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    Summary
    EudraCT Number:2013-003760-30
    Sponsor's Protocol Code Number:EMR63325-021
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-10
    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 ConcernedSlovakia - SIDC (Slovak)
    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)
    Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie III. fázy porovnávajúce tecemotide s placebom u subjektov s dokončenou súbežnou chemorádioterapiou pri neresekovateľnom III. štádiu nemalobunkového karcinómu pľúc (NSCLC)
    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
    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 number+49 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)
    E.1.1.1Medical condition in easily understood language
    unresectable stage III non-small cell lung cancer
    (NSCLC)
    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.
    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.
    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.
    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
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 5 years or date of death, whichever is first
    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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline up to 12 weeks after the last dose administration
    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 concerned4
    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.
    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 state16
    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.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-02
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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