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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   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:2010-019707-32
    Sponsor's Protocol Code Number:1199.82
    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:2011-06-13
    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 number2010-019707-32
    A.3Full title of the trial
    LUME-Lung 3: Ensayo clínico de Fase I/II para evaluar el tratamiento oral continuo con BIBF 1120 añadido a la terapia estándar de gemcitabina/cisplatino como tratamiento de primera línea en pacientes con carcinoma no microcítico de pulmón e histología de células escamosas.
    LUME-Lung 3. A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first line NSCLC patients with squamous cell histology.
    A.3.2Name or abbreviated title of the trial where available
    LUME-Lung 3
    A.4.1Sponsor's protocol code number1199.82
    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 SponsorBoehringer Ingelheim España, 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 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 nameN/A
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 656247-18-6
    D.3.9.2Current sponsor codeBIBF 1120
    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 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.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 656247-18-6
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoma avanzado no microcítico de pulmón (recurrente o en estadío IIIB/IV) con histología de células escamosas.
    Advanced Non Small Cell Lung Cancer (recurrent or stage IIIB/IV) with squamous cell histology.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10001183
    E.1.2Term Adenocarcinoma of lung 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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10001177
    E.1.2Term Adenocarcinoma of lung 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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10001184
    E.1.2Term Adenocarcinoma of lung 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
    Fase I: confirmar la seguridad y tolerancia de BIBF 1120 a una dosis de hasta 200 mg/dos veces al día añadido a un régimen estándar de cisplatino/gemcitabina como tratamiento de primera línea en pacientes con carcinoma no microcítico de pulmón e histología de células escamosas.
    Farmacocinética de BIBF 1120 y metabolitos clínicamente relevantes, gemcitabina y cisplatino.
    Fase II: investigar la eficacia y seguridad de BIBF 1120 comparado con placebo como tratamiento de primera línea en pacientes con carcinoma no microcítico de pulmón e histología de células escamosas, y al menos enfermedad estable tras dos ciclos de quimioterapia con cisplatino/gemcitabina.
    Run-in Phase I: To confirm that up to a 200mg b.i.d dose of BIBF 1120, added to gemcitabine and cisplatin, is safe and tolerable added to a standard dose of cisplatin/gemcitabine in patients with stage IIIB/IV or recurrent non small cell lung cancer (NSCLC) with squamous cell histology. Pharmacokinetics of BIBF 1120 and clinically
    E.2.2Secondary objectives of the trial
    Fase I: Los objetivos secundarios para la etapa de Fase I son la evaluación de la respuesta objetiva y la mejor respuesta global, mediante estadísticas descriptivas. También se calcularán estadísticas descriptivas de las concentraciones plasmáticas por analito y unidad de tiempo, así como de diversos parámetros farmacocinéticos estándar.

    Fase II: Los objetivos secundarios para la etapa de Fase II incluyen el análisis de la respuesta objetiva, control de la enfermedad y supervivencia global. En los enfermos que consigan respuesta objetiva y control de la enfermedad, se evaluará también la duración de esta respuesta objetiva y la duración del control de la enfermedad, respectivamente.
    Además, se analizarán varios cuestionarios de Calidad de Vida Relacionada con la Salud (Health-Related Quality of Life) (HRQOL) los denominados cuestionarios QLQ-C30, QLQ-LC13 y EQ-5D.
    Run-in Phase I: The evaluation of objective response and best overall response by means of descriptive statistics. De
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Fase I:
    1. Diagnóstico confirmado por histología o citología de CPNM estadio IIIB/IV o recurrente con histología de células escamosas.
    2. Enfermedad medible según criterios RECIST 1.1.
    3. Puntuación de 0 ó 1en la escala de capacidad funcional del Eastern Cooperative Oncology Group (ECOG).
    4. Hombre o mujer con edad 18 años.
    5. Esperanza de vida de al menos tres (3) meses.
    6. Consentimiento informado por escrito de acuerdo con las directrices ICH-BPC.

