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    Summary
    EudraCT Number:2011-003719-42
    Sponsor's Protocol Code Number:GO27821
    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:2012-03-29
    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 number2011-003719-42
    A.3Full title of the trial
    A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND,
    PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND
    SAFETY OF MetMAb IN COMBINATION WITH EITHER BEVACIZUMAB
    + PLATINUM + PACLITAXEL OR PEMETREXED + PLATINUM AS
    FIRST-LINE TREATMENT IN PATIENTS WITH STAGE IIIB or IV
    NON-SQUAMOUS NON?SMALL CELL LUNG CANCER (NSCLC)
    ESTUDIO EN FASE II, ALEATORIZADO, MULTICÉNTRICO, DOBLE
    CIEGO CONTROLADO CON PLACEBO PARA EVALUAR LA
    EFICACIA Y LA SEGURIDAD DE MetMAb EN COMBINACIÓN CON
    BEVACIZUMAB + PLATINO + PACLITAXEL O CON PEMETREXED +
    PLATINO COMO TRATAMIENTO DE PRIMERA LÍNEA EN
    PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM)
    NO EPIDERMOIDE EN ESTADIO IIIB O IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and the safety of MetMAb in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum in lung cancer patients (non-squamous non-small cell lung cancer).
    ESTUDIO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MetMAb EN COMBINACIÓN CON BEVACIZUMAB + PLATINO + PACLITAXEL O CON PEMETREXED + PLATINO COMO EN
    PACIENTES CON CÁNCER DE PULMÓN (CÁNCER DE PULMÓN NO MICROCÍTICO)
    A.4.1Sponsor's protocol code numberGO27821
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMetMAb
    D.3.2Product code Ro 549-0258/F01-01
    D.3.4Pharmaceutical form 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 INNOnartuzumab
    D.3.9.1CAS number 1133766-06-9
    D.3.9.2Current sponsor codeRO5490258/PRO143966
    D.3.9.3Other descriptive nameOne Armed anti-cMet, OA5D5, c-Met, Anti-Met
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MET DIAGNOSTIC?POSITIVE NON?SMALL CELL LUNG CANCER
    (NSCLC)
    Cáncer de pulmón no microcítico (NSCLC) diagnosticado Met-positivos
    E.1.1.1Medical condition in easily understood language
    Incurable lung cancer (NSCLC)
    Cáncer de pulmón (NSCLC) incurable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025048
    E.1.2Term Lung cancer non-small cell recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? To evaluate the efficacy of MetMAb compared with placebo by PFS in all patients and in the subgroup of patients with Met diagnostic?positive tumors in each of two combination treatment cohorts:
    Cohort 1: MetMAb + bevacizumab + platinum + paclitaxel vs. placebo + bevacizumab + platinum + paclitaxel
    Cohort 2: MetMAb + platinum + pemetrexed vs. placebo + platinum + pemetrexed
    Evaluar la eficacia por PFS de MetMAb en comparación con placebo en todos los pacientes y en el subgrupo de pacientes con tumores diagnosticados met positivosen cada una de dos cohortes de tratamiento:
    Cohorte 1: MetMAb + bevacizumab + platino + paclitaxel en
    comparación con placebo + bevacizumab + platino + paclitaxel
    Cohorte 2: MetMAb + platino + pemetrexed en comparación
    con placebo + platino + pemetrexed
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy of MetMAb compared with placebo, as measured by OS, in each treatment cohort, in all patients and in those who have Met diagnostic?positive NSCLC
    ? To evaluate the efficacy of MetMAb compared with placebo, as measured by overall response rate (ORR), duration of response (DOR), and disease control rate (DCR), in each treatment cohort, in all patients and in those who have Met diagnostic?positive NSCLC
    ? To evaluate the safety and tolerability of MetMAb compared with placebo
    ? To describe the pharmacokinetics (PK) of MetMAb given in combination with bevacizumab, platinum, and paclitaxel or pemetrexed
    ? To evaluate the possible effect of MetMAb on the PK of bevacizumab, platinum, paclitaxel, and pemetrexed
    ? To evaluate potential immune responses against MetMAb
    Evaluar la eficacia de MetMAb en comparación con placebo, según lo determinado por la SG, en cada una de las dos cohortes de tratamiento descritas anteriormente, en las poblaciones por IT y Met-positiva
    Evaluar la eficacia de MetMAb en comparación con placebo, según lo determinado por la tasa de respuestas globales (TRO), la duración de la respuesta (DR) y la tasa de control de la enfermedad (TCE), en cada una de las dos cohortes de tratamiento descritas anteriormente, en las poblaciones por IT y Met-positiva.
