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    Clinical Trial Results:
    ELUXA 2: An international, randomised, multi-centre, active controlled, open-label Phase III study evaluating the efficacy of BI 1482694 versus standard platinum doublet chemotherapy in patients with T790M mutation positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on one prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment

    Summary
    EudraCT number
    		 2015-005079-26
    Trial protocol
    		 ES   BE   AT  
    Global end of trial date
    11 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Nov 2018
    First version publication date
    10 Nov 2018
    Other versions
    Summary report(s)
    		 Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    1370.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co KG, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co KG, +1 8002430127, clintriage.rdg@boehringer-ingelheim.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
    11 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the efficacy and safety of BI 1482694 versus standard platinum doublet chemotherapy as a second line treatment for patients with locally advanced or metastatic NSCLC whose disease progressed on or after one prior 1st line EGFR-TKI therapy and whose tumours carry at least one EGFR activating mutation and a T790M mutation versus standard platinum doublet chemotherapy.
    Protection of trial subjects
    No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entering the trial. 199998 number entered in population of trial subjects is "Not applicable", the number is added to match the count in the participant flow which we get after adding the NA value "99999" for each treatment arm.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2016
    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
    Portugal: 199998
    Worldwide total number of subjects
    199998
    EEA total number of subjects
    199998
    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)
    199998
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    		 All subjects had to be screened for eligibility to participate in the trial. Subjects had to attend specialist sites which would then ensure that they (the subjects) met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label trial

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 1482694
    Arm description
    		 Subjects were to be orally administered BI 1482694 800 mg once daily as 2 x 400 mg tablets; dose reduction to 600 mg once daily and 400 mg once daily (if applicable) in the presence of drug-related adverse events
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 1482694
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were to be orally administered BI 1482694 800 mg once daily as 2 x 400 mg tablets; dose reduction to 600 mg once daily and 400 mg once daily (if applicable) in the presence of drug-related adverse events

    Arm title
    		 Platinum based doublet chemotherapy
    Arm description
    		 Subjects were to be administered intravenous infusion of Chemotherapy once every 3 weeks (21 days) course: - Cisplatin at 75mg / m2 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 or - Carboplatin at AUC 5 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 - Pemetrexed 500 mg / m2 on day 1 of 21 as maintenance treatment allowed per SmPC/PI
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to be administered Cisplatin (Solution for infusion) Vials with 200 ml of 0.5 mg/ml solution Up to 6 infusions, each separated by 3 weeks

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to be administered Carboplatin (Solution for infusion) Vials with 60 ml solution at 10 mg/ml Up to 6 infusions at AUC5, each separated by 3 weeks

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were to be administered Pemetrexed (500 mg powder for reconstitution for infusion) Vials with 500 mg ; after reconstitution each vial contains pemetrexed at 25 mg/ml; infusion at 500 mg/m2 each separated by 3 weeks

    Number of subjects in period 1
    		BI 1482694 Platinum based doublet chemotherapy
    Started
    99999
    99999
    Completed
    99999
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BI 1482694
    Reporting group description
    		 Subjects were to be orally administered BI 1482694 800 mg once daily as 2 x 400 mg tablets; dose reduction to 600 mg once daily and 400 mg once daily (if applicable) in the presence of drug-related adverse events

    Reporting group title
    Platinum based doublet chemotherapy
    Reporting group description
    		 Subjects were to be administered intravenous infusion of Chemotherapy once every 3 weeks (21 days) course: - Cisplatin at 75mg / m2 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 or - Carboplatin at AUC 5 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 - Pemetrexed 500 mg / m2 on day 1 of 21 as maintenance treatment allowed per SmPC/PI

    Reporting group values
    		 BI 1482694 Platinum based doublet chemotherapy Total
    Number of subjects
    		 99999 99999 199998
    Age categorical
    Units: Subjects
    Age continuous
    All treated patients, those with evidence of receiving one or more doses of either BI 1482694 or standard chemotherapy was to be used for reporting. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) -
    Gender categorical
    All treated patients, those with evidence of receiving one or more doses of either BI 1482694 or standard chemotherapy was to be used for reporting. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    Units: Subjects
        Female
    		 99999 99999 199998
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    BI 1482694
    Reporting group description
    		 Subjects were to be orally administered BI 1482694 800 mg once daily as 2 x 400 mg tablets; dose reduction to 600 mg once daily and 400 mg once daily (if applicable) in the presence of drug-related adverse events

    Reporting group title
    Platinum based doublet chemotherapy
    Reporting group description
    		 Subjects were to be administered intravenous infusion of Chemotherapy once every 3 weeks (21 days) course: - Cisplatin at 75mg / m2 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 or - Carboplatin at AUC 5 in combination with Pemetrexed 500 mg / m2 on day 1 of 21 - Pemetrexed 500 mg / m2 on day 1 of 21 as maintenance treatment allowed per SmPC/PI

