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    Summary
    EudraCT Number:2006-000899-32
    Sponsor's Protocol Code Number:EMD72000-031
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-000899-32
    A.3Full title of the trial
    Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-small
    cell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes or gemcitabine
    A.4.1Sponsor's protocol code numberEMD72000-031
    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 SponsorEMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameMatuzumab
    D.3.2Product code EMD72000
    D.3.4Pharmaceutical form Powder 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 INNMatuzumab
    D.3.9.3Other descriptive nameMab<EGF-R>rH
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 IIIB/IV non-small cell lung cancer and progressive disease on or after
    first-line treatment with a platinum analogue in combination with either taxanes or gemcitabine
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061873
    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 tumor response rate (as assessed by the Independent Review Committee [IRC]) of 2 different regimens of matuzumab in combination with pemetrexed in comparison to pemetrexed alone in subjects with Stage IIIB/IV non-small cell lung cancer (NSCLC).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the following:
    • Tumor response rate (as assessed by the Investigator)
    • Overall survival
    • Time to tumor progression
    • Duration of response
    • Safety and tolerability
    • Quality of life (QoL)

    Additional objectives of this study include evaluation of:
    • Human antihumanized antibody (HAHA)
    • Pharmacokinetics (PK) of matuzumab
    • Epidermal growth factor receptor (EGFR) mutation analysis and association of EGFR mutations with tumor response
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. First written informed consent provided prior to any prescreening procedure and second written informed consent provided prior to any screening procedure
    2. Male or female, ≥18years of age
    3. Histologically or cytologically confirmed diagnosis of NSCLC
    4. Demonstrated progressive disease on or after first-line chemotherapy for Stage IIIB/IV disease. The first-line therapy must consist of platinum-based regimens in
    combination with taxanes or gemcitabine. Stage IIIB patients must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural
    can be effectively drained prior to admission into the study.
    5. A chemotherapy-free interval of at least 3 weeks between the end of first-line chemotherapy and start of study treatment
    6. At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7.2.2
    7. Archived tissue or cytologic sample available for the determination of EGFR expression, and evidence of tumor EGFR (HER-1) expression in the most recent
    available sample
    8. ECOG performance status 0-1
    9. Life expectancy >12 weeks
    10. Adequate baseline organ functions, defined as follows:
    Serum creatinine ≤1.5 × upper limit of normal (ULN)
    In case of borderline values for serum creatinine, creatinine clearance must be ≥45 mL/min
    Total bilirubin <1.5 × ULN
    Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 × ULN (Subjects with liver metastases should have ALT/AST <5 × ULN.)
    Absolute neutrophil count ≥1500/mm3
    Platelet count ≥100,000/mm3
    Hemoglobin level ≥10 g/dL
    11. If procreative potential (male or female), willingness to use effective contraceptive methods for the duration of treatment and continuing for 2 months after the last dose. Subjects of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea ≥12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy).
    E.4Principal exclusion criteria
    1. Radiotherapy or major surgery within 30 days prior to the start of study treatment
    2. Prior treatment with an EGFR-directed therapy or with EGFR signal transduction inhibitors
    3. Prior treatment with pemetrexed
    4. Pregnant (confirmed by β-HCG) or lactating female
    5. Weight loss >10% within 12 weeks prior to the start of study treatment
    6. Documented or symptomatic brain metastases or leptomeningeal disease
    7. Myocardial infarction within 6 months prior to the start of study treatment, uncontrolled congestive heart failure, or any current New York Heart Association
    Grade III or IV cardiovascular disorder despite treatment
    8. Presence of a ≥Grade 2 preexisting skin disorder (except for alopecia)
    9. Previous diagnosis of autoimmune disease with significant organ involvement
    10. Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in
    situ carcinoma of the cervix
    11. Any significant disease that, in the Investigator’s opinion, should exclude the subject from the study
    12. History of significant neurologic or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
    13. History of drug abuse within 6 months prior to the start of study treatment
    14. Known conditions that require concurrent treatment with a nonpermitted drug (see Section 6.8.2 of the protocol)
    15. Presence of a contraindication to the study treatment(s) according to the current Investigator’s Brochure (IB) for matuzumab and the labeling for pemetrexed
    16. Known hypersensitivity to the study treatment or any of its components
    17. Participation in another clinical study within 30 days prior to the start of study treatment
    18. Legal incapacity or limited legal capacity
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response rate (as determined by the IRC). Tumor assessments will be done by CT or MRI scanning obtained at screening and every 6 weeks (or sooner if medically indicated). Response assessments will be conducted according to modified WHO criteria.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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) 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) 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 Yes
    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 Information not present in EudraCT
    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
    In order to collect sufficient survival data, end of trial will be defined as the time point 6 months after the last subject has undergone the “End- of- study visit”.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    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 2006-05-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 50
    F.4.2.2In the whole clinical trial 150
    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)
    Once the subject has ended participation in the trial, there are no restrictions for care or treatment that this clinical trial imposes. Further care and treatment options are at the discretion of the subject and their treating physician.
    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 Decision2006-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-05
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