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    Summary
    EudraCT Number:2009-011739-11
    Sponsor's Protocol Code Number:H3E-EW-S128
    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:2009-07-02
    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 number2009-011739-11
    A.3Full title of the trial
    Estudio fase 2 de Pemetrexed y Cisplatino como tratamiento de inducción, seguido de Pemetrexed y Cisplatino en combinación con radioterapia, en pacientes con cáncer de pulmón no microcítico, localmente avanzado, irresecable, estadio III de histología no escamosa

    Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin with Concurrent Thoracic Radiotherapy, in Patients with Unresectable Locally-Advanced Stage III, Non-Squamous, Non-Small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    A Study in Patients with Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberH3E-EW-S128
    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/ml milligram(s)/millilitre
    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/ml milligram(s)/millilitre
    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 Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namecisplatin
    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 INNcisplatin
    D.3.9.1CAS number 15663271
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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
    Cancer de Pulmon no Microcitico de Histologia 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 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer 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
    El objetivo principal de este estudio de fase 2 es evaluar la actividad antineoplásica del tratamiento de inducción con pemetrexed - cisplatino, seguido de la administración de pemetrexed – cisplatino con radioterapia torácica concomitante, en pacientes con CPNM no escamoso, irresecable, localmente avanzado (estadio III), en términos de supervivencia libre de progresión a 1 año, desde el inicio de la quimioterapia de inducción.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio evaluarán los siguientes puntos:
    • Tasa de respuestas tumorales objetivas.
    • Supervivencia global (SG).
    • Seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Diagnóstico histológico o citológico de CPNM no escamoso, irresecable, en estadio IIIA ó IIIB (sin presencia de derrame maligno pleural / pericárdico). No se permiten histologías no microcíticas de tipo escamoso y/o de células mixtas. Véase el anexo al protocolo S125.2; Criterios de estadificación para el cáncer de pulmón del American Joint Committee on Cancer; Greene y col., 2002.
    [2] Presentar una categoría funcional ECOG de 0 ó 1. Véase el anexo al protocolo S128.3 para obtener más detalles al respecto.
    [3] Se permite la radiación previa, pero ésta debe haberse administrado de forma limitada y no haber comprendido radiación en toda la pelvis, radiación torácica o radiación a > 25% de la médula ósea (Cristy y Eckermann 1987). Los pacientes deberán haberse recuperado de los efectos tóxicos de la radioterapia (con la excepción de la alopecia), previamente al reclutamiento en el estudio. La radioterapia previa debe haber finalizado 30 días antes de la inclusión en el estudio.
    [4] Presentar al menos una lesión medible en una dimensión, de acuerdo con los criterios RECIST, versión 1.0 (al menos 10 mm de diámetro longitudinal máximo, mediante tomografía computerizada helicoidal [TC], o al menos 20 mm, mediante técnicas habituales) (véase el anexo al protocolo S128.4; Therasse et al. 2000). Para medir las lesiones no deben utilizarse ni tomografías por emisión de positrones [PET] ni ecografías.
    [5] Esperanza de vida estimada de al menos 12 semanas.
    [6] Cumplimiento terapéutico del paciente y proximidad geográfica que permitan un seguimiento adecuado.
    [7] Función orgánica adecuada, incluidos los siguientes criterios:
    Reserva medular ósea adecuada: leucocitos >= 3,0 x 109/l, recuento absoluto de neutrófilos (ANC) >= 1,5 x 109/l, plaquetas >=100 x 109/l, y hemoglobina >=9 g/dl.
    Hepática: bilirrubina <=1,5 veces el límite superior de la normalidad (x LSN), fosfatasa alcalina (AP), aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) <=3,0 x LSN. . Los pacientes con transaminasas hepáticas entre 1 y 1.5 LSN no pueden mostrar indicación de metástasis hepáticas en un TAC de contraste.

    Renal: aclaramiento de creatinina (CrCl) calculado >=45 ml/min., basándose en la fórmula estándar de Cockcroft y Gault y (véase el anexo del protocolo S128.5) y creatinina sérica <=1,5 x LSN.
