Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-004777-10
    Sponsor's Protocol Code Number:107240
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-004777-10
    A.3Full title of the trial
    A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III)
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-NSC-001 (ADJ-Chemo)
    A.4.1Sponsor's protocol code number107240
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 namerecMAGE-A3 recombinant protein formulated in AS15 adjuvant
    D.3.2Product code recMAGE-A3 + AS15
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor coderecMAGE-A3
    D.3.9.3Other descriptive namerecMAGE-A3 recombinant protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) 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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with pathologically proven MAGE A3-positive Non-Small Cell Lung Cancer in stage IB, II or III.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the humoral and cellular immune response induced by recMAGE-A3+AS15 in patients with MAGE-A3-positive Non-Small Cell Lung Cancer (NSCLC).
    • To evaluate the safety of recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC.
    E.2.2Secondary objectives of the trial
    Not Applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent has been obtained before performance of any protocol-specific procedure.
    2. Patient is at least 18 years of age at the time when informed consent is signed.
    3. Pathologically proven stage IB, II or III NSCLC.
    4. The patient's tumor shows expression of MAGE-A3 antigen, detected by RT-PCR.
    5.The patient is free of any distant metastasis, as shown by standard procedures at the site.
    6.For patients to be included in Cohort 1, all of the following.
    6a. Resected stage IB, II or IIIA NSCLC.
    6b. The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center.
    6c. ECOG performance status = 0 or 1 at the time of screening.
    6d. The patient is due to receive adjuvant chemotherapy as permitted in this protocol.
    6e. The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III).
    6f. First administration of chemotherapy can be scheduled to take place within the time-window of 4–8 weeks after surgery.
    7.For patients to be included in Cohort 2, all of the following.
    7a. Resected stage IB, II or IIIA NSCLC.
    7b. The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center.
    7c. ECOG performance status = 0 or 1 at the time of screening.
    7d. The patient is due to receive, or is already receiving, adjuvant chemotherapy as permitted in this protocol.
    7e. The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III).
    7f. First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 2–4 weeks after the last administration of chemotherapy
    7g. The patient has received at least two cycles of standard chemotherapy before study treatment with recMAGE A3 ASCI is initiated, whereafter no further chemotherapy is planned.
    8. For patients to be included in Cohort 3, all of the following.
    8a. Resected stage IB, II or IIIA NSCLC.
    8b. The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center.
    8c. ECOG performance status = 0 or 1 or 2 at the time of screening.
    8d. The patient has not received, is not receiving, and is not due to receive, adjuvant chemotherapy.
    8e. The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III).
    8f. First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 4–8 weeks after surgery.
    9. For patients to be included in Cohort 4, all of the following.
    9a. Unresectable stage III NSCLC.
    9b. ECOG performance status = 0 or 1 or 2 at the time of screening.
    9c. The patient is due to receive, or is already receiving, chemo- and radiotherapy according to standard practice at the institution.
    9d. The patient has received at least two cycles of standard chemotherapy before the initiation of study treatment with recMAGE A3+AS15 ASCI, whereafter no further chemo-/radiotherapy is planned.
    9e. The patient has stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy.
    9f. Administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 2–6 weeks after the last administration of chemo-/radiotherapy.
    10. Laboratory criteria (all of the following must be fulfilled at the time when study treatment is commenced): adequate bone-marrow reserve, adequate renal function and adequate hepatic function.
    11. (For female patients): EITHER the patient is not of child-bearing potential (i.e., have a current tubal ligation, have had a hysterectomy or an ovarectomy, or have been post-menopausal), OR she is sexually abstinent OR all of the following:
    – A urine Beta-HCG pregnancy test gives a negative result.
    – The patient has used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days before first study treatment.
    – The patient agrees to continue such precautions for two months after completion of the course of study treatment.
    12. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
    2. The patient is pregnant or lactating.
    3. The patient has a history of anaphylaxis or severe allergic reaction.
    4. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    5. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
    6. The patient is known to be HIV-positive.
    7. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
    [Notes: 1. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted. 2. The use of corticosteroids as anti-emetic treatment is permitted.]
    8. The patient needs home oxygenation.
    9. The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
    10. The patient has a history of chronic alcohol consumption and/or drug abuse.
    E.5 End points
    E.5.1Primary end point(s)
    Imunogenicity:
    Immunogenicity will be judged primarily after the fourth dose of ASCI, on the basis of:
    • The anti-MAGE-A3 seroconversion.
    • The anti-protein D seroconversion.
    • The MAGE-A3 cellular (T-cell) response.
    Additionally, these antibody and cellular T-cell responses will be analyzed at the end of the study.

    Safety:
    The safety of the cancer immunotherapeutic recMAGE A3+AS15, combined or not with standard chemotherapy, will be judged on the basis of:
    • Occurrence of adverse events during the study, including abnormal hematological and biochemical laboratory values.
    • Occurrence of serious adverse events during the study.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration of the recMAGE-A3+AS15 ASCI and chemo(-radio)therapy combination
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The last study visit is scheduled for approximately 5 weeks after the last study treatment.
    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 months8
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days21
    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.1.3Elderly (>=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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 72
    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)
    A plan for treatment after the patient has ended the participation in the trial is not provided for the cancer immunotherapeutics in the adjuvant setting. The cancer immunotherapeutics is still under investigation in this Phase I/II study and there is still no scientific or clinical rational for prolonging the immunisation treatment.
    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 Decision2007-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-08
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 15:47:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA