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    Clinical Trial Results:
    A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma

    Summary
    EudraCT number
    		 2014-001992-30
    Trial protocol
    		 GB  
    Global end of trial date
    08 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2023
    First version publication date
    22 Sep 2023
    Other versions
    Summary report(s)
    		 VIM manuscript eClinMed

    Trial information

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    Trial identification
    Sponsor protocol code
    UNOLE 0329
    Additional study identifiers
    ISRCTN number
    		 ISRCTN44518069
    US NCT number
    		 NCT02139904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    Research Governance Office, Academic Department, Leicester General Hospital, Leicester, United Kingdom, LE5 4PW
    Public contact
    Sarah Bridges, Wales Cancer Trials Unit, +44 02920687581, bridgesse@cardiff.ac.uk
    Scientific contact
    Sarah Bridges, Wales Cancer Trials Unit, +44 02920687581, bridgesse@cardiff.ac.uk
    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
    17 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to determine whether treatment with vinorelbine in patients with malignant mesothelioma improves overall survival.
    Protection of trial subjects
    Regular IDMC meetings were held for review of safety and recruitment
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    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
    United Kingdom: 154
    Worldwide total number of subjects
    154
    EEA total number of subjects
    154
    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)
    36
    From 65 to 84 years
    117
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 225 patients were screened. 48 were ineligible: 27 did not meet inclusion criteria, 5 died and 16 for unknown reasons. 23 were eligible but not randomised: 17 declined to participate,1 entered an alternative trial, 1 was unwilling to travel and 4 for unknown reasons.

    Pre-assignment period milestones
    Number of subjects started
    		 154
    Number of subjects completed
    		 154

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ASC alone
    Arm description
    		 Standard of care treatment only
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ASC plus vinorelbine
    Arm description
    		 Standard of care plus vinorelbine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Vinorelbine was administered at a dose of 60mg/m2 orally weekly for the first cycle (days 1, 8 and 15) on a 3-weekly cycle. Subsequent doses could be increased to 80mg/m2 (day 22) if there had been no haematological toxicity (neutrophil count dropped once below 0.5 x 109/L or more than once between 0.5 and 1.0 x 109/L during the first three administrations at 60mg/m²). Even for patients with BSA > 2 m2 the total dose should never exceed 120 mg per week at 60 mg /m2 and 160 mg per week at 80 mg/m2. Dosing continued on a weekly schedule until progression or unacceptable toxicity.

    Number of subjects in period 1
    		ASC alone ASC plus vinorelbine
    Started
    56
    98
    Completed
    49
    87
    Not completed
    7
    11
         Consent withdrawn by subject
    4
    1
         Physician decision
    1
    2
         Adverse event, non-fatal
    -
    3
         Unknown
    -
    1
         Lost to follow-up
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASC alone
    Reporting group description
    		 Standard of care treatment only

    Reporting group title
    ASC plus vinorelbine
    Reporting group description
    		 Standard of care plus vinorelbine

    Reporting group values
    		 ASC alone ASC plus vinorelbine Total
    Number of subjects
    		 56 98 154
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 70.7 (66.6 to 74.2) 70.5 (65.4 to 76.4) -
    Gender categorical
    Units: Subjects
        Female
    		 11 18 29
        Male
    		 45 80 125
    ECOG Performance status
    Units: Subjects
        Zero
    		 12 26 38
        One
    		 44 71 115
        Missing
    		 1 1
    Mesothelioma type
    Units: Subjects
        Epithelioid
    		 48 81 129
        Biphasic or sarcomatoid
    		 3 13 16
        NOS
    		 5 3 8
        Missing
    		 0 1 1
    Best response during first line therapy
    Units: Subjects
        DCR (Complete response, partial response or stable
    		 40 73 113
        Progressive disease
    		 16 24 40
        Missing
    		 0 1 1
    Smoking status
    Units: Subjects
        Smoker
    		 2 6 8
        Non-smoker
    		 19 40 59
        Ex-smoker
    		 34 52 86
        Missing
    		 1 0 1
    Asbestos history
    Units: Subjects
        Yes
    		 47 80 127
        No
    		 6 17 23
        Missing
    		 3 1 4
    T stage
    Units: Subjects
        T1
    		 8 10 18
        T2
    		 13 10 23
        T3
    		 21 35 56
        T4
    		 12 37 49
        Tis
    		 0 1 1
        TX
    		 1 1 2
        Missing
    		 1 4 5
    N stage
    Units: Subjects
        N0
    		 26 49 75
        N1
    		 11 8 19
        N2
    		 15 32 47
        N3
    		 2 4 6
        NX
    		 1 1 2
        Missing
    		 1 4 5
    M stage
    Units: Subjects
        M0
    		 46 77 123
        M1
    		 7 15 22
        Missing
    		 3 6 9
    Extra-thoracic metastases
    Units: Subjects
        Yes
    		 5 7 12
        No
    		 50 89 139
        Missing
    		 1 2 3
    BSA
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    		 1.9 (1.8 to 2.0) 1.9 (1.8 to 2.1) -
    Subject analysis sets

    Subject analysis set title
    ASC alone
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients to receive active symptom control only