    Pulmonar: volumen espiratorio forzado en el primer segundo de expiración (FEV1) > 50% del volumen normal previsto, y una capacidad de difusión pulmonar para el monóxido de carbono (DLCO) > 40% del valor normal previsto.
    [8] Los pacientes deben firmar el documento de consentimiento informado.
    [9] Los pacientes deben tener al menos 18 años de edad.
    [10] Los pacientes deben haber completado un plan 3-D, y el médico responsable debe haber revisado y aprobado el histograma de dosis-volumen, debiendo ser el V20 pulmonar total <=35%.
    [11] En el caso de mujeres: Deben ser estériles por métodos quirúrgicos, ser posmenopáusicas o seguir una pauta anticonceptiva médicamente aprobada (p. ej., dispositivo intrauterino [DIU], anticonceptivos orales o dispositivo de barrera) durante el período de tratamiento y durante los 6 meses posteriores al mismo; deben presentar un resultado negativo en una prueba de embarazo en suero, realizada en el transcurso de los 7 días anteriores al reclutamiento, y no deben estar en período de lactancia.
    En el caso de varones: Deben ser estériles por métodos quirúrgicos o utilizar un método anticonceptivo durante el período de tratamiento y los 6 meses posteriores al mismo.
    [12] No haber recibido previamente un tratamiento antineoplásico sistémico para el CPNM. No se permite haber recibido quimioterapia adyuvante previamente.
    E.4Principal exclusion criteria
    [13] Haber recibido tratamiento en el transcurso de los últimos 30 días previos a la inclusión en el estudio, 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.
    [14] Haber completado o haber sido retirado anteriormente de este estudio, o de cualquier otro en el que se investigara pemetrexed.
    [15] Presentar un trastorno sistémico concomitante grave (por ejemplo, una infección activa, incluido el virus de la inmunodeficiencia humana) que, en opinión del investigador, podría comprometer su capacidad para cumplir el protocolo.
    [16] Tener una cardiopatía grave, como infarto de miocardio (en el transcurso de los seis meses previos), angina o cardiopatía, de clase III o IV, de acuerdo con los criterios de la New York Heart Association (véase el anexo al protocolo S128.6).
    [17] Presentar una neoplasia maligna previa, distinta de CPNM, carcinoma in situ de cuello uterino o cáncer de piel no melanomatoso, salvo que dicha neoplasia previa se haya diagnosticado y tratado definitivamente al menos 5 años antes, sin que exista ningún signo de recidiva. Los pacientes con antecedentes de cáncer de próstata localizado de bajo grado (puntuación de Gleason <= 6) se considerarán idóneos aunque el diagnóstico se haya efectuado en el transcurso de los 5 años previos.
    [18] Estar recibiendo simultáneamente cualquier otro tratamiento antineoplásico.
    [19] Haber perdido >10% del peso corporal en el transcurso de los 3 meses previos a la inclusión en el estudio.
    [20] Imposibilidad para interrumpir la administración de aspirina u otros antiinflamatorios no esteroideos (AINES), salvo la aspirina en dosis <= 1,3 gramos al día, durante al menos los 2 días previos (ó 5 días en el caso de fármacos de acción prolongada, [como piroxicam]), el día de la administración de pemetrexed y al menos durante los 2 días posteriores a su administración.
    [21] No poder o no estar dispuesto a tomar suplementos de ácido fólico o vitamina B12.
    [22]No tolerar o no estar dispuesto a tomar corticosteroides.
    [23]Haber recibido recientemente (en el transcurso de los 30 días previos a la inclusión) o estar recibiendo de manera concomitante una vacuna contra la fiebre amarilla.
    [24]Presentar hipersensibilidad conocida a pemetrexed, cisplatino, o a cualquiera de los excipientes de estos dos productos medicinales.
    [25]Presentar indicios clínicos de pérdida de audición.
    [26]Presentar una acumulación de líquidos en el tercer espacio clínicamente significativa (mediante exploración física), como ascitis o derrame pleural, que no pueda controlarse mediante drenaje u otro procedimiento antes de la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresion a un año
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 months6
    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 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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    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 Decision2009-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-23
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