvante o adyuvante administrada para NSCLC y finalizada menos de 12 meses antes de la aleatorización.
    6. Tratamiento previo con un anticuerpo monoclonal y/o una molécula dirigida a las vías de señalización relacionadas con el VEGFR y/o relacionadas con el EGFR
    7. Radioterapia en los 28 días anteriores a la aleatorización (las lesiones tumorales situadas en una zona previamente irradiada o en una zona sometida a otra terapia locorregional, excepto para alivio del dolor, no se consideran lesiones medibles.).
    E.5 End points
    E.5.1Primary end point(s)
    The best ORR by 24 weeks of chemotherapy (best ORR is defined as the proportion of subjects whose best overall response is either complete response [CR] or partial response [PR] according to RECIST v1.1)
    TRG a las 24 semanas de quimioterapia (la TRG se define como la proporción de sujetos cuya mejor respuesta global es la respuesta completa [RC] o la respuesta parcial [RP] según los RECIST v1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour assessment will be performed after IP administration of Cycle 2, 4, and 6, and before planned Day 1 of Cycle 3, 5, and 7 and then will be performed every 4 cycles according to RECIST v1.1 and tumour size will be assessed by both Investigators and independent central reviewer.
    La evaluación del tumor se hará después de la administración del PEI de los Ciclos 2, 4 y 6, y antes del Día 1 planificado de los Ciclos 3, 5 y 7, y luego cada 4 ciclos, según los RECIST v1.1 y la valoración realizada por los investigadores y por un revisor central independiente. El análisis principal de la eficacia se basará en los datos de la revisión central independiente.
    E.5.2Secondary end point(s)
    - Progression free survival (PFS);
    - Overall survival (OS);
    - Duration of response (DOR)
    - Supervivencia sin progresión (SSP);
    - Supervivencia global (SG);
    - Duración de la respuesta (DR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Progression free survival (PFS), defined as the time from the date of Randomisation to the date of disease progression or death regardless of the cause of death. Subjects who are not progressed at the time of analysis will be censored at the date of EOT visit or the last tumour assessment date if the date of EOT is not available.
    - Overall survival (OS), defined as the time from the date of Randomisation to the date of death regardless of the cause of death. Subjects who are alive at the time of analysis will be censored at the date of last known alive.
    - Duration of response (DOR), defined as the time from documented tumour response (complete or partial) until documented disease progression. Only the subjects who achieve an initial tumour response will be evaluated for DOR.
    SSP, definida como el tiempo desde la fecha de la aleatorización hasta la fecha de progresión de la enfermedad o muerte independientemente de la causa de la muerte. Los sujetos que no presenten progresión en el momento del análisis se censurarán en la fecha de la visita de EOT.
    SG, definida como el tiempo desde la fecha de la aleatorización hasta la fecha de la muerte independientemente de la causa de la muerte. Los sujetos que estén vivos en el momento del análisis se censurarán en la última fecha en que se supo que estaban vivos.
    Duración de la respuesta (DR), definida como el tiempo desde la respuesta tumoral (completa o parcial) documentada hasta la progresión documentada de la enfermedad. Solo los sujetos que logren una respuesta tumoral inicial se evaluarán en cuanto a la DR.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenia
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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
    Belarus
    Georgia
    Germany
    Hungary
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Taiwan
    Ukraine
    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
    The date when deaths of all the randomised subjects have been observed, or 12 months from Randomisation of the last subject, whichever occurs first.
    Comunicación de la muerte de todos los sujetos aleatorizados, o 12 meses después de la aleatorización del último sujeto, lo que suceda antes.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 339
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 339
    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 state117
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 289
    F.4.2.2In the whole clinical trial 678
    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)
    None
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-09
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