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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-003356-30
    Sponsor's Protocol Code Number:M18-007
    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:2014-10-20
    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 number2014-003356-30
    A.3Full title of the trial
    A 3-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo versus Carboplatin, Pemetrexed plus 1 or 2 Truncated Courses of Demcizumab in Subjects with Non-Squamous Non-Small Cell Lung Cancer
    Estudio de fase 2, aleatorizado, doble ciego y con 3 grupos de carboplatino, pemetrexed y placebo en comparación con carboplatino, pemetrexed y 1 o 2 tandas truncadas de demcizumab en sujetos con cáncer de pulmón no microcítico no epidermoide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of two different treatment plans of demcizumab or placebo in combination with standard chemotherapy in non-squamous non-small cell lung cancer
    Estudio de dos planes de tratamiento diferentes con demcizumab o placebo en combinación con quimioterapia estándar en cáncer de pulmón no microcítico no epidermoide.
    A.3.2Name or abbreviated title of the trial where available
    DENALI
    DENALI
    A.4.1Sponsor's protocol code numberM18-007
    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 SponsorOncoMed Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportOncoMed Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoMed Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointVP, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address800 Chesapeake Drive
    B.5.3.2Town/ cityRedwood City, CA
    B.5.3.3Post code94063
    B.5.3.4CountryUnited States
    B.5.4Telephone number34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 namedemcizumab
    D.3.2Product code OMP-21M18
    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 INNDemcizumab
    D.3.9.2Current sponsor codeOMP-21M18
    D.3.9.4EV Substance CodeSUB32400
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Non-Squamous Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico no epidermoide.
    E.1.1.1Medical condition in easily understood language
    Lung cancer of the non-squamous and non-small cell type that cannot come from the cells that line the inner airways of the lungs or be of the type with very small cancer cells
    Cáncer de pulmón no microcitico de células no epidermoides, que no proviene de las células que recubren las vías respiratorias internas de los pulmones ni es de células cancerosas muy pequeñas.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer 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 compare the efficacy of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    Comparar la eficacia entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    E.2.2Secondary objectives of the trial
    - To compare the safety of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the rate of immunogenicity of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To determine population pharmacokinetics of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    -Comparar la seguridad entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    -Comparar la tasa de inmunogenicidad entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    -Determinar la farmacocinética poblacional de demcizumab cuando se combina con carboplatino y pemetrexed en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent Form
    2. Histologically or cytologically confirmed Stage IV non-squamous non-small cell lung cancer
    3. Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived
    4. Age >= 21 years
    5. ECOG performance status of 0 or 1
    6. Disease that is measurable per RECIST v1.1
    7. Adequate organ and marrow function
    8. For women of childbearing potential, agreement to use two effective forms of contraception
    1. Documento de consentimiento informado firmado.
    2. Cáncer de pulmón no microcítico no epidermoide en estadio IV confirmado mediante histología o citología.
    3. Disponibilidad de tejido tumoral fijado en formol e incluido en parafina (FFIP), ya sea de archivo u obtenido recientemente mediante biopsia con aguja gruesa.
    4. Edad >= 21 años.
    5. Estado funcional del ECOG de 0 o 1.
    6. Enfermedad mensurable según los criterios RECIST v 1.1.
    7. Función orgánica y medular adecuada.
    8. En las mujeres en edad fértil, compromiso de utilización de dos métodos anticonceptivos eficaces.
    E.4Principal exclusion criteria
    1. Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
    2. NSCLC with known EGFR mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4-ALK)
    3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous non-small cell lung cancer
    4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
    5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
    6. Metastases involving the lumen of the gastrointestinal tract
    7. Malignancies other than non-squamous non-small cell lung cancer successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
    8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
    9. Significant intercurrent illness defined as an illness that may result in the subject´s death prior to their death from non-squamous non-small cell lung cancer and/or significantly limit their ability to comply with the requirements of this study
    10. Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
    11. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIAs) within 6 months of randomization
    12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study
    13. Blood pressure (BP) of >140/90 mmH
    14. History, signs or symptoms indicative of an increased cardiac risk, including, but not limited to BNP value of >100 pg/mL, left ventricular ejection fraction (LVEF) <50%, peak tricuspid velocity >3.0 m/s on Doppler echocardiogram, history of or current cardiac ischemia or congestive heart failure
    1. Tumores no microcíticos y microcíticos mixtos avanzados y confirmados mediante histología o citología o carcinomas adenoepidermoides mixtos.
    2. CPNM con mutación de EGFR o translocación que afecte al gen de la quinasa del linfoma anaplásico (ALK) (como EML4-ALK) conocidas.
