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    Summary
    EudraCT Number:2013-003760-30
    Sponsor's Protocol Code Number:EMR63325-021
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003760-30
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled phase III trial
    of tecemotide versus placebo in subjects with completed concurrent
    chemo-radiotherapy for unresectable stage III non-small cell lung cancer
    (NSCLC)
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo di fase III su tecemotide vs placebo in soggetti con carcinoma polmonare non a piccole cellule (NSCLC) di stadio III non resecabile che hanno completato la chemio-radioterapia concomitante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell
    Lung Cancer
    Tecemotide dopo chemio-radioterapia concomitante per carcinoma polmonare non a piccole cellule (NSCLC)
    A.4.1Sponsor's protocol code numberEMR63325-021
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number49 6151 72-5200
    B.5.6E-mailservice@merckgroup.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 nameL-BLP25
    D.3.2Product code EMD531444
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtecemotide
    D.3.9.1CAS number 420086-91-5
    D.3.9.2Current sponsor codeBLP25
    D.3.9.3Other descriptive nameBLP25 lipopeptide
    D.3.9.4EV Substance CodeSUB31480
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number403
    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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Endoxana Injection 1g
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Health Care Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEndoxana Injection 1g
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) 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 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 Yes
    D.3.11.13.1Other medicinal product typeThe low-dose once administration of the IMP is intended to inhibit the effector function of, or reduction in the number of regulatory T cells and their precursors.
    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 for suspension for injection
    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
    unresectable stage III non-small cell lung cancer
    (NSCLC)
    carcinoma polmonare non a piccole cellule (NSCLC) di stadio III non resecabile
    E.1.1.1Medical condition in easily understood language
    unresectable stage III non-small cell lung cancer
    (NSCLC)
    carcinoma polmonare non a piccole cellule (NSCLC) di stadio III non resecabile
    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 LLT
    E.1.2Classification code 10025052
    E.1.2Term Lung cancer non-small cell stage III
    E.1.2System Organ Class 100000004864
    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 overall survival (OS) time by treatment arm
    Confrontare il tempo di sopravvivenza complessiva (overall survival, OS) per braccio di trattamento.
    E.2.2Secondary objectives of the trial
    - Time to symptom progression (TTSP) as measured by the Lung Cancer
    Symptom Scale (LCSS).
    - Progression-free survival (PFS) time.
    - Time to progression (TTP).
    - Safety.
    - Tempo alla progressione dei sintomi (time to symptom progression, TTSP) come misurato mediante la Scala di valutazione della sintomatologia del carcinoma polmonare (Lung Cancer Symptom Scale, LCSS).
    - Tempo di sopravvivenza libera da progressione (progression-free survival, PFS).
    - Tempo alla progressione (time to progression, TTP).
    - Sicurezza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent, before any trial-related activities are
    carried out.
    2) Histologically or cytologically documented unresectable stage III
    NSCLC, including bronchioalveolar carcinomas. Cancer stage must be
    confirmed and documented by computed tomography (CT), magnetic
    resonance imaging (MRI) or positron emission tomography (PET) scan.
    3) Prior concurrent CRT which is defined as follows:
    - Minimum of 2 cycles of platinum-based chemotherapy.
    - Radiotherapy with total tumor dose ≥ 60 Gray (Gy) and a single
    fraction dose ≥ 1.8 Gy.
    - Overlap of radiotherapy with minimum 2 cycles of platinum-based
    chemotherapy (one cycle is defined as either 3 or 4 weeks depending on
    the
    chemotherapy regimen).
    4) Documented stable disease or objective response, according to
    Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary
    concurrent CRT for unresectable stage III disease, within 4 weeks (28
    days) prior to randomization
    5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    6) A platelet count, white blood cells (WBC) and hemoglobin value as
    defined in the protocol.
    7) Male or female,
    8) 18 years of age or over.
    Other protocol defined inclusion criteria could apply.
    - Consenso informato scritto, prima che venga avviata qualsiasi attività relativa allo studio.
    - NSCLC di stadio III non resecabile istologicamente o citologicamente documentato, compresi i carcinomi bronchioloalveolari. Lo stadio del tumore deve essere confermato e documentato da tomografia assiale computerizzata (TAC), risonanza magnetica (RMI) o scansione tomografica a emissione di positroni (PET).
    - CRT concomitante precedente è definita come segue:
    • Un minimo di 2 cicli di chemioterapia a base di platino.
    • Radioterapia con una dose tumorale totale ≥ 60 Gray (Gy) e una singola dose frazionata ≥ 1.8 Gy.
