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    Clinical Trial Results:
    Concomitant Tarceva® and irradiation in patients in local-regionally advanced non-small cell lung cancer. A phase II study

    Summary
    EudraCT number
    2008-008921-30
    Trial protocol
    DK  
    Global end of trial date
    04 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Nov 2021
    First version publication date
    05 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    09.02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløws vej 2, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital J. B. Winsløws vej 2, entrance 140, basement 5000 Odense C, +45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Olfred Hansen, Odense University Hospital J. B. Winsløws vej 2, entrance 140, basement 5000 Odense C, +45 2424 1588, Olfred.Hansen@rsyd.dk
    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
    31 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week) Primary endpoint - Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan
    Protection of trial subjects
    Patients were monitored closely and (pre-)medication for AEs was administered.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Jun 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    2
    From 65 to 84 years
    11
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with NCSLC stage IIB-IIIB without pleural fluid, who are candidates for curatively intended radiotherapy and concomitant Tarceva.

    Pre-assignment
    Screening details
    Patients with histologically or cytologically confirmed locally advanced NSCLC stage IIB-IIIB without pleural fluid. ECOG PS 0-2. ALAT ≤ 2 x ULN. Serum bilirubin ≤ 1.4 x ULN.

    Period 1
    Period 1 title
    Trial period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    TARLAL
    Arm description
    Radiotherapy with concomitant Tarceva.
    Arm type
    Experimental

    Investigational medicinal product name
    Tarceva
    Investigational medicinal product code
    Erlotinib
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tarceva 150 mg per day.

    Investigational medicinal product name
    Curatively intended radiotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    66 Gy (2 Gy x 33 F, 5 F per week).

    Number of subjects in period 1
    TARLAL
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trial period
    Reporting group description
    All patients

    Reporting group values
    Trial period Total
    Number of subjects
    15 15
    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)
    2 2
        From 65-84 years
    11 11
        85 years and over
    2 2
    Gender categorical
    Units: Subjects
        Female
    6 6
        Male
    9 9
    Subject analysis sets

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in trial.

    Subject analysis sets values
    Patients
    Number of subjects
    15
    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)
    2
        From 65-84 years
    11
        85 years and over
    2
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    9

    End points

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    End points reporting groups
    Reporting group title
    TARLAL
    Reporting group description
    Radiotherapy with concomitant Tarceva.

    Subject analysis set title
    Patients
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients in trial.

    Primary: Overall survival

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    End point title
    Overall survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    up to ten years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The trial ended due to insufficient patient inclusion. It does not make sense to perform a statistical analysis on 15 patients, when the trial was planned to include 57 patients.
    End point values
    TARLAL Patients
    Number of subjects analysed
    15
    15
    Units: months
        median (standard deviation)
    16.85 ± 18.99
    16.85 ± 18.99
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days after last treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Patients
    Reporting group description
    -

    Serious adverse events
    Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Dehydration
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonitis
         subjects affected / exposed
    6 / 15 (40.00%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fungal infection
    Additional description: in the mouth
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    Pneumonitis
         subjects affected / exposed
    6 / 15 (40.00%)
         occurrences all number
    6
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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.
    The trial ended because of insufficient patient inclusion.
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