    Primary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS) [1]
    End point description
    Progression-free survival (PFS) is defined as time from randomisation until disease progression or death from any cause, whichever occurs earlier.
    End point type
    Primary
    End point timeframe
    time from randomisation until disease progression or death
    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: No subjects entered in the trial hence results are not available.
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [2]
    99999 [3]
    Units: years
        median (full range (min-max))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [2] - ITT
    [3] - ITT
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival (OS) is defined as the time from randomisation until death from any cause. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    time from randomisation until death
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [4]
    99999 [5]
    Units: years
        median (full range (min-max))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [4] - ITT
    [5] - ITT
    No statistical analyses for this end point

    Secondary: Objective response (OR)

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    End point title
    		 Objective response (OR)
    End point description
    Objective response (OR) is defined as best overall response of complete response (CR) or partial response (PR) from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    time from randomisation until the earliest of disease progression, death or last evaluable tumour assessment
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [6]
    99999 [7]
    Units: percentage of participants
        number (not applicable)
    99999
    99999
    Notes
    [6] - ITT
    [7] - ITT
    No statistical analyses for this end point

    Secondary: Time to OR

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    End point title
    		 Time to OR
    End point description
    Time to OR is defined as the time from randomisation until first documented CR or PR. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    time from randomisation until first documented CR or PR.
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [8]
    99999 [9]
    Units: years
        median (full range (min-max))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [8] - ITT
    [9] - ITT
    No statistical analyses for this end point

    Secondary: Duration of OR (DOR)

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    End point title
    		 Duration of OR (DOR)
    End point description
    Duration of OR (DOR) is defined as the time from first documented CR or PR until the earliest of disease progression or death among patients with OR. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    time from first documented CR or PR until the earliest of disease progression or death
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [10]
    99999 [11]
    Units: years
        median (full range (min-max))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [10] - ITT
    [11] - ITT
    No statistical analyses for this end point

    Secondary: Disease control (DC)

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    End point title
    		 Disease control (DC)
    End point description
    Disease control (DC) is defined as best overall response of CR, PR or stable disease (SD) from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    from randomisation until the earliest of disease progression, death or last evaluable tumour assessment
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [12]
    99999 [13]
    Units: percentage of participants
        number (not applicable)
    99999
    99999
    Notes
    [12] - ITT
    [13] - ITT
    No statistical analyses for this end point

    Secondary: Tumour shrinkage

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    End point title
    		 Tumour shrinkage
    End point description
    Tumour shrinkage (in millimeters) is defined as the difference between the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of longest diameters of the same set of target lesions. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    from randomisation until database lock
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [14]
    99999 [15]
    Units: millimeters
        arithmetic mean (standard deviation)
    0 ( 0 )
    0 ( 0 )
    Notes
    [14] - ITT
    [15] - ITT
    No statistical analyses for this end point

    Secondary: Time to deterioration in Patient Reported Outcomes

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    End point title
    		 Time to deterioration in Patient Reported Outcomes
    End point description
    Time to deterioration in Patient Reported Outcomes (PROs) of: - cough ((European Organisation for Research and Treatment of Cancer) EORTC QLQ-LC13: Q1) - dyspnoea (EORTC QLQ-LC13: Q3-5 and EORTC QLQC30: Q8) - chest pain (EORTC QLQ-LC13: Q10) - NSCLC specific symptoms of NSCLC SAQ Deterioration is defined as the time from randomisation until the earliest of a 10-point worsening from baseline score or death. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants entered in the trial.
    End point type
    Secondary
    End point timeframe
    time from randomisation until database lock
    End point values
    		 BI 1482694 Platinum based doublet chemotherapy
    Number of subjects analysed
    99999 [16]
    99999 [17]
    Units: percentage of participants
        number (not applicable)
    99999
    99999
    Notes
    [16] - ITT
    [17] - ITT
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring after first intake of treatment through the Residual effect period.
    Adverse event reporting additional description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    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: No subjects entered in the trial hence results are not available.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2016
    The first official version of this clinical trial protocol was version 2.0 (revision 1), Shortly after finalization of CTP version 1.0, additional data became available which had to be included into the document before regulatory and IRB/EC submissions.
    06 Jul 2016
    Following sections were changed: - Abbreviations - Drug Profile - Benefit- Risk Assessment - 3.3.4.1 Removal of individual patients - Table of Dose Reduction Scheme for BI 1482694 - Management of dermatological AEs following treatment with BI 1482694 - Definitions of AEs - Published references - Clinical Evaluation of SJS/TEN Description of change:Addition of information on occurrence, grading, management and reporting of serious adverse skin reactions.

    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.
    Discontinued by Boehringer Ingelheim during preparation of trial. No patient entered the study, therefore no results data available.
    For support, Contact us.
    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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