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    Summary
    EudraCT Number:2008-004330-24
    Sponsor's Protocol Code Number:H3E-MC-S104
    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:2009-01-20
    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 number2008-004330-24
    A.3Full title of the trial
    Estudio fase 2 de Pemetrexed, Cisplatino y Cetuximab, seguido de un tratamiento de mantenimiento con Pemetrexed y Cetuximab, en pacientes con cáncer de pulmón no microcítico, localmente avanzado o metastásico (estadios IIIB o IV), de histología predominantemente no escamosa

    A Phase 2 Study of Pemetrexed and Cisplatin plus Cetuximab followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) other than Predominantly Squamous Cell Histology
    A.3.2Name or abbreviated title of the trial where available
    S104
    A.4.1Sponsor's protocol code numberH3E-MC-S104
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 ALIMTA 100 mg polvo para concentrado para sol. para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPEMETREXED
    D.3.9.3Other descriptive namePEMETREXED
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 ALIMTA 500 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPEMETREXED
    D.3.9.3Other descriptive namePEMETREXED
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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: 3
    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 ERBITUX 5 mg/ml solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK KGAA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCETUXIMAB
    D.3.9.3Other descriptive nameCETUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Cáncer de pulmón no microcítico, localmente avanzado o metastásico (estadios IIIB o IV), de histología predominantemente no escamosa
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Estimar la tasa de respuesta objetiva (TRO), según los Criterios de Evaluación de la Respuesta de los Tumores Sólidos (RECIST; Therasse y col., 2000; anexo al protocolo S104.4).
    E.2.2Secondary objectives of the trial
    - Estimar la supervivencia libre de progresión (SLP).
    - Estimar la tasa de supervivencia al cabo de 1 año.
    - Determinar el perfil de seguridad y toxicidad del tratamiento del estudio.
    - Evaluar los biomarcadores relevantes en relación con pemetrexed y cetuximab.
    - Evaluar la correlación entre los biomarcadores y los resultados clínicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Los pacientes o los representantes legales han firmado el documento de consentimiento informado (ICD), para la investigación clínica y la investigación traslacional.
    [2] Presentar un diagnóstico histológico de CPNM en estadios IIIB (no susceptible de recibir tratamiento curativo) o IV, de tipo histológico que no sea predominantemente escamoso (de ahora en adelante, "CPNM no escamoso" (anexo al protocolo S104.6).
    [3] Disponer de tejido biológico para detectar la expresión del EGFR en el tejido tumoral;
    [4] No haber recibido previamente quimioterapia sistémica, inmunoterapia, terapia dirigida o tratamientos biológicos para el CPNM. Se permite la quimioterapia adyuvante previa se ha finalizado >= 1 año antes del reclutamiento.
    [5] Se permite la irradiación previa del tórax si ésta ha finalizado al menos 12 semanas antes de la inclusión en el estudio;
    [6] Se permite la radioterapia previa si ésta ha afectado a menos del 25% de la médula (no así la radioterapia previa en toda la pelvis). La radioterapia previa debe haberse completado al menos 2 semanas antes del día 1 del ciclo 1, y los pacientes deberán haberse recuperado de los efectos tóxicos agudos de dicha radioterapia, previamente al día 1 del ciclo 1;
    [7] Tener enfermedad medible, de acuerdo con los criterios RECIST. Las lesiones diana no deben seleccionarse de la zona irradiada (Therasse y col, 2000) (anexo al protocolo S104.4);
    [8] Varones o mujeres que tengan al menos 18 años;
    [9] Categoría funcional ECOG de 0 ó 1 (Oken y col., 1982) (anexo al protocolo S104.3).
    [10] Tener una función orgánica adecuada, de acuerdo con los siguientes parámetros:
    Reserva medular ósea adecuada: recuento de leucocitos >= 3 x 109/l, recuento absoluto de neutrófilos (segmentados y bandas) >= 1,5 x 109/l, recuento de plaquetas >=100 x 109/l, y hemoglobina >= 9,0 g/dl;
    Hepática: bilirrubina <= 1,5 x límite superior de la normalidad (LSN); fosfatasa alcalina, alanina transaminasa, y aspartato transaminasa <= 2,5 x LSN (<= 5 x LSN si existen metástasis hepáticas);
    Renal: creatinina x<=1,5 x LSN, y aclaramiento de creatinina calculado >=45ml/min, basándose en la fórmula de Cockcroft-Gault (Cockcroft y Gault, 1976);
    Dichas pruebas deberán realizarse dentro de los 7 días previos al día 1 del ciclo 1.
    [11] Varones: Deberán utilizar un método anticonceptivo fiable durante el estudio y los 6 meses posteriores a la última dosis del fármaco del estudio;
    [12] Mujeres:
    Las mujeres en edad fértil deberán presentar en el momento del reclutamiento un resultado negativo en una prueba de embarazo en suero u orina, que deberá haberse realizado dentro de los 7 días previos al día 1 del ciclo 1, y deberán utilizar un método anticonceptivo fiable durante el estudio y durante los 6 meses posteriores a la última dosis del fármaco del estudio;
    Mujeres que no estén en edad fértil, es decir, que se hayan sometido a esterilización quirúrgica (histerectomía, ligación de trompas u ooforectomía) o sean posmenopáusicas.
