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    Summary
    EudraCT Number:2014-004959-30
    Sponsor's Protocol Code Number:1373.3
    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:2015-10-05
    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 number2014-004959-30
    A.3Full title of the trial
    A randomised, double-blind phase II trial to determine efficacy, safety and immunogenicity of BI 1361849 (CV9202) maintenance vaccination therapy versus placebo given intradermally in patients with inoperable locally advanced NSCLC after definitive concurrent chemoradiation (CRT) therapy
    Estudio de fase II, aleatorizado y doble ciego, para determinar la eficacia, seguridad e inmunogenicidad del tratamiento vacunal de mantenimiento con BI 1361849 (CV9202) frente a placebo, administrado por vía intradérmica en pacientes con NSCLC localmente avanzado inoperable después de quimiorradioterapia concomitante definitiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to compare the anti-cancer vaccine BI 1361849 (CV9202) versus placebo in patients with non-small cell lung cancer after completion of chemoradiation therapy
    Ensayo clínico para comparar la vacuna antineoplásica BI 1361849 (CV9202) frente a placebo en pacientes con cáncer de pulmón no microcítico después de finalizar el tratamiento con quimiorradioterapia.
    A.3.2Name or abbreviated title of the trial where available
    Phase II study of BI 1361849 (CV9202) vs. placebo after definitive CRT
    Estudio de Fase II de BI 1361849 (CV9202) frente placebo después de quimiorradioterapia definitiva.
    A.4.1Sponsor's protocol code number1373.3
    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 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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+34 93 4045100
    B.5.5Fax number+34 93 4045580
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 1361849
    D.3.2Product code BI 1361849
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNno INN available
    D.3.9.2Current sponsor codeBI 1361849
    D.3.9.3Other descriptive nameBI 1361849 (CV9202), CV9202
    D.3.9.4EV Substance CodeSUB176625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non small cell lung cancer stage III after concurrent chemoradiation therapy
    cáncer de pulmón no microcítico (CPNM) después de quimiorradioterapia concomitante.
    E.1.1.1Medical condition in easily understood language
    Non small-cell lung cancer
    cáncer de pulmón no microcítico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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 explore whether BI 1361849 (CV9202) prolongs progression-free survival (PFS) in comparison to placebo (sham-vaccine).
    Explorar si BI 1361849 (CV9202) prolonga la supervivencia libre de progresión (PFS) en comparación con placebo (vacuna simuladora)
    E.2.2Secondary objectives of the trial
    - To determine whether BI 1361849 (CV9202) prolongs overall survival (OS).
    - To assess other efficacy criteria.
    - To analyse immunogenicity of BI 1361849 (CV9202).
    - To assess the safety and tolerability of BI 1361849 (CV9202).
    - Determinar si BI 1361849 (CV9202) prolonga la supervivencia libre de progresión (PFS).
    -Evaluar otros criterios de eficacia.
    -Analizar la inmunogenicidad de BI 1361849 (CV9202).
    -Evaluar la seguridad y tolerabilidad de BI 1361849 (CV9202).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histopathologically and/or cytologically confirmed inoperable, locally advanced non-small cell lung cancer (NSCLC) Stage IIIA or IIIB at diagnosis, absence of metastases confirmed by radiological evaluation including brain imaging (Computer tomography (CT) or Magnetic Resonance Imaging (MRI) and/or Positron emission tomography scan).

    - Previous concurrent chemoradiation therapy with the last chemotherapy dose administered >= 28 days and the last radiation dose received <= 84 days before randomisation.

    - Chemotherapy must have been platinum-based and consisted of 2 to 4 three-weekly or four-weekly cycles of doublet chemotherapy, and concurrent radiotherapy dose was 60 to 70 Gy in fractions of 1.8 - 2.0 Gy (daily biologically equivalent doses) and not conventional 2-dimensional therapy. Overlap of radiotherapy with a minimum of 2 cycles of the platinum-based chemotherapy is required. A deviation of up to 3 days from an exact overlap is acceptable.

    - Patient has radiologically assessed objective response (Complete Response, Partial Response) or at least stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as response to chemoradiation at the first post-chemoradiation imaging maintained at the last imaging prior to randomisation.

