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    Clinical Trial Results:
    Erlotinib treatment beyond progression in EGFR mutant or patients who have responded to EGFR TKI in stage IIIB/IV NSCLC

    Summary
    EudraCT number
    		 2013-002049-13
    Trial protocol
    		 FI  
    Global end of trial date
    31 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2021
    First version publication date
    16 Nov 2021
    Other versions
    Summary report(s)
    		 Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    843
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oulu Univeristy Hospital
    Sponsor organisation address
    Kajaanintie 50, Oulu, Finland, 90220
    Public contact
    Jussi Koivunen, Oulu University Hospital, 358 83153789, jussi.koivunen@ppshp.fi
    Scientific contact
    Jussi Koivunen, Oulu University Hospital, 358 83153789, jussi.koivunen@ppshp.fi
    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
    21 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study efficacy and safety of Erlotinib treatment beyound diasease progression in combination with chemotherapy compared to chemotherapy alone in stage IIIB/IV non-small cell lung cancer patients with EGFR activating mutations or who have responded EGFR TKIs-
    Protection of trial subjects
    The trial was approved by PPSHP ethics committee (55/2013, EudraCT 2013-002049-13) and national competent authority (77/2013) and was carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All patients provided written informed consent before any study-related procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    9
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 18 out of planned 80 subject were recruited for the study.

    Pre-assignment
    Screening details
    		 E

    Period 1
    Period 1 title
    Recruitement (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chemotherapy
    Arm description
    		 Chemoterapy treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Chemotherapy (multiple products)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    According to nationals guidelines

    Arm title
    		 Chemotherapy+Erlotinib
    Arm description
    		 Chemotherapy+Erlotinib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chemotherapy (multiple products)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    According to national guidelines

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    183320-12-9
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg x1 d5-18 Q3W for cycles 1-5 and thereafter daily 150mg x1

    Number of subjects in period 1
    		Chemotherapy Chemotherapy+Erlotinib
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Chemotherapy
    Reporting group description
    		 Chemoterapy treatment

    Reporting group title
    Chemotherapy+Erlotinib
    Reporting group description
    		 Chemotherapy+Erlotinib

    Reporting group values
    		 Chemotherapy Chemotherapy+Erlotinib Total
    Number of subjects
    		 9 9 18
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        median (full range (min-max))
    		 67 (49 to 73) 57 (37 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 7 4 11
        Male
    		 2 5 7
    ECOG
    Units: Subjects
        ECOG 0-1
    		 8 6 14
        ECOG 2
    		 1 3 4
    EGFR mutation
    Units: Subjects
        ex19del
    		 8 5 13
        L858R
    		 1 3 4
        other
    		 0 1 1
    Previous EGFR TKI response
    Units: Subjects
        CR
    		 0 0 0
        PR
    		 9 8 17
        SD
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Chemotherapy
    Reporting group description
    		 Chemoterapy treatment

    Reporting group title
    Chemotherapy+Erlotinib
    Reporting group description
    		 Chemotherapy+Erlotinib

    Primary: PFS (median)

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    End point title
    		 PFS (median)
    End point description
    End point type
    Primary
    End point timeframe
    Progression-free survival (median)
    End point values
    		 Chemotherapy Chemotherapy+Erlotinib
    Number of subjects analysed
    9
    9
    Units: months
        median (standard error)
    14.71 ( 9.37 )
    18.27 ( 0.43 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Chemotherapy v Chemotherapy+Erlotinib
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Logrank
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: OS (median)

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    End point title
    		 OS (median)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall survival (median)
    End point values
    		 Chemotherapy Chemotherapy+Erlotinib
    Number of subjects analysed
    9
    9
    Units: months
        median (standard error)
    8.28 ( 0.98 )
    9.66 ( 3.13 )
    No statistical analyses for this end point

    Secondary: ORR

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    End point title
    		 ORR
    End point description
    End point type
    Secondary
    End point timeframe
    ORR
    End point values
    		 Chemotherapy Chemotherapy+Erlotinib
    Number of subjects analysed
    9
    9
    Units: responses
        CR
    0
    0
        PR
    2
    1
        SD
    3
    5
        PD
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the date of IC to final visit (1-4motnhs after study treatment completion)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Chemotherapy
    Reporting group description
    		 -

    Reporting group title
    Chemotherapy+erlotinib
    Reporting group description
    		 -

    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: The study only collected serious adverse events
    Serious adverse events
    		 Chemotherapy Chemotherapy+erlotinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 9 (66.67%)
    5 / 9 (55.56%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Neutropenic fever
         subjects affected / exposed
    4 / 9 (44.44%)
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Chemotherapy Chemotherapy+erlotinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2016
    Increase the time of recruitement period to 31.12.2016

    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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