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    Summary
    EudraCT Number:2013-002609-78
    Sponsor's Protocol Code Number:ETOP4-12/CA184-310
    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:2014-02-26
    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 number2013-002609-78
    A.3Full title of the trial
    A randomised open-label phase II trial of consolidation ipilimumab in limited-stage SCLC after chemo-radiotherapy
    Estudio fase II, abierto, randomizado, de consolidación de ipilimumab tras quimiorradioterapia en pacientes con cáncer de pulmón de célula pequeña en estadio limitado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial comparing the standard treatment (chemotherapy and radiotherapy) alone with the standard treatment followed by ipilimumab in patients with lung cancer called ?small cell lung cancer (SCLC)? limited to the thorax and not spread into other tissues.
    Estudio que compara la quimioterapia estándar para el cáncer de pulmón microcítico con la misma quimioterapia añadiendo Ipilimumab en pacientes con enfermedad torácica limitada
    A.3.2Name or abbreviated title of the trial where available
    STIMULI: Small cell lung cancer Trial with IpiliMUmab in LImited disease
    A.4.1Sponsor's protocol code numberETOP4-12/CA184-310
    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 SponsorETOP (European Thoracic Oncology Platform)
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation, Brussels
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP
    B.5.2Functional name of contact pointETOP Coordinating Office
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4131389 93 91
    B.5.5Fax number+4131389 93 92
    B.5.6E-mailSTIMULI@etop-eu.org
    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 Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIpilimumab
    D.3.4Pharmaceutical form Concentrate for 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 INNIPILIMUMAB
    D.3.9.1CAS number 0477202-00-9
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    limited-stage SCLC
    Cáncer de pulmón microcítico en estadío limitado
    E.1.1.1Medical condition in easily understood language
    Lung cancer called ?small cell lung cancer (SCLC)? limited to the thorax and not spread into other tissues.
    Cáncer de pulmón llamado microcítico limitado en el tórax y no a otros tejidos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10041069
    E.1.2Term Small cell lung cancer limited stage
    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 evaluate whether patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by ipilimumab consolidation have a better overall survival compared to patients treated with chemo-radiotherapy and prophylactic cranial irradiation without ipilimumab consolidation.
    El objetivo principal es evaluar si los pacientes tratados con quimiorradioterapia e irradiación craneal profiláctica seguidas por consolidación con ipilimumab presentan una supervivencia global mejor que los pacientes tratados con quimiorradioterapia e irradiación craneal profiláctica sin consolidación con ipilimumab.
    E.2.2Secondary objectives of the trial
    - To evaluate secondary measures of clinical efficacy including progression free survival (PFS), objective response rate (ORR) and time to treatment failure.
    - To assess the safety and the tolerability of the treatment in both arms.
    - Evaluar la eficacia clínica incluyendo la supervivencia libre de progresión, tasa de respuesta objetiva y tiempo hasta el fallo del tratamiento
    - Estudiar la seguridad y la tolerabilidad del tratamiento en las dos ramas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For enrolment:
    - Histologically or cytologically confirmed small cell lung cancer
    - Untreated limited stage disease (LD) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for SCLC proposal). M0 proven by
    ? Whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals);
    OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan;
    ? brain MRI.
    within 28 days before start of cycle 1.
    - Age ? 18 years
    - ECOG performance status 0-1
    - Adequate haematological function:
    haemoglobin > 9 g/dL
    neutrophils count >1.5×109/L
    platelet count > 100 × 109/L
    - Adequate liver function:
    Total bilirubin < 2.5 × ULN
    ALT and/or AST < 2.5 × ULN
    alkaline phosphatase < 5 ULN
    - Adequate renal function: Calculated creatinine clearance ? 50 mL/min (Cockroft-Gault)
    - Pulmonary function FEV1 of 1.0L or > 40% predicted value and DLCO > 40% predicted value.
    - Patient capable of proper therapeutic compliance, and accessible for correct follow-up.
    - Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning treatment.
    - All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
    - Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment.
    - Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for
    a) Chemo-radiotherapy treatment and PCI, and subsequent randomisation
    b) Blood and tissue submission for translational research

    For randomization:
    - Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, ?85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI
    - non-PD after chemo-radiotherapy and PCI
    - ECOG performance status 0-2
    - Recovery of all adverse events to a grade ?1, except for fatigue, appetite, oesophagitis and renal impairment (where ?2 is allowed) and alopecia (any grade)
    - Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning consolidation treatment.
    Criterios de inclusión para el reclutamiento:
    ? Cáncer microcítico de pulmón confirmado histológica y/o citológicamente
    ? Enfermedad no tratada en estadio limitado, lo que se define como estadios I¬¬-IIIB según la séptima clasificación TNM (Propuesta de clasificación de la IASLC para el CMP). M0 demostrado por:
    o Estudio mediante PET-TAC con FDG corporal total, incluida TAC con contraste de tórax y abdomen superior (con hígado, riñones y suprarrenales);
    O BIEN estudio mediante TAC con contraste de tórax y abdomen superior (con hígado, riñones y suprarrenales) y rastreo óseo;
    o RM cerebral.
    en los 28 días anteriores al comienzo del ciclo 1
    ? Edad? 18 años
    ? Estado funcional del ECOG 0-1
    ? Funciones hematológica, renal, hepática y pulmonar adecuadas
    ? Función pulmonar: FEV1 de 1,0 L o >40% del valor predicho y DLCO >40% del valor predicho