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    ? Diagnóstico de NSCLC en estadio IIIA o IIIB, localmente avanzado e inoperable, confirmado mediante estudios histopatológicos y/o citológicos, e inexistencia de metástasis confirmada mediante evaluación radiológica incluidas pruebas de imagen del cerebro (TAC, RM y/o PET).

    ? Quimiorradioterapia concomitante previa, de forma que la última dosis de la quimioterapia se haya administrado ? 28 días y la última dosis de la radiación ? 84 días antes de la aleatorización.

    ? La quimioterapia debe haberse basado en platino, administrándose entre 2 y 4 ciclos de doble quimioterapia antineoplásica cada tres o cada cuatro semanas, y la dosis de radioterapia concomitante debe haber variado entre 60 y 70 Gy en fracciones de 1,8 a 2,0 Gy (dosis equivalentes desde el punto de vista biológico) y no puede haber sido radioterapia bidimensional convencional. Es necesario que 2 ciclos de la quimioterapia basada en platino se hayan administrado simultáneamente con la radioterapia. Es aceptable una desviación máxima de 3 días en esta coincidencia temporal.

    ? El paciente tiene una respuesta objetiva evaluada radiológicamente (CR, PR), o como mínimo enfermedadestable (SD) según los criterios RECIST 1.1., a la quimiorradioterapia en la primera prueba de imagen realizada después de la quimiorradioterapia que se mantiene en la última prueba de imagen efectuada antes de la aleatorización.

    ? Estado funcional del ECOG de 0 o 1.
    E.4Principal exclusion criteria
    - Proton therapy was part of the prior chemoradiation therapy to treat NSCLC.

    - Malignant effusion at diagnosis or any other time prior to start of chemoradiation. Malignancy of effusion must be excluded by analysis of the fluid, e.g. for pleural effusion by samples taken at 2 separate paracentesis time points, being negative for exudate and for blood and malignant cells. If at screening effusion is too small to be amenable to paracentesis and in the view of the investigator is unlikely to reflect malignancy, the patient is eligible.

    - Distant metastasis. Absence of brain metastasis needs to be confirmed by imaging (CT, MRI) after chemoradiation therapy and prior to randomisation.

    - Any previous or ongoing systemic treatment of NSCLC before randomisation, other than completed concurrent chemoradiation therapy as defined in this protocol. Supportive or alternative / complementary treatment with no relevant effect on the immune system is permitted.

    - Major surgery (based on investigator's judgement) for NSCLC other than diagnostic or staging biopsies prior to randomisation.

    - Condition requiring chronic immunosuppressive treatment including systemic steroid doses of >= 10 mg prednisone equivalent per day.

    - Major inflammatory events including colitis, thyroiditis, or hepatitis within 28 days before randomisation.

    - Known pre-existing interstitial lung disease, including pneumonitis of Common Terminology Criteria for Adverse Events grade >1 at screening.

    - Known autoimmune disorder (incl. type I diabetes, rheumatoid arthritis, multiple autoimmune endocrine disorders) or immunodeficiency.
    ? Se administró protonterapia como parte de la quimiorradioterapia previa para el tratamiento del NSCLC.

    ? Derrame neoplásico en el momento del diagnóstico o en cualquier otro momento antes del inicio de la quimiorradioterapia. Debe descartarse la presencia de derrame neoplásico mediante un análisis del líquido, p. ej., para descartar la presencia de derrame pleural, deberán obtenerse muestras mediante paracentesis en 2 momentos distintos y el resultado debe ser negativo para exudado y para la presencia de glóbulos sanguíneos y células cancerosas. Si en el momento de la selección el derrame es tan pequeño que no puede constatarse mediante paracentesis, y en opinión del investigador la presencia de células cancerosas es improbable, el paciente será apto para participar en el estudio.

    ? Metástasis distantes. Debe confirmarse la inexistencia de metástasis cerebral mediante una prueba de imagen (TAC, RM) después de la quimiorradioterapia y antes de la aleatorización.

    ? Haber recibido o estar recibiendo un tratamiento sistémico para el NSCLC antes de la aleatorización, salvo la quimiorradioterapia concomitante completada definida en este protocolo. Se permite tratamiento de soporte o alternativo/ complementario sin ningún efecto relacionado en el sistema inmunitario.

