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    Summary
    EudraCT Number:2006-004945-40
    Sponsor's Protocol Code Number:GEN204
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-29
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-004945-40
    A.3Full title of the trial
    A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in Combination with Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
    A.3.2Name or abbreviated title of the trial where available
    Zalutumumab in Combination with Chemo-Radiation in NSCLC
    A.4.1Sponsor's protocol code numberGEN204
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 nameZalutumumab
    D.3.2Product code HuMax-EGFr
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZalutumumab
    D.3.9.1CAS number 667901-13-5
    D.3.9.2Current sponsor codeZalutumumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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
    Stage IIIA-IIIB Non Small Cell Lung Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that treatment with zalutumumab in combination with chemo-radiation is superior to chemo-radiation alone in terms of progression free survival in treatment naïve stage IIIA–IIIB NSCLC patients.
    E.2.2Secondary objectives of the trial
    To investigate zalutumumab in combination with radiotherapy and in combination with chemo-radiation therapy with respect to safety and efficacy, to evaluate if gene copy number has a value as prognostic factor as well as being a biomarker for response to zalutumumab, and to determine the pharmacokinetic profile of zalutumumab in stage IIIA-IIIB NSCLC patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological diagnosis of NSCLC in one of the following subtypes: Squamous cell carcinoma, basaloid carcinoma, adenocarcinoma, adenosquamous carcinoma, large cell carcinoma, large cell neuroendocrine carcinoma, giant cell carcinoma, sarcomatoid carcinoma and non small cell carcinoma NOS
    2. Any stage III NSCLC based on CT scan, due to invasion or involvement of mediastinal structures or lymph nodes. In the latter case, proof of nodal status involvement should be confirmed either by cytology or histology, or by appropriate PET imaging (for definition of nodal status, see section 20.2, Definition of Terms)
    3. Performance status 0 or 1 (Zubrod or WHO Scale)
    4. Age ≥ 18 years
    5. Following receipt of verbal and written information about the trial, the patient has provided signed informed consent before any trial related activity is carried out
    E.4Principal exclusion criteria
    1. Evidence of metastases (based on whole body PET scan and CT scan or MRI of brain), either in a separate lobe of the lung, or extra thoracic
    2. Malignant pleural effusion defined as any significant pleural effusion that has been proven cytologically positive. Non-malignant pleural effusions need to be negative on at least 2 punctures with cytological examination and/or thoracoscopy.
    3. Patients in whom the necessary radiation treatment volume would result in a high risk of radiation pneumonitis (defined subsequently as V20 > 35%).
    4. Estimated life expectancy of less than 3 months
    5. Unwillingness and inability to attend the required follow-up
    6. Bone marrow reserve: white blood cell count (WBC) < 3.0 x 10^9/L, neutrophils < 1.5 x 10^9/L, platelets < 100 x 10^9/L, hemoglobin < 10 g/dL
    7. Renal function: creatinine clearance calculated by the Cockcroft and Gault equation < 50
    8. Liver function: bilirubin > 1.5 x normal. ALT, alkaline phosphatase and AST > 2.5 x normal
    9. Impaired respiratory function as indicated by a forced expiratory volume in 1 second (FEV1) of less than, or equal to, 40% of predicted normal values OR a diffusion capacity for carbon monoxide (DLCO) of less than, or equal to, 50% of predicted normal values (based on measurement of both parameters)
    10. Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers
    11. History of interstitial pneumonitis
    12. Severe COPD requiring ≥ 3 hospitalizations over the past year
    13. Peripheral neuropathy > grade 1
    14. Unintended weight loss of ≥ 15% in the 3 months prior to enrolment
    15. Chronic or current infectious disease such as, but not limited to, chronic renal infection, sinusitis, tuberculosis, and chronic chest infection with bronchiectasis
    16. Severe ongoing infection requiring intravenous antibiotic or antifungal therapy
    17. Serious concomitant systemic disorder incompatible with the trial
    18. Known HIV positive
    19. Known hepatitis B or hepatitis C
    20. Prior chemotherapy for lung cancer
    21. Prior radiotherapy to the chest
    22. Prior surgery with curative intent for lung cancer
    23. Previous exposure to EGFr monoclonal antibodies and/or small molecule inhibitors of EGFr
    24. Use of any anti-cancer or investigational agent in the 4 weeks immediately prior to screening
    25. Current participation in any other interventional clinical trial
    26. Breast feeding women or women with a positive pregnancy test at Visit 1
    27. Male not willing to use adequate contraception during and for 12 months after last dose of zalutumumab or woman of childbearing potential not willing to use adequate contraception such as hormonal birth control or intrauterine device, during trial and 12 months after last dose of zalutumumab. For patients in the USA the use of a double barrier method is also considered adequate.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) defined as the time from randomization until disease progression (verified by imaging technique and according to RECIST) or death
    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 Yes
    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
    Evaluate gene copy number as prognostic factor and biomarker for response to zalutumumab
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Chemotherapy in combination with radiotherapy
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    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 months4
    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 months4
    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 Information not present in EudraCT
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 273
    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 Decision2008-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-09
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