    Criterios de inclusión para la randomización:
    ? Quimiorradioterapia completada según el protocolo: 4 ciclos de quimioterapia, 85% del PTV de la radioterapia torácica, y también ICP obligatoria completada
    ? No PE tras quimiorradioterapia e ICP
    E.4Principal exclusion criteria
    For enrolment:
    - Patient with mixed small-cell and non-small-cell histologic features
    - Patient with pleural or pericardial effusions proven to be malignant
    - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast.
    - Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient?s capacity to participate in the study.
    - Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy.
    - Known or suspected hypersensitivity to ipilimumab or any of its excipients.
    - Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results.
    - Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie steroids) treatment, such as but not limited to ulcerative colitis and Crohn´s disease, rheumathoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener?s granulomatosis).
    - Interstitial lung disease or pulmonary fibrosis
    - Women who are pregnant or in the period of lactation.
    - Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
    - Patients with any concurrent anticancer systemic therapy.
    - HIV, active Hepatitis B or Hepatitis C infection
    - Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer
    - Planned radiotherapy to lung of mean dose > 20 Gy or V20 > 35 %
    - Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study.
    - Prior chemotherapy or radiotherapy for SCLC

    For randomization:
    - Less than 4 cycles of chemotherapy administered, less than 85% PTV of thoracic radiotherapy delivered, or PCI not completed
    - Progressive disease after chemo-radiotherapy and PCI
    ? Paciente con características histológicas mixtas de tipo microcítico y no microcítico
    ? Paciente con derrame pleural o pericárdico de origen maligno demostrado
    ? Antecedentes documentados de trastorno severo de carácter autoinmunitario o enfermedad sintomática mediada por el sistema inmunitario que haya precisado tratamiento inmunosupresor (por ejemplo, corticosteroides) prolongado (más de 2 meses), como colitis ulcerosa y enfermedad de Crohn, artritis reumatoide, esclerosis sistémica progresiva (esclerodermia), lupus eritematoso sistémico o vasculitis autoinmunitaria (por ejemplo, granulomatosis de Wegener)
    ? Enfermedad pulmonar intersticial o fibrosis pulmonar
    ? Mujeres embarazadas o en periodo de lactancia
    ? Pacientes con cualquier tratamiento antitumoral sistémico concomitante
    ? Infección por VIH, hepatitis B o hepatitis C
    ? Pacientes que han tenido en los últimos 5 años o tienen en la actualidad un proceso maligno, EXCEPTO el carcinoma cutáneo basocelular o espinocelular, carcinoma in situ de cuello uterino o vejiga, o carcinoma de mama ductal in situ, adecuadamente tratados.
    ? Radioterapia torácica previa (antes de la inclusión)
    ? Dosis pulmonar media programada >20 Gy o V20 >35%
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from the date of randomisation until death from any cause.
    Tiempo desde la fecha de la randomización hasta el fallecimiento por cualquier causa
    E.5.2Secondary end point(s)
    - Progression-free survival by RECIST 1.1
    - Objective response determined by RECIST 1.1
    - Time to treatment failure
    - Adverse events graded according to CTCAE V4.0
    ? Supervivencia libre progresión, según RECIST 1.1
    ? Respuesta objetiva, según RECIST 1.1
    ? Tiempo hasta el fracaso del tratamiento
    ? Acontecimientos adversos, clasificados en grados según CTCAE v 4.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PFS: time from the date of randomisation until documented progression or death, if progression is not documented.
    - ORR: across all assessment time-points during the period from randomisation to termination of trial treatment. Objective response to chemo-radiotherapy determined by tumour assessment around week 15
    - Time to treatment failure: from the date of randomisation to discontinuation of treatment for any reason
    - AEs: during complete trial duration
    SLP: tiempo desde la randomización hasta la progresión documentada o muerte, si la progression no está documentada
    TRO: tasa de respuesta objetiva: a la quimioradioterapia determinada por la evaluación tumoral alrededor de la semana 15
    Tiempo hasta el fracaso del tratamiento: desde la fecha de randomización hasta la discontinuación del tratamiento por cualquier razón
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Observación
    Observation
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    France
    Germany
    Spain
    Poland
    Switzerland
    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
    Patient accrual is expected to be completed within 3 years. Patients will be followed until death ? thus follow-up estimated up to 3,5 years following the enrolment of the last patient. The trial will end with the preparation of the final report, scheduled for 7 years after the inclusion of first patient.
    El reclutamiento de los pacientes se espera que se complete en 3 años. Los pacientes se seguirán hasta el fallecimiento (seguimiento estimado de 3.5 años desde el reclutamiento hasta el último paciente incluido). El ensayo terminará con la preparación del informe final, programado para 7 años después de la inclusión del primer paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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 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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 247
    F.4.2.2In the whole clinical trial 260
    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 are followed until death at three month intervals during first 12 months after randomization and thereafter at six-month intervals (for a maximum of 3.5 years after last patient randomised).

    Trial treatment beyond disease progression will be permitted if patient meets the criteria outlined in the protocol.
    Los pacientes se seguirán hasta el fallecimiento en intervalos de 3 meses el primer año después de la randomización y posteriormente a intervalos de 6 meses durante un máximo de 3.5 años después que el último paciente se haya randomizado.

    Se permitirá el tratamiento de prueba más allá de progresión de la enfermedad si el paciente cumple los criterios establecidos en el protocolo.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Spanish Lung Cancer Group (SLCG)/ Grupo Español de Cancer de Pulmón (GECP)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-03
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