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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2008-005013-21
    Sponsor's Protocol Code Number:EMR 62202-811
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-03-13
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2008-005013-21
    A.3Full title of the trial
    ERBITUX
    A.3.2Name or abbreviated title of the trial where available
    GFPC 08-03
    A.4.1Sponsor's protocol code numberEMR 62202-811
    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 SponsorInstitut de Cancérologie de la Loire
    B.1.3.4CountryFrance
    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 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 Yes
    D.2.1.1.1Trade name ERBITUX 5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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 nameCetuximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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 Yes
    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
    Locally advanced non small cell lung cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025053
    E.1.2Term Lung cancer non-small cell stage IIIA
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the feasibility in terms of toxicity of the association of cetuximab and concomitant radio-chemotherapy in each of both arms, in order to select the best arm of association.
    E.2.2Secondary objectives of the trial
    in each of both treatment arms, to evaluate :
    - the compliance to the association of cetuximab and concomitant radio-chemotherapy
    - the global tolerance profile of treatments. A particular attention will be payed to the collection of lung toxicity until EVA2.

    In each of both treatment arms, to evaluate :
    - Objective response rate (full response and partial response) and the lasting of response to treatments
    - survival without progression and global survival
    - correlation between the expression of EGFR and toxicity, response and survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Regarding the disease :
    - non-small cell lung cancer cytologically or histologically proven, favouring if possible the histological evidence (posterior study of the expression of the EGFR).
    - Stage III A-N2 unresectable or stage IIIB
    - Presence of at least one measurable target in one dimension (at least 10 mm in spiral tomodensitometry)
    - possibility to include all targets in one single irradiation field
    - The impossibility to carry out a study of the expression of the EGFR is not an exclusion criteria.

    Regarding the patient :
    - Age >=18 and <70.
    - Patient not formerly treated
    - PS 0 or 1 (Performans Status or ECOG)
    - Weight loss <= 10% of the total weight in the 3 months prior to inclusion
    - Adequate hematological function with :
    neutrophil polynuclears >= 1500/mm3, platelets >= 100 000/mm3
    - Adequate kidney function : creatinine clearance >= 60ml/mm
    - Adequate liver function with total bilirubine <= 1.5 N, ASAT, ALAT <= 2.5 N
    - Correct respiratory function with FEV1 >= 40% in theory and diffusion capacity >= 50% in theory and PaO2 >= 60 mm Hg
    - Signed and dated informed consent document for the participation to the study before any test specific to the study
    - Signed and dated informed consent document for the use of biologicals samples

    Regarding the treatment :
    - Radiotherapy must be possible at a 66 Gy with dosimetry showing V20 <= 35% and DMP <= 20 Gy
    E.4Principal exclusion criteria
    Regarding the disease :
    - Prior treatment for lung cancer except endoscopic disobstruction
    - operable cancer
    - small cell lung cancer, neuroendocrine cancer, bronchoalveolar cancer
    - metastatic lung cancer
    - Superior vena cava syndrome
    - Stage IIIB cancer with puncturable pleurisy (even if cytology is negative)
    - Stage IIIB cancer with neoplasia pericarditis
    - Impossibility to include all target in one single irradiation field

    Regarding the patient :
    - Prior thoracic irradiation
    - Other severe concomitant cardiac pathology, including congestive heart failure, unstable angina pectoris, arrythmia, or existence of a non balanced ischaemia myocardiopathy
    - pre-existing interstitial pulmonary pathology
    - Patient pre-treated by anti-EGFR and/or anti-VEGF therapeutics
    - Known allergy to murine proteins and known allergy to a treatment delivered in the study
    - non controlled infectious condition
    - HIV-positive patient
    - peripheric neuropathy grade >2 (NCI-CTCAE criteria)
    - neurological or psychiatric touble preventing from understanding the study
    - other organic defect likely to prevent inclusion in the trial
    - History or simultaneity of another cancer except basal-cell epithelioma or a treated cervix in-situ carcinoma, or any other cancer treated by surgery only for at least 5 years
    - pregnant or breast-feeding female patient. female patients of child-bearing age and all male patients must have an adequate contraception means during the trial and the following 3 months.
    - Impossible patient monitoring
    - patient deprived of freedom after an administrative or judiciary decision
    - Patients having taken part in a therapeutic trial of a new molecule (regardless of its interest : curative, prophylactic or diagnostic) in the previous 30 days, or taking part part in a running clinical trial.
    - Definitive contraindication to corticosteroids.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point:
    - Toxicity will be evaluated by the rate of patients having shown at least one non haematological event except nausea and vomit (TNHNV) grade >= 3 from randomisation to EVA2 (i.e. at the end of the concomitant treatment) according to the scale of the NCI-CTCAE (version 3.0)


    Secondary end points :
    - Compliance will be evaluated by :
    The intensity dose of the delievered concomitant chemotherapy compared to the theoritical intensity dose. Precise rules of doses diminution, temporary or final interruption of concomitant chemotherapy according to toxicities are defined in the protocol.
    - The intensity dose of delivered cetuximab during the concomitant radio-chemotherapy compared to the theoritical intensity dose. Precise rules of doses diminution, temporary or final interruption of concomitant cetuximab according to toxicities are defined in the protocol. Precise rules of temporary or final interruption of radiotherapy according to toxicities are defined in the protocol.
    - Global tolerance evaluated by the scale of the NCI-CTCAE (version 3.0)

    Tertiary end points:
    - Response : evaluated according to RECIST criteria
    - Survival without progression and global survival, calculated from the date of randomisation
    - Expression of EGFR : evaluated by CISH and IHC
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    End of the follow up of the last included patient
    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 months3
    E.8.9.1In the Member State concerned days
    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) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-13. Yes
    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 state78
    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 Decision2009-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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