    Mujeres posmenopáusicas, es decir, mujeres de al menos 45 años de edad, con útero intacto, que no hayan tomado anticonceptivos hormonales u orales en los últimos 6 meses, y que no hayan tenido menstruaciones durante al menos 1 año, o en las que se haya observado entre 6 y 12 meses de amenorrea espontánea, con valores de la hormona estimulantes del folículo (FSH) > 40 mIU/ml;
    [13] Tener una esperanza de vida estimada de al menos 12 semanas;
    [14] Estar dispuesto a cumplir los procedimientos del estudio y/o de seguimiento.
    E.4Principal exclusion criteria
    [15]Metástasis sintomáticas en el sistema nervioso central (SNC);
    [16]Tener un trastorno sistémico concomitante (por ejemplo, tuberculosis o una infección activa, entre las que se incluye el virus de la inmunodeficiencia humana [VIH]) que, en opinión del investigador, podría comprometer su capacidad para cumplir el protocolo;
    [17]Tener una cardiopatía grave, como por ejemplo infarto de miocardio, angina o cardiopatía, de clase II, III o IV, según la clasificación de la New York Heart Association, en los seis meses previos al día 1 del ciclo 1;
    [18]Haber presentado otra neoplasia maligna activa (excepto basalioma o carcinoma escamoso superficial (piel), o carcinoma in situ de cérvix) en los 5 últimos años;
    [19]Antecedentes de trastornos neurológicos o psiquiátricos importantes, incluidos la demencia, epilepsia y trastorno bipolar;
    [20]Presentar neuropatía periférica de grado CTCAE 1 o superior;
    [21]Haber recibido tratamiento en los 30 días previos al día del ciclo 1 con un fármaco que no haya recibido la aprobación de las autoridades reguladoras para ninguna indicación en el momento de la inclusión en el estudio;
    [22]Haberse sometido a cirugía mayor en las 4 semanas previas a la inclusión en el estudio;
    [23]Haber recibido tratamiento previo con inhibidores de la transducción o con tratamientos dirigidos al EGFR;
    [24]Estar recibiendo de forma concomitante inmunoterapia sistémica o quimioterapia (para cualquier enfermedad, excepto cáncer);
    [25]Presentar reacciones alérgicas o de hipersensibilidad conocidas a cualquiera de los componentes del tratamiento del estudio;
    [26]Estar embarazada o en período de lactancia;
    [27]Incapacidad para interrumpir la administración de aspirina u otros antiinflamatorios no esteroideos (AINES) –excepto aspirina, en una dosis < 1,3 gramos al día–, durante un periodo de 5 días (ó de 8 días en el caso de fármacos de acción prolongada, como el piroxicam);
    [28]El paciente no puede o rehúsa tomar suplementos de ácido fólico, vitamina B12 o corticoesteroides.
    [29]Presencia de acumulaciones clínicamente significativas de líquido en tercer espacio (por ejemplo, ascitis o derrame pleural) que no pueden ser controladas con drenaje u otros procedimientos, previamente al día 1 del ciclo 1;
    [30]Drogradicción conocida;
    [31]Haber recibido recientemente (en los 30 días previos al reclutamiento) o de manera concurrente una vacuna contra la fiebre amarilla.
    [32]Ser personal del centro del estudio, directamente relacionado con el estudio, y/o familiares cercanos. Son familiares cercanos el cónyuge, los padres, los hijos y los hermanos, tanto biológicos como adoptados;
    [33]Ser empleado de Lilly;
    [34]Estar actualmente reclutado, o haber abandonado en los 30 días previos, un ensayo clínico en el que se administre un fármaco experimental en una indicación no recogida en la ficha técnica (excepto el fármaco o dispositivo utilizado en este estudio), o estar en la actualidad reclutado en otro tipo de investigación médica que se considere que no es médica o científicamente compatible con este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de este estudio es evaluar la actividad antineoplásica de la combinación de pemetrexed, cisplatino y cetuximab, determinada por la tasa de respuesta global (TRG), en pacientes con CPNM no escamoso en estadios IIIB o IV.
    El criterio principal de valoración es la tasa de respuesta global, que se basa en la mejor respuesta que el paciente haya mostrado a lo largo de todos los ciclos de tratamiento. Los investigadores determinarán la respuesta de cada ciclo de acuerdo con los criterios RECIST. La tasa de respuesta global vendrá determinada por la proporción de pacientes de la población PQ que cumple los requisitos del protocolo (PQ), que presente una respuesta confirmada de RP o RC. Se determinará la TRG para la población de pacientes PQ, mediante una aproximación normal, para muestras amplias, sin ajustar, para proporciones binomiales (aproximación z). La tasa de respuesta se comparará con los datos históricos de referencia (control) -administración de pemetrexed y cisplatino, sin cetuximab, a una población similar de paciente-.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    La fecha límite para la inclusión de datos en el análisis final se establecerá
    como la primera de las siguientes fechas: a) cuando el último paciente complete el
    seguimiento de la supervivencia al cabo de 1 año o b) cuando el último paciente fallezca o se pierda el contacto con él/ella.
    Si después de realizar el análisis final los pacientes continúan beneficiándose del
    tratamiento del estudio, se permitirá que sigan recibiendo el tratamiento del estudio.
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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 Decision2009-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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