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    Clinical Trial Results:
    AZD9291, an irreversible EGFR-TKI, in relapsed EGFR-mutated non-small cell lung cancer patients previously treated with an EGFR-TKI, coupled to extensive translational studies.

    Summary
    EudraCT number
    		 2015-000307-10
    Trial protocol
    		 NO   DK   FI   LT   SE  
    Global end of trial date
    15 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2025
    First version publication date
    20 Jul 2025
    Other versions
    Summary report(s)
    		 TREM publication

    Trial information

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    Trial identification
    Sponsor protocol code
    TREM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02504346
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oslo university hospital
    Sponsor organisation address
    Ullernchaussen 70, Oslo, Norway, 0379
    Public contact
    Clinical Trial Unit, Oslo university hospital, 47 99723094, ot.brustugun@gmail.com
    Scientific contact
    Clinical Trial Unit, Oslo university hospital, 47 32862464, ot.brustugun@gmail.com
    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
    10 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy evaluation of AZD9291
    Protection of trial subjects
    Regular follow up visits with safety registration and radiology assessment to ensure dose reduction and/or pause from study treatment if non-acceptable adverse events or to discover progression of disease.
    Background therapy
    		 -
    Evidence for comparator
    		 No comparator, single arm design
    Actual start date of recruitment
    15 Jul 2015
    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
    Norway: 65
    Country: Number of subjects enrolled
    Sweden: 45
    Country: Number of subjects enrolled
    Denmark: 50
    Country: Number of subjects enrolled
    Finland: 25
    Country: Number of subjects enrolled
    Lithuania: 14
    Worldwide total number of subjects
    199
    EEA total number of subjects
    199
    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)
    91
    From 65 to 84 years
    104
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period July 2015 to November 2017, participating countries Norway, Denmark, Sweden, Finland, Lithuania

    Pre-assignment
    Screening details
    		 Patients with advanced lung cancer and a documentet EGFR-mutation who had progressed on at least one previous EGFR-TKI could be enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm
    Arm description
    		 All patients received study treatment (single arm design)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Osimertinib
    Investigational medicinal product code
    AZD9291
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg orally one daily

    Arm title
    		 Treatment arm2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Osimertinib
    Investigational medicinal product code
    AZD9291
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg orally one daily

    Number of subjects in period 1
    		Treatment arm Treatment arm2
    Started
    198
    1
    Completed
    198
    1
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 All patients received study treatment (single arm design)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Osimertinib
    Investigational medicinal product code
    AZD9291
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg orally one daily

    Number of subjects in period 2
    		Treatment arm
    Started
    199
    Completed
    199

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 199 199
    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)
    		 91 91
        From 65-84 years
    		 104 104
        85 years and over
    		 4 4
    Gender categorical
    Units: Subjects
        Female
    		 139 139
        Male
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 All patients received study treatment (single arm design)

    Reporting group title
    Treatment arm2
    Reporting group description
    		 -
    Reporting group title
    Treatment arm
    Reporting group description
    		 All patients received study treatment (single arm design)

    Primary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    End point type
    Primary
    End point timeframe
    Primary analysis
    End point values
    		 Treatment arm Treatment arm2
    Number of subjects analysed
    191
    1
    Units: Number of patients with PR or CR
    191
    1
    Statistical analysis title
    		 ORR
    Statistical analysis description
    Ratio of patients with measurable disease achieving PR or CR
    Comparison groups
    Treatment arm v Treatment arm2
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Ratio, single group
    Point estimate
    48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41
         upper limit
    		 55
    Variability estimate
    Standard deviation
    Notes
    [1] - Single arm study, analysis of proportion of patients responding to treatment

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    July 2015 to March 2023
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Total study population
    Reporting group description
    		 -

    Serious adverse events
    		 Total study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 199 (1.51%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    58 / 58
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    83 / 83
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    196 / 199 (98.49%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    133 / 199 (66.83%)
         occurrences all number
    133
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    83 / 199 (41.71%)
         occurrences all number
    83
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    87 / 199 (43.72%)
         occurrences all number
    87
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    85 / 199 (42.71%)
         occurrences all number
    85
    Paronychia
         subjects affected / exposed
    83 / 199 (41.71%)
         occurrences all number
    83
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    89 / 199 (44.72%)
         occurrences all number
    89

    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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