    Evaluar la seguridad y la tolerabilidad de MetMAb en comparación con placebo
    Describir la farmacocinética (FC) de MetMAb cuando se administra en combinación con bevacizumab, platino y paclitaxel o pemetrexed
    Evaluar el posible efecto de MetMAb sobre la farmacocinética de bevacizumab, platino, paclitaxel y pemetrexed
    Evaluar la potencial respuesta inmune frente a MetMAb
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Written informed consent
    ? Male or female, 18 years of age or older
    ? ECOG performance status of 0 or 1
    ? Stage IIIB or Stage IV NSCLC tumors of non-squamous histology (Stage IIIB eligible only if stage T4 disease not amenable to definitive surgery or radiation therapy)
    ? For patients who received prior adjuvant chemotherapy:
    a treatment free interval of at least 12 months since the last chemotherapy cycle
    ? Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
    ? Adequate hematologic, hepatic, and renal function
    ? Adequate contraception, during the treatment period and for at least 90 days after the last dose of study drug, if applicable.
    Consentimiento informado por escrito
    Varones o mujeres de 18 o más años de edad
    Estado funcional del ECOG de 0 o 1
    CPNM no epidermoide en estadio IIIB o IV confirmado por histología o citología (pacientes con CPNM en estadio IIIB podrán participar solo si presentan enfermedad en estadio T4 no susceptible de cirugía o radioterapia definitivas).
    Pacientes que hayan recibido anteriormente quimioterapia adyuvante
    Tejido suficiente para el análisis por IHQ central del receptor Met y análisis del EGFR si se desconoce el estado del EGFR
    Adecuada función hematológica, hepática y renal
    Adecuado método anticonceptivo, durante el
    período de tratamiento y durante al menos 90 días después de la última dosis de la medicación del estudio
    E.4Principal exclusion criteria
    ? Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
    ? Mixed NSCLC histology with squamous cell predominance
    ? Prior exposure to experimental treatment targeting either the HGF or Met pathway
    ? Tumors confirmed to have EGFR activating mutations suitable for anti-EGFR therapy
    ? Known central nervous system (CNS) disease, other than stable, treated brain metastasis
    ? History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years (except for in situ cancer or basal or squamous cell skin cancer)
    ? Serum calcium > ULN (corrected for low serum albumin concentrations)
    ? Uncontrolled diabetes (fasting serum glucose level > 200 mg/dL)
    ? Pregnancy or lactation
    ? Significant history of cardiovascular disease
    ? Serious active infection or other serious underlying medical conditions
    ? Known HIV positivity
    ? Any major surgery, major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or an anticipated need for major surgery during the study
    ? Known sensitivity to any component of cisplatin or carboplatin
    ? (Patients with contraindications to bevacizumab or pemetrexed may not be included in those treatment cohorts)
    Tratamiento sistémico previo para el CPNM no epidermoide en estadio IIIB o IV
    Signos histológicos de CPNM mixto con predominio del tipo epidermoide
    Exposición previa a tratamiento experimental dirigido a la vía de HGF o Met
    Pacientes con tumores con mutaciones activadoras de EGFR confirmadas que sean adecuados para tratamiento anti-EGFR
    Enfermedad conocida del sistema nervioso central (SNC) que no sea estable y metástasis cerebrales tratadas
    Antecedentes de otra neoplasia maligna en los 3 años anteriores, con un intervalo sin enfermedad de < 3 años Podrán participar los pacientes con antecedentes de cáncer in situ o cáncer de piel basocelular o espinocelular.