    ? Cirugía mayor (según el criterio del investigador) para el NSCLC, sin contar las biopsias con fines diagnósticos o de estatificación del tumor que se efectúen antes de la aleatorización.

    ? Estado del paciente que requiera tratamiento inmunosupresor crónico, incluidas dosis de corticosteroides sistémicos equivalentes a ? 10 mg de prednisona al día.

    ? Acontecimientos graves de inflamación, como colitis, tiroiditis o hepatitis en los 28 días anteriores a la aleatorización.

    ? Enfermedad pulmonar intersticial preexistente confirmada, incluida neumonitis de grado > 1 según los CTCAE en la selección.

    ? Trastorno autoinmunitario confirmado (incluida diabetes de tipo 1, artritis reumatoide o trastornos endocrinos autoinmunitarios múltiples) o inmunodeficiencia.
    E.5 End points
    E.5.1Primary end point(s)
    1: Progression-free survival (PFS), defined as time (days) from the date of randomisation to the date of progression or to the date of death, whichever occurs first.
    Supervivencia libre de progresión (PFS), definida como tiempo (días) desde lafecha de aleatorización hasta la fecha de progresión o muerte, lo que suceda antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization
    52, 90 y 156 semanas después de la aleatorización del último paciente y seguimiento hasta 3,5 años después de la última aleatorización.
    E.5.2Secondary end point(s)
    1: PFS status at 52 weeks after randomisation.

    2: PFS2, defined as time (days) from randomisation to either death or disease progression by investigator assessment occurring after initiation of 1st subsequent systemic anti-cancer therapy.

    3: Immune response status.

    4: Symptomatic progression, defined as time (days) from randomisation to an increase of at least 10 points from baseline for one or more of cough (Q1, QLQ-LC13), dyspnoea (Q3-5, QLQ-LC13) or chest pain (Q10, QLQ-LC13) based on the EORTC QLQ-LC13.

    5: Discontinuation of study treatment by 24 weeks after randomisation either due to an adverse event not related to tumour or due to patient withdrawal from study treatment for drug associated reasons.

    6: Overall survival (OS), defined as time (days) from the date of randomisation to the date of death.
    1: estado de PFS a las 52 semanas después de la aleatorización.

    2:PFS2, definido como el tiempo (días) desde la aleatorización hasta la muerte o progresión de la enfermedad mediante evaluación del investigador que ocurra después del inicio del 1r tratamiento antineoplásico sistémico posterior.

    3. Estado de la respuesta inmunitaria.

    4. Progresión sintomática, definida como el tiempo transcurrido desde la aleatorización hasta un aumento de al menos 10 puntos respecto al periodo basal en una o más de las puntuaciones de tos, disnea o dolor torácico según el cuestionario QLQ-LC13 de la EORTC.

    5. Interrupción definitiva del tratamiento del estudio a las 24 semanas de la aleatorización, debido bien a un acontecimiento adverso (no relacionado con el tumor) o a la retirada del tratamiento del estudio en el paciente por motivos relacionados con el fármaco.

    6. Supervivencia global , definida como el tiempo (días) desde la fecha de aleatorización hasta la fecha de la muerte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 52 weeks after randomization

    2: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization

    3: 52 weeks after the last patient has been randomized

    4: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization

    5: 24 weeks after randomization

    6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization


    6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization

    6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization
    1: 52 semanas después de la aleatorización.

    2: 52, 90 y 156 semanas después de la aleatorización del último paciente y seguimiento hasta 3,5 años después de la última aleatorización.

    3: 52 semanas después de la aleatorización del último paciente.

    4:52 ,90 y 156 semanas después de la aleatorización del último paciente y seguimiento durante 3,5 años depués de la última aleatorización.

    5: 24 semanas después de la aleatorización.

    6: 52, 90 y 156 semanas después de la aleatorización del último paciente y seguimiento durante 3,5 años depués de la última aleatorización.
    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 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 No
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Taiwan
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 317
    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)
    Patients will receive second line treatment or best standard of care per choice of the treating physician.
    Los pacientes recibirán tratamiento de segunda línea o el mejor cuidado estándard según el médico.
    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 Decision2015-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-10
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