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    Clinical Trial Results:
    Induction therapy with gefitinib followed by taxane platinum chemotherapy and intercalated gefitinib in NSCLC stages II-IIIB with activating EGFR mutation – A single arm Phase II trial.

    Summary
    EudraCT number
    		 2014-005595-28
    Trial protocol
    		 DE  
    Global end of trial date
    16 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2022
    First version publication date
    30 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AIO-TRK-0214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02326285
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AIO-Studien-gGmbH
    Sponsor organisation address
    Kuno-Fischer-Str. 8, Berlin, Germany, 14057
    Public contact
    AIO-Studien-gGmbH, AIO-Studien-gGmbH, +49 30814534431, info@aio-studien-ggmbh.de
    Scientific contact
    AIO-Studien-gGmbH, AIO-Studien-gGmbH, +49 30814534431, info@aio-studien-ggmbh.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
    16 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the pathologic complete remission rate (according to the Junker criteria regression IIB and III) after induction therapy with gefitinib D-12 to D -1 followed by docetaxel 75 mg/m² and cisplatin 50 mg/m2 D1+2 q21d (or paclitaxel 200 mg/m² D1 and carboplatin AUC 6.0 D1) and intercalated gefitinib 250 mg D4 to D20 (cycles 1 + 2) and D4-D17 (cycle 3) in mediastinal/hilar lymph nodes as well as primary tumor.
    Protection of trial subjects
    This study was planned, analyzed and conducted according to the study protocol and in accordance with the International Conference on Harmonization (ICH) ‚Guideline for Good Clinical Practice E6(R1)‘, CPMP/ICH/135/95, based on the principles of the Declaration of Helsinki (1964) and its October 1996 amendment (Somerset West, South Africa). The study was duly conducted in compliance with the German Arzneimittelgesetz (AMG; German Drug Law), and the corresponding Directive 2001/20/EC. Subjects were fully informed regarding all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 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
    Germany: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of 39 patients pre-screened between November 2015 and March 2017, 37 were assessed for EGFR mutation status. Only one of the these was tested positive for an EGFR mutation.

    Pre-assignment
    Screening details
    		 Of 39 patients pre-screened between November 2015 and March 2017, 37 were assessed for EGFR mutation status. Only one of the these was tested positive for an EGFR mutation.

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

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 Per protocol, treatment was to be administered in three cycles of a duration of three weeks each. Per protocol treatment started with 12 days of gefitinib at 250 mg/day p.o. (D-12 to -1) and subsequent induction with doublet chemotherapy of docetaxel 75 mg/m2 i.v. on D1 and cisplatin 50 mg/m2 i.v. on D1 and 2. Gefitinib was to be given daily on D4 to D20 of the first two cycles. In the third cycle, gefitinib was administered on D4 to D17. Surgery was planned to take place within the 4th week after D1 of the last cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Three cycles at 75 mg/m2 on Day 1

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Three cycles at 50 mg/m2 on Day 1+2

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 days of induction treatment, followed by three cycles of intercalated gefitinib at 250 mg/day on Days 4-20 (cycles 1 and 2) or Days 4-17 (cycle 3).

    Number of subjects in period 1
    		Overall trial
    Started
    1
    Completed
    1

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Per protocol, treatment was to be administered in three cycles of a duration of three weeks each. Per protocol treatment started with 12 days of gefitinib at 250 mg/day p.o. (D-12 to -1) and subsequent induction with doublet chemotherapy of docetaxel 75 mg/m2 i.v. on D1 and cisplatin 50 mg/m2 i.v. on D1 and 2. Gefitinib was to be given daily on D4 to D20 of the first two cycles. In the third cycle, gefitinib was administered on D4 to D17. Surgery was planned to take place within the 4th week after D1 of the last cycle.

    Primary: Rate of pathologic complete remissions (pCR) of hilar and mediastinal lymph nodes after induction CTx + surgery

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    End point title
    		 Rate of pathologic complete remissions (pCR) of hilar and mediastinal lymph nodes after induction CTx + surgery [1]
    End point description
    Primary endpoint was the regression grading by Junker of hilar and mediastinal lymph nodes. For both lymph nodes, regression was rated with grade III, i.e. pathologic complete remission (pCR) was achieved.
    End point type
    Primary
    End point timeframe
    From baseline until surgery
    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 statistical analyses were carried out. The data set generated by a single patient is too small for meaningful analysis.
    End point values
    		 Overall trial
    Number of subjects analysed
    1
    Units: pCR rate
        Pathologic complete remission (pCR)
    1
        No pCR
    0
    No statistical analyses for this end point

    Secondary: R0 resection rate

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    End point title
    		 R0 resection rate
    End point description
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 Overall trial
    Number of subjects analysed
    1
    Units: R0 resection rate
        R0 resection
    1
        Other
    0
    No statistical analyses for this end point

    Secondary: Regression grading of the primary tumor according to the Junker criteria

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    End point title
    		 Regression grading of the primary tumor according to the Junker criteria
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline until surgery
    End point values
    		 Overall trial
    Number of subjects analysed
    1
    Units: Regression grading
        Grade IIa
    1
        Other
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of informed consent until study termination by sponsor: September 2016 - March 2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chronic fatigue syndrome
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2016
    Several smaller improvements to the study protocol were made: - Inclusion criteria slightly extended (e.g., added eligibility for cytologically confirmed disease, not only histologic confirmation) - Edits to schedule of assessments (time points changed for some assessments, and some assessments added, e.g. full blood count, ALT, bilirubin, GFR) - Some clarifications added (e.g., that tumor surgery is not a study procedure)

    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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