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    Clinical Trial Results:
    A Phase II, Open-Label Trial of Bortezomib (Velcade®) in Combination with Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

    Summary
    EudraCT number
    2006-004963-68
    Trial protocol
    GR  
    Global end of trial date
    25 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Jul 2019
    First version publication date
    10 Jul 2019
    Other versions
    Summary report(s)
    Bortezomib Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    26866138-LUC-2006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Hellenic Oncology Research Group
    Sponsor organisation address
    Gr. Theologou 5, Athens, Greece, 11471
    Public contact
    Evagelia Ageli, Hellenic Oncology Research Group, secretary@horg.gr
    Scientific contact
    Vasilis Georgoulias, Hellenic Oncology Research Group, georgouliasv@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
    13 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to establish the objective response rate (complete response [CR] + partial response [PR]) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced Stage IIIb not amenable to curative treatment or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease.
    Protection of trial subjects
    none
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Jul 2009
    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
    Greece: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    18
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Pts with stage IIIB or metastatic (stage IV) NSCLC , age ≥18 years, measurable disease according to RECIST vrs 1.0, life expectancy >3 months, and ECOG performance status of 0–1.

    Pre-assignment
    Screening details
    One prior line of anti-neoplastic therapy allowed if given as adjuvant or neo-adjuvant, at least 6 months earlier.

    Period 1
    Period 1 title
    Entire trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Intent to treat subjects
    Arm description
    One arm with all subjects participating into the Trial and have signed ICF
    Arm type
    Experimental

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    179324-69-7
    Other name
    velcade
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 mg/m2 i.v. on days 1 and 8, and starting on day 21 (cycle 2), bortezomib (days 1 and 8) in combination with gemcitabine 1000 mg/m2, (days 1 and 8), and cisplatin 70 mg/m2 (day 1) in cycles of 21 days. Up to 8 cycles of combination therapy could be administered; single-agent bortezomib was continued until disease progression or unacceptable toxicity.

    Number of subjects in period 1
    Intent to treat subjects
    Started
    53
    Completed
    43
    Not completed
    10
         Physician decision
    2
         Adverse event, serious fatal
    5
         Consent withdrawn by subject
    1
         Lost to follow-up
    2

    Baseline characteristics

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

    Reporting group values
    Entire trial Total
    Number of subjects
    53 53
    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)
    17 17
        From 65-84 years
    36 36
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    66 (49 to 77) -
    Gender categorical
    Units: Subjects
        Female
    11 11
        Male
    42 42
    Subject analysis sets

    Subject analysis set title
    Efficacy of Bortezomib
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Pts with histologically or cytologically confirmed, locally advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior systemic anti-neoplastic therapy for stage IIIB/IV disease was not allowed (one prior line was allowed if given as adjuvant or neo-adjuvant therapy at least 6 months earlier). Age ≥18 years with measurable disease according to RECIST version 1.1 Criteria, life expectancy >3 months, and ECOG performance status of 0–1. All patients treated at least for 1 cycle with the IMP and evaluated according to RECIST criteria version 1.1, were included into this analysis set.

    Subject analysis sets values
    Efficacy of Bortezomib
    Number of subjects
    43
    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)
    16
        From 65-84 years
    27
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    64 (49 to 77)
    Gender categorical
    Units: Subjects
        Female
    9
        Male
    34

    End points

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    End points reporting groups
    Reporting group title
    Intent to treat subjects
    Reporting group description
    One arm with all subjects participating into the Trial and have signed ICF

    Subject analysis set title
    Efficacy of Bortezomib
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Pts with histologically or cytologically confirmed, locally advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior systemic anti-neoplastic therapy for stage IIIB/IV disease was not allowed (one prior line was allowed if given as adjuvant or neo-adjuvant therapy at least 6 months earlier). Age ≥18 years with measurable disease according to RECIST version 1.1 Criteria, life expectancy >3 months, and ECOG performance status of 0–1. All patients treated at least for 1 cycle with the IMP and evaluated according to RECIST criteria version 1.1, were included into this analysis set.

