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    Clinical Trial Results:
    MIMEB - Molecular Imaging with erlotinib and bevacizumab. A Phase II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients with Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) treated with Erlotinib and Bevacizumab and to Associate Imaging Findings with Molecular Markers

    Summary
    EudraCT number
    		 2009-012607-26
    Trial protocol
    		 DE  
    Global end of trial date
    23 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2021
    First version publication date
    15 May 2021
    Other versions
    Summary report(s)
    		 Final_Report_MIMEB

    Trial information

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    Trial identification
    Sponsor protocol code
    MIMEB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01047059
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Jürgen Wolf, Lung Cancer Group Cologne, juergen.wolf@uk-koeln.de
    Scientific contact
    Matthias Scheffler, University of Cologne, matthias.scheffler@uk-koeln.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression (CR+PR+SD) after 6 weeks of therapy in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab. To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of PFS in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab.
    Protection of trial subjects
    All patients had trial insurance as demanded by the Arzneimittelgesetz (AMG).
    Background therapy
    		 n/a
    Evidence for comparator
    		 n/a
    Actual start date of recruitment
    18 Jan 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    25
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Monocentric recruitment in Cologne, Germany.

    Pre-assignment
    Screening details
    		 18.01.2010 - 23.11.2013 in Cologne.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 Erlotinib and Bevacizumab in St. IV NSCLC; early and late FLT-, FDG-PET and DCE-MRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administrated once per day.

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusions q3 weeks.

    Number of subjects in period 1
    		Treatment arm
    Started
    40
    Completed
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 15 15
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60 (30 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 24 24
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All pateints that were included into the study

    Subject analysis sets values
    		 Intention-to-treat
    Number of subjects
    40
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    25
        From 65-84 years
    15
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    60 (30 to 76)
    Gender categorical
    Units: Subjects
        Female
    16
        Male
    24

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 Erlotinib and Bevacizumab in St. IV NSCLC; early and late FLT-, FDG-PET and DCE-MRI

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All pateints that were included into the study

    Primary: Changes in SUV

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    End point title
    		 Changes in SUV
    End point description
    Percentaged changes (proposed reductions) in the SUVs of PET images after one week of therapy as compared with the baseline assessment were compared with the response outcome (i. e., PD vs non-PD) in the first restaging procedure after six weeks of com-bined therapy. The related changes were analyzed using a responder-operator-characteristics (ROC) curve and the corresponding area under the curve (AUC). The maximal Youden-indices found in these analyses were then taken as cut-off values for Kaplan Meier analyses regarding PFS. Further, we tested predefined cut-off values (20%, 30% reductions in PET activities) regarding their potential role in discriminating patients with benefit from therapy as seen in prolonged PFS.
    End point type
    Primary
    End point timeframe
    18.01.2010 - 23.11.2013
    End point values
    		 Treatment arm Intention-to-treat
    Number of subjects analysed
    40
    40
    Units: n/a
    number (not applicable)
        Response
    40
    40
    Statistical analysis title
    		 Sample size calculation
    Statistical analysis description
    Assumptions: (1) 20% responder, 40% progressers; thus 60% non-progressers (2) Primary variable is the ‘area under the ROC curve (AUC, )’ (3) Type-I-error 0.043; type-II-error 0.20 (4) True accuracy (AUC) is at least 0.70 (alternative hypothesis; some common diagnostic tests have an AUC greater than 0.70) The sample size in the following table was calculated using formulae (6.3) and (6.6) in [118]. Thus, assuming Sigma1 = 0.75, about 40 patients are needed to reject the null hypothesis.
    Comparison groups
    Treatment arm v Intention-to-treat
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Responser Operator Characteristics (ROC)
    Parameter type
    		 Youden-Index
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    18.01.2010 - 23.11.2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: AE analysis is provided in summary.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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