    Calcio sérico > LSN (corregido respecto a unas bajas concentraciones séricas
    de albúmina)
    Diabetes no controlada, demostrada por una glucemia en ayunas 200 mg/dl
    Embarazo o lactancia
    Antecedentes importantes de enfermedad cardiovascular
    Infección activa grave u otras enfermedades subyacentes graves
    Pacientes VIH-positivos
    Cualquier intervención de cirugía mayor, procedimiento quirúrgico importante, biopsia abierta, pleurodesis abierta o lesión traumática significativa en los 28 días previos al día 1 del ciclo 1, o necesidad prevista de cirugía mayor durante el estudio
    Hipersensibilidad conocida a cualquiera de los componentes de cisplatino o carboplatino
    E.5 End points
    E.5.1Primary end point(s)
    ? Progression-free survival (PFS)
    Supervivencia libre de progresión (SSP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be evaluated when 48 investigator-assessed PFS events in
    patients with Met diagnostic-positive tumors and 96 PFS events in the ITT population have occurred.
    El análisis de la eficacia se realizará cuando se hayan producido 48 episodios de SSP evaluados por el investigador en pacientes con tumores Met-positivos y 96 episodios de SSP en la población
    por IT.
    E.5.2Secondary end point(s)
    ? Overall survival (OS)
    ? Overall response rate (ORR)
    ? Duration of response (DOR)
    ? Disease control rate (DCR)
    ? Adverse events, including serious AEs
    ? Clinical laboratory results and vital signs
    ? Pharmacokinetics for all components of study treatments
    Supervivencia global (SG).
    Tasa de respuestas objetivas (TRO).
    Duración de la respuesta objetiva (DRO).
    Tasa de control de la enfermedad (TCE).
    Acontecimientos adversos, incluyendo los AE graves
    Resultados clínicos de laboratorio y signos vitales
    Farmacocinética de todos los pacientes de los tratamientos de estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up for survival will continue until all patients have either died, or are lost to follow-up, or the Sponsor decides to end the trial, whichever occurs first.
    El seguimiento de la supervivencia continuará hasta que todos los pacientes hayan fallecido o se hayan perdido para el seguimiento, o el promotor decida poner fin al ensayo, lo que ocurra antes.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, QoL, Serum levels and incidence of anti-therapeutic
    antibodies (ATAs) against MetMAb
    Tolerabilidad, Calidad de vida, nieveles séricos e incidencia de ATA contra MetMAb
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MetMAb EN COMBINACIÓN CON PACLITAXEL + CISPLATINO O CARBOPLATIN
    MetMAb IN COMBINATION WITH PACLITAXEL + CISPLATIN OR CARBOPLATIN
    E.8.2.4Number of treatment arms in the trial4
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Brazil
    Colombia
    France
    Germany
    Israel
    Italy
    Latvia
    Malaysia
    Mexico
    Philippines
    Portugal
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The efficacy analysis will occur when 48 investigator-assessed PFS events in patients with Met diagnostic-positive tumors and 96 PFS events in the ITT population have occurred. Follow-up for survival will continue until all patients have either died, or are lost to follow-up, or the Sponsor decides to end the trial, whichever occurs first. Depending on study outcome, patients may be allowed to continue treatment if they are deriving benefit, with continued safety follow-up.
    El análisis de la eficacia se realizará tras 48 episodios de SSP evaluados por investigador en pacientes con tumores Met-positivos y 96 episodios de SSP en la población por IT. El seguimiento continuará hasta que todos los pacientes hayan fallecido o se hayan perdido para el seguimiento, o el promotor decida poner fin al ensayo, lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months26
    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: 169
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 91
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 260
    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)
    Currently, Roche does not have any plans to provide MetMAb or
    other study interventions to patients after the conclusion of the study
    or any earlier withdrawal. Patients who complete or withdraw from the
    study will be moved to appropriate treatment for NSCLC as determined
    by their doctor. However Roche will evaluate the appropriateness
    of continuing to provide MetMAb to study patients after evaluating the
    primary efficacy outcome measure and safety data gathered in the
    study.
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-16
    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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