    • Sovrapposizione di radioterapia con minimo 2 cicli di chemioterapia a base di platino (un ciclo è definito come 3 o 4 settimane a seconda del regime chemioterapico).
    • Stabilizzazione della malattia o risposta obiettiva documentata, secondo i criteri di valutazione della risposta nei tumori solidi (Response Evaluation Criteria in Solid Tumors, RECIST) 1.1, dopo CRT concomitante primaria per malattia in stadio III non resecabile, entro le 4 settimane (28 giorni) precedenti alla randomizzazione.
    • Uno stato di validità ECOG pari a 0-1.
    • Una conta piastrinica, valori dei globuli bianchi ed emoglobina come definito da protocollo.
    • Maschi o femmine
    • ≥ di 18 anni di età.
    Altri criteri di inclusione definiti nel protocollo potrebbero applicarsi.
    E.4Principal exclusion criteria
    1) Undergone lung cancer specific therapy (including surgery) other
    than initial concurrent CRT.
    2) Received chemotherapy during radiotherapy in radiosensitizing doses
    only.
    3) Metastatic disease.
    4) Malignant pleural effusion at initial diagnosis, during initial CRT,
    and/or at trial entry.
    5) Past or current history of neoplasm other than lung carcinoma, except
    for curatively treated nonmelanoma skin cancer, in situ carcinoma of the
    cervix or other cancer curatively treated and with no evidence of disease
    for at least 5 years.
    6) A recognized immunodeficiency disease including human
    immunodeficiency virus (HIV) infection and other cellular
    immunodeficiencies, hypogammaglobulinemia or
    dysgammaglobulinemia; subjects who have hereditary, congenital or
    acquired immunodeficiencies.
    7) Splenectomy.
    8) Any preexisting medical condition requiring chronic systemic steroid
    or immunosuppressive therapy (steroids for the treatment of radiation
    pneumonitis are allowed).
    9) Receipt of immunotherapy (as defined in the protocol) within 4 weeks
    prior to randomization.
    10) Receipt of investigational systemic drugs (including off-label use of
    approved products) within 4 weeks (28 days) prior to randomization.
    11) Autoimmune disease.
    12) Active or chronic infectious hepatitis.
    13) Infectious process that, in the opinion of the investigator, could compromise the subject's ability to mount an immune response.
    14) Clinically significant hepatic dysfunction, renal dysfunction and
    cardiac disease as defined in the protocol.
    15) Clinically significant hepatic dysfunction, renal dysfunction and
    cardiac disease as defined in the protocol.
    16) Clinically significant cardiac disease, e.g., New York Heart
    Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled
    arrhythmia or
    uncontrolled hypertension, myocardial infarction in the previous 6
    months as confirmed by an ECG.
    17) Pregnant or breast-feeding women (for details see
    Inclusion Criteria).
    18) Known drug abuse/alcohol abuse.
    19) Participation in another interventional clinical trial within the past
    28 days (excluding purely observational studies).
    20) Requires concurrent treatment with a non-permitted drug.
    21) Known hypersensitivity to any of the trial treatment ingredients.
    22) Legal incapacity or limited legal capacity.
    23) Any other reason that, in the opinion of the investigator, precludes
    the subject from participating in the trial
    • Precedente terapia specifica per il carcinoma polmonare (chirurgia compresa) diversa dalla CRT concomitante iniziale.
    • Chemioterapia concomitante alla radioterapia ricevuta a dosaggi solamente radiosensibilizzanti
    • Malattia metastatica.
    • Effusione pleurica maligna alla diagnosi iniziale, durante la CRT iniziale e/o all’ingresso nello studio.
    • Anamnesi attuale o precedente di neoplasia diversa dal carcinoma polmonare, ad eccezione dei tumori cutanei non melanomatosi trattati terapeuticamente, del carcinoma in situ della cervice o di altro tumore trattato terapeuticamente e senza evidenza di malattia per almeno 5 anni.
    • Un’immunodeficienza accertata, comprese l’infezione da virus dell’immunodeficienza umana (HIV) e altre immunodeficienze cellulari, l’ipogammaglobulinemia o la disgammaglobulinemia; soggetti che presentano immunodeficienze ereditarie, congenite o acquisite.
    • Splenectomia.
    • Qualsiasi condizione medica preesistente che richieda una terapia steroidea cronica sistemica o immunosoppressiva (gli steroidi per il trattamento della polmonite da radiazione sono ammessi).
    • Immunoterapia (come definito da protocollo) nelle 4 settimane (28 giorni) precedenti alla randomizzazione.
    • Farmaci sperimentali sistemici (compreso l’uso off-label di prodotti approvati) ricevuti nelle 4 settimane (28 giorni) precedenti alla randomizzazione.