    Primary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR) [1]
    End point description
    Objective response rate (ORR) is defined as the percentage (%) of patients that achieved Complete response (CR) or Partial response (PR) to the treatment, as measured by RECIST 1.1 CRITERIA. ORR= (CR+PR)/total number of patients, expressed as % percentage.
    End point type
    Primary
    End point timeframe
    July 2009 - April 2013
    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 2 step Simon's design that yields a type I error rate of 0.05 and power of 80% when the true overall response rate is 40% was used. The null hypothesis will be rejected if 12 or more responses are observed in 43 evaluable pts. This is an one arm trial that compares ORR with bibliographic data. The system does keeps asking for comparison group.
    End point values
    Intent to treat subjects Efficacy of Bortezomib
    Number of subjects analysed
    53
    43
    Units: % of complete and partial responses
    9
    9
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)

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    End point title
    Progression free survival (PFS)
    End point description
    PFS was measured from the first day of treatment until the day of the first evidence of disease progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    July 2009 - April 2013
    End point values
    Intent to treat subjects Efficacy of Bortezomib
    Number of subjects analysed
    53
    43
    Units: months
        median (full range (min-max))
    2.5 (0.3 to 48.1)
    3.8 (1.1 to 48.1)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    OS was measured from the first day of treatment until death or last follow-up.
    End point type
    Secondary
    End point timeframe
    July 2009 -April 2013
    End point values
    Intent to treat subjects Efficacy of Bortezomib
    Number of subjects analysed
    53
    43
    Units: months
        median (full range (min-max))
    10.6 (0.4 to 48.1)
    10.8 (1.7 to 48.1)
    Attachments
    OS Kaplan Meier
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    July 2009 - April 2013
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Bortezomib treated patients
    Reporting group description
    -

    Serious adverse events
    Bortezomib treated patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 53 (81.13%)
         number of deaths (all causes)
    46
         number of deaths resulting from adverse events
    2
    Vascular disorders
    thromboembolism
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    12 / 53 (22.64%)
         occurrences causally related to treatment / all
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    13 / 53 (24.53%)
         occurrences causally related to treatment / all
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
    Additional description: one patient was hospitalized with grade 4 thrombocytopenia after the second cycle, and died due to pulmonary hemorrhage and respiratory failure type II
         subjects affected / exposed
    9 / 53 (16.98%)
         occurrences causally related to treatment / all
    9 / 9
         deaths causally related to treatment / all
    1 / 1
    Febrile neutropenia
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    hearing disorders
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    AST/ALT ratio
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
    Additional description: Sepsis and polyorganic failure
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    Bortezomib treated patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 53 (100.00%)
    Immune system disorders
    allergy
         subjects affected / exposed
    4 / 53 (7.55%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    18 / 53 (33.96%)
         occurrences all number
    18
    Leukopenia
         subjects affected / exposed
    18 / 53 (33.96%)
         occurrences all number
    18
    Anaemia
         subjects affected / exposed
    45 / 53 (84.91%)
         occurrences all number
    45
    Thrombocytopenia
         subjects affected / exposed
    19 / 53 (35.85%)
         occurrences all number
    19
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    8 / 53 (15.09%)
         occurrences all number
    8
    Eye disorders
    visual disorders
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Ear and labyrinth disorders
    hearing disorders
         subjects affected / exposed
    5 / 53 (9.43%)
         occurrences all number
    5
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    19 / 53 (35.85%)
         occurrences all number
    19
    Fatigue
         subjects affected / exposed
    31 / 53 (58.49%)
         occurrences all number
    31
    fever
         subjects affected / exposed
    13 / 53 (24.53%)
         occurrences all number
    13
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    7 / 53 (13.21%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    6 / 53 (11.32%)
         occurrences all number
    6
    mucositis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Renal and urinary disorders
    nephrotoxicity
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 53 (11.32%)
         occurrences all number
    6
    Edema
         subjects affected / exposed
    8 / 53 (15.09%)
         occurrences all number
    8
    Infections and infestations
    Infection
         subjects affected / exposed
    10 / 53 (18.87%)
         occurrences all number
    10

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/26994909
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