    3. Tratamiento previo o en curso (con quimioterapia, anticuerpos, inhibidores de la tirosina quinasa, radioterapia, inmunoterapia, terapia hormonal o tratamiento en investigación) para el cáncer de pulmón no microcítico no epidermoide en estadio IV.
    4. Evidencias de invasión tumoral de vasos sanguíneos importantes, cavitación de una o más masas tumorales pulmonares o de fístula traqueoesofágica.
    5. Metástasis cerebrales, afectación leptomeníngea, trastorno convulsivo no controlado o enfermedad neurológica activa.
    6. Metástasis afectando al lumen del tracto gastrointestinal.
    7. Tumores malignos distintos del cáncer de pulmón no microcítico no epidermoide tratados con éxito en los 3 años previos a la aleatorización (excepto ciertos tipos de cáncer en estadio temprano).
    8. Antecedentes de una reacción alérgica significativa atribuida al tratamiento con anticuerpos monoclonales humanizados o humanos.
    9. Enfermedad intercurrente importante, definida como toda aquella enfermedad que pueda causar la muerte del sujeto antes de su fallecimiento por el cáncer de pulmón no microcítico no epidermoide o que limite significativamente su capacidad para cumplir los requisitos de este estudio.
    10. Hemoptisis reciente > 2,5 ml o hemorragia grave en otro foco, trastorno hemorrágico o coagulopatía confirmadas o anticoagulación terapéutica.
    11. Antecedentes de accidente cerebrovascular (ACV) o accidente isquémico transitorio (AIT) en los 6 meses previos a la aleatorización.
    12. Intervención de cirugía mayor, biopsia abierta o traumatismo importante en los 28 días previos a la aleatorización o previsión de la necesidad de una intervención de cirugía mayor durante el estudio.
    13. Presión arterial (PA) > 140/90 mm Hg.
    14. Antecedentes, signos o síntomas indicativos de un mayor riesgo cardíaco, entre otros, valor de BNP > 100 pg/ml, fracción de eyección del ventrículo izquierdo (FEVI) < 50 %, velocidad tricuspídea máxima > 3,0 m/s en un ecocardiograma Doppler y antecedentes o presencia de isquemia cardíaca o insuficiencia cardíaca congestiva.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the Investigator-assessed median progression-free survival as assessed by RECIST v1.1 in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non squamous non-small cell lung cancer
    Comparar la mediana de supervivencia sin progresión determinada por el investigador conforme a los criterios RECIST v1.1, entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At scheduled visits.
    En las visitas estipuladas.
    E.5.2Secondary end point(s)
    - To compare the Investigator-assessed RECIST v1.1 response rate in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the Investigator-assessed RECIST v1.1 clinical benefit rate (i.e., the rate of complete response + partial response + stable disease) in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the Investigator-assessed progression-free survival at 6 months in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the median survival in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the Independent-Review-Facility-assessed RECIST v1.1 response rate and progression-free survival based solely on radiographs in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To determine the half-life, volume of distribution and clearance of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the safety profile through adverse events, monitoring, physical examination, vital signs, and clinical laboratory testing as outlined in the Schedule of Assessments between Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    - To compare the incidence of anti-demcizumab antibody development and neutralizing antibody development in subjects with 1st-line stage IV non-squamous non-small cell lung cancer in Arm 1 to Arm 2 and Arm 1 to Arm 3
    - Comparar la tasa de respuestas RECIST v1.1 evaluada por el investigador entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar la tasa de efectos clínicos beneficiosos RECIST v1.1 evaluada por el investigador (es decir, tasa de respuestas completas + respuestas parciales + enfermedad estable) entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar la supervivencia sin progresión evaluada por el investigador a los 6 meses entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar la mediana de supervivencia entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar la tasa de respuestas RECIST v1.1 evaluada por el centro de revisión independiente y la supervivencia sin progresión basándose exclusivamente en las radiografías entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Determinar la semivida, el volumen de distribución y el aclaramiento de demcizumab cuando se combina con carboplatino y pemetrexed en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar el perfil de seguridad mediante vigilancia de acontecimientos adversos, monitorización, exploración física, constantes vitales y análisis clínicos según se describe en el calendario de evaluaciones entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetoscon cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    - Comparar la incidencia de desarrollo de anticuerpos antidemcizumab y de anticuerpos neutralizantes entre los grupos 1 y 2 y entre los grupos 1 y 3 en sujetos con cáncer de pulmón no microcítico no epidermoide en estadio IV en el contexto de primera línea de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At scheduled visits.
    En las visitas estipuladas.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Italy
    New Zealand
    Spain
    United Kingdom
    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
    LVLS
    Ultima visita del último paciente.
    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 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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 201
    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)
    The patients will revert to the expected normal treatment of the condition
    Los pacientes recibirán el tratamiento médico habitual para su enfermedad.
    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 Decision2014-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-04
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