    Fase II:
    7. Al menos Enfermedad Estable radiológicamente confirmada tras 2 ciclos pevios de quimioterapia con cisplatino/gemcitabina.
    Run-in Phase I
    1.Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent NSCLC with squamous cell histology.
    2.Measurable disease according to RECIST 1.1.
    3.Patient Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
    4.Male or female patients age ? 18 years.
    5.Life expectancy of at least three (3) months.
    6.Written informed consent in accordance with ICH-GCP guidelines.
    Phase II
    In addition to the above inclusion criteria:
    7.Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.
    E.4Principal exclusion criteria
    1. Tratamiento previo para CPNM avanzado, metastásico o recurrente. Se permite un tratamiento previo adyuvante, neoadyuvante o adyuvante + neoadyuvante si han pasado al menos 12 meses desde el final del tratamiento a la aleatorización.
    2. Tratamiento previo con otros inhibidores de VEGFR (distintos de bevacizumab).
    3. Enfermedad pulmonar intersticial preexistente conocida, p.ej., la originada por asbestosis.
    4. Pérdida de peso significativa (>10%) en las 6 semanas previas al inicio del tratamiento del estudio.
    5. Cualquiera de las contraindicaciones para el tratamiento con gemcitabina y/o cisplatino.
    6. Ototoxicidad y neuropatía sintomática > Grado 1 según criterios CTCAE.
    7. Uso de cualquier fármaco en fase de investigación en las 4 semanas previas a la entrada en el estudio 1199.82.
    8. Antecedentes de hemoptisis clínicamente significativa dentro de los 3 meses previos (más de una cucharadita de sangre expectorada al día).
    9. Anticoagulación con fines terapéuticos (excepto dosis bajas profilácticas de heparina y/o bolo de heparina según necesidades de mantenimiento de un dispositivo intravenoso) o tratamiento antiplaquetario (excepto tratamientos crónicos con dosis bajas 325mg al día de ácido acetilsalícilico).
    10. Antecedentes de episodio trombótico o hemorragia clínicamente significativa en los últimos 6 meses.
    11. Predisposición genética conocida a sangrado o trombosis.
    12. Enfermedades cardiovasculares significativas (p.ej. hipertensión no controlada con medicación, angina inestable, antecedentes de infarto de miocardio) en los últimos 6 meses, insuficiencia cardíaca congestiva > II según la clasificación de la NYHA, arritmia cardíaca clinicamente relevante, derrame pericárdico).
    13. Cirugía (excepto biopsia del tumor) en las 4 semanas previas a la aleatorización y cicatrización incompleta de la herida.
    14. Metástasis cerebrales activas (esto es, estables durante < 4 semanas, ausencia de tratamiento previo adecuado con radioterapia, sintomáticas, que requieran tratamiento con anticonvulsivantes; se permitirá el tratamiento con dexametasona si se se ha administrado a dosis estables durante al menos un mes antes de la inclusión del paciente en el estudio.)
    15. Enfermedad leptomeningea.
    16. Evidencia radiográfica de tumores cavitarios o necróticos.
    17. Tumores centralmente localizados con evidencia radiográfica (mediante TC o RMN) de invasión local de vasos sanguíneos importantes.
    18. Radioterapia (excepto de las extremidades) dentro de los 3 meses previos a las pruebas basales de imagen, y radioterapia por metástasis cerebrales < 4 semanas antes de las pruebas basales de imagen.
    19. Otras neoplasias malignas actuales o diagnosticadas en los últimos cinco (5) años (aparte de cáncer de piel no melanomatoso y de cáncer cervical in situ).
    20. Trastornos o alteraciones gastrointestinales que pudieran interferir con la absorción del fármaco del estudio.
    21. Cualquier otra enfermedad concomitante grave o disfunción orgánica que en opinión del investigador comprometería la seguridad del enfermo o podría interferir con la evaluación de la seguridad del fármaco del ensayo.
    22. Presencia de acúmulo de líquidos clínicamente significativos en tercer espacio (por ejemplo ascitis o derrames pleurales) que no puedan ser controlados con drenaje u otros procedimientos antes de la entrada en el estudio.
    23. Tiempo de protrombina y/o tiempo parcial de tromboplastina superiores al 50% respecto a los límites normales.
    24. Recuento absoluto de neutrófilos (RAN) < 1500 / mm3.
    25. Plaquetas < 100.000 / mm3.
    26. Hemoglobina < 9,0 g/dl.
    27. Alteración de la función renal demostrada por los siguientes parámetros (evaluados dentro de los 14 días desde la aleatorización): tasa de filtración glomerular (GFR) < 50 ml/min medido mediante el aclaramiento de creatinina con EDTA o la recogida de orina de 24 horas. Alternativamente, se puede utilizar la fórmula de Cockcroft y Gault (Apéndice 10.2) para estimar el GFR, pero si este GFR fuese < 50 ml/min, se deberá entonces medir por aclaramiento de creatinina con EDTA o recogida de orina de 24 horas.
    28. Bilirrubina total por encima del límite superior de la normalidad.
    29. ALT y/o AST > 2,5 veces el límite superior de la normalidad en presencia de metástasis hepáticas o ALT/AST > 1,5 veces el límite superior de la normalidad en pacientes sin metástasis hepáticas.
    30. Proteinuria de grado 2 CTCAE o superior.
    31. Pacientes con capacidad reproductora que sean sexualmente activas y no quieran utilizar un método anticonceptivo médicamente aceptable (p.ej., implantes, inyectables, anticonceptivos orales combinados, algunos dispositivos intrauterinos o pareja vasectomizada, o preservativos en el caso de los varones participantes) durante el estudio y al menos 6 meses después de la finalización del tratamiento activo.
    32. Embarazo o lactancia.
    33. Pacientes que no sean capaces de cumplir con el protocolo.
    34. Antecedentes de fístula abdominal, perfo
    E.5 End points
    E.5.1Primary end point(s)
    Fase I: Confirmar que una dosis de hasta 200 mg/dos veces al día de BIBF 1120, añadida a gemcitabina y cisplatino, es segura y tolerable en pacientes con cáncer de pulmón no microcítico en estadío IIIB/IV o recurrente con histología de células escamosas.

    Fase II: Explorar la Supervivencia Libre de Progresión de los pacientes tratados con BIBF 1120 añadido a cisplatino/gemcitabina frente a placebo añadido a gemcitabina y cisplatino.
    Run-in Phase I: To confirm that up to a 200mg b.i.d dose of BIBF 1120, added to gemcitabine and cisplatin, is safe and tolerable added to a standard dose of cisplatin/gemcitabine in patients with stage IIIB/IV or recurrent non small cell lung cancer (NSCLC) with squamous cell histology.

    Phase II: To explore the Progression Free Survival of patients treated with BIBF 1120 added to cisplatin/gemcitabine vs. placebo added to gemcitabine and cisplatin.
    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 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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Fase II doble-ciego controlado con placebo
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    NA
    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 months0
    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 months0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Mejor tratamiento de referencia disponible según el médico.
    Best standard care available as judged by the treating physician.
    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 Decision2011-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-17
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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
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