    • Malattia autoimmune.
    • Epatite infettiva attiva o cronica.
    • Processo infettivo che, a giudizio dello sperimentatore, potrebbe compromettere la capacità del soggetto di produrre una risposta immunitaria.
    • Disfunzione epatica clinicamente significativa, disfunzione renale clinicamente significativa e malattia cardiaca clinicamente significativa come da protocollo, ad es., classi III-IV della classificazione NYHA (New York Heart Association), angina incontrollata, aritmia incontrollata o ipertensione incontrollata, infarto miocardico nei 6 mesi precedenti come confermato da un ECG.
    • Donne in stato di gravidanza o allattamento (per dettagli, vedasi i Criteri di inclusione).
    • Abuso accertato di alcool/droghe.
    • Partecipazione a un altro studio clinico interventistico negli ultimi 28 giorni (esclusi gli studi puramente osservazionali).
    • Necessità di un trattamento concomitante con un farmaco non consentito.
    • Accertata ipersensibilità ad uno qualsiasi dei componenti del trattamento in studio.
    • Incapacità legale assoluta o relativa.
    • Qualsiasi altro motivo che, a giudizio dello sperimentatore, precluda la partecipazione del soggetto allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS) time. OS time will be measured from the date of
    randomization to the date of death or up to 5 years, whichever is first.
    tempo di sopravvivenza complessiva (overall survival, OS). L’OS sarà misurato dalla data di randomizzazione alla data del decesso o fino a 5 anni, a seconda di cosa si verifica prima
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 5 years or date of death, whichever is first
    dopo 5 anni o alla data di decesso, a seconda di cosa si verifica prima
    E.5.2Secondary end point(s)
    - TTSP as measured by the LCSS.
    - PFS time as determined by the investigator.
    - TTP as determined by the investigator.
    - Number of Subjects With Adverse Events (AEs), Serious AEs, treatment
    emergent AEs, AEs leading to death, and AEs with National Cancer
    Institute-Common Toxicity Criteria (NCI−CTC) toxicity Grade 3 or 4 and
    Injection site reactions (ISRs)
    - Number of subjects with clinically significant abnormal
    Electrocardiogram (ECG) and lab parameters
    • TTSP come misurato mediante LCSS
    • PFS come determinato dallo sperimentatore
    • TTP come determinato dallo sperimentatore
    • Numero di soggetti con eventi avversi (EA), eventi avversi gravi, eventi avversi emergenti dal trattamento, eventi avversi che portano alla morte, e AES di tossicità di grado 3 o 4 secondo criteri di tossicità comune del National Cancer Institute (NCI-CTC) e Reazioni nel sito di iniezione (ISR)
    • Numero di soggetti con elettrocardiogramma (ECG) anormale e parametri di laboratorio clinicamente significativi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline up to 12 weeks after the last dose administration
    al basale fino a 12 settimane dopo l'ultima dose somministrata
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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
    Austria
    Belarus
    Belgium
    Canada
    Chile
    Czech Republic
    Denmark
    France
    Germany
    Ireland
    Italy
    Kuwait
    Mexico
    Netherlands
    New Zealand
    Oman
    Poland
    Portugal
    Qatar
    Russian Federation
    Saudi Arabia
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    United Arab Emirates
    United Kingdom
    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
    Previous trial experience with tecemotide shows that subjects have
    remained on trial treatment for long periods of time. Therefore, the end
    of trial is defined as the date that the last eligible subject is transferred
    to an extension protocol or continues tecemotide treatment in another
    appropriate setting.
    Da precedenti studi con tecemotide è stato dimostrato che i soggetti sono
    rimasti in trattamento per lunghi periodi di tempo. Pertanto, la conclusione della sperimentazione viene definita come la data in cui l'ultimo soggetto elegibile viene trasferito ad un protocollo di estensione o continua il trattamento con tecemotide in un'altra modalità appropriata
    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 days0
    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 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: 637
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 365
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 321
    F.4.2.2In the whole clinical trial 1002
    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)
    After the end of this trial, all subjects will continue to receive medical
    care in accordance with the local standard of care by their health care
    provider depending on the subject's individual medical needs. Those
    subjects who received tecemotide will be offered to continue on
    treatment with tecemotide.
    Al termine di questo studio, tutti i soggetti continueranno a ricevere assistenza medica
    in conformità con lo standard locale di cura fornito per la loro assistenza sanitaria
    a seconda delle singole esigenze mediche del soggetto. Ai soggetti che hanno ricevuto tecemotide sarà offerto di continuare il trattamento con tecemotide.
    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 Decision2014-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-02
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