    Subject analysis set title
    ASC plus vinorelbine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients to receive active symptom control and vinorelbine

    Subject analysis sets values
    		 ASC alone ASC plus vinorelbine
    Number of subjects
    56
    98
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    70.7 (66.6 to 74.2)
    70.5 (65.4 to 76.4)
    Gender categorical
    Units: Subjects
        Female
    11
    18
        Male
    45
    80
    ECOG Performance status
    Units: Subjects
        Zero
    12
    26
        One
    44
    71
        Missing
    1
    Mesothelioma type
    Units: Subjects
        Epithelioid
    48
    81
        Biphasic or sarcomatoid
    3
    13
        NOS
    5
    3
        Missing
    0
    1
    Best response during first line therapy
    Units: Subjects
        DCR (Complete response, partial response or stable
    40
    73
        Progressive disease
    16
    24
        Missing
    0
    1
    Smoking status
    Units: Subjects
        Smoker
    2
    6
        Non-smoker
    19
    40
        Ex-smoker
    34
    52
        Missing
    1
    0
    Asbestos history
    Units: Subjects
        Yes
    47
    80
        No
    6
    17
        Missing
    3
    1
    T stage
    Units: Subjects
        T1
    8
    10
        T2
    13
    10
        T3
    21
    35
        T4
    12
    37
        Tis
    0
    1
        TX
    1
    1
        Missing
    1
    4
    N stage
    Units: Subjects
        N0
    26
    49
        N1
    11
    8
        N2
    15
    32
        N3
    2
    4
        NX
    1
    1
        Missing
    1
    4
    M stage
    Units: Subjects
        M0
    46
    77
        M1
    7
    15
        Missing
    3
    6
    Extra-thoracic metastases
    Units: Subjects
        Yes
    5
    7
        No
    50
    89
        Missing
    1
    2
    BSA
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    1.9 (1.8 to 2.0)
    1.9 (1.8 to 2.1)

    End points

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    End points reporting groups
    Reporting group title
    ASC alone
    Reporting group description
    		 Standard of care treatment only

    Reporting group title
    ASC plus vinorelbine
    Reporting group description
    		 Standard of care plus vinorelbine

    Subject analysis set title
    ASC alone
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients to receive active symptom control only

    Subject analysis set title
    ASC plus vinorelbine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients to receive active symptom control and vinorelbine

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Primary
    End point timeframe
    Time from randomisation to any disease progression and/or any death, defined according to Modified RECIST. Patients who were event free will be censored at the date of their last evaluable RECIST assessment.
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time to event (months)
        median (inter-quartile range (Q1-Q3))
    2.8 (1.4 to 4.1)
    4.2 (2.2 to 8)
    Statistical analysis title
    		 Progression-free survival
    Comparison groups
    ASC alone v ASC plus vinorelbine
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.86

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to death
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time from randomization to death (months
        median (inter-quartile range (Q1-Q3))
    9.1 (5.7 to 14.1)
    9.3 (6.7 to 11.8)
    Statistical analysis title
    		 Overall survival
    Comparison groups
    ASC alone v ASC plus vinorelbine
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.237
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.17

    Secondary: Objective response

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    End point title
    		 Objective response
    End point description
    End point type
    Secondary
    End point timeframe
    Best response from randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Subjects
        Complete response
    0
    1
        Partial response
    2
    4
        Stable disease
    25
    60
        Progressive disease
    17
    18
        Did not reach first assessment time point
    7
    8
        Missing
    5
    7
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response rate (ORR) will be based on Modified RECIST. ORR is defined as the proportion of participants whose best response was complete response (CR) or partial response (PR)
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Subjects
        Complete response/partial response
    2
    5
    Statistical analysis title
    		 Objective response rate odds ratio
    Comparison groups
    ASC alone v ASC plus vinorelbine
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.89
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 5.51

    Secondary: Clinical benefit rate

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    End point title
    		 Clinical benefit rate
    End point description
    CBR (also referred to as disease control rate (DCR)) will be defined as the proportion of patients with CR, PR or stable disease (SD) at 12 weeks
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Subjects
        CR, PR or stable disease
    27
    65
    Statistical analysis title
    		 Clinical benefit rate odds ratio
    Comparison groups
    ASC alone v ASC plus vinorelbine
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 4.24

    Secondary: Duration of response overall

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    End point title
    		 Duration of response overall
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time (months)
        median (inter-quartile range (Q1-Q3))
    3.5 (2.8 to 4.2)
    7.2 (3.9 to 8.5)
    No statistical analyses for this end point

    Secondary: Duration of partial response

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    End point title
    		 Duration of partial response
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time (months)
        median (inter-quartile range (Q1-Q3))
    3.5 (2.8 to 4.2)
    7.8 (5.1 to 11.3)
    No statistical analyses for this end point

    Secondary: Duration of stable disease

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    End point title
    		 Duration of stable disease
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time (months)
        median (inter-quartile range (Q1-Q3))
    3.7 (2.8 to 4.2)
    4.2 (2.8 to 5.9)
    No statistical analyses for this end point

    Secondary: Duration of response according to ORR

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    End point title
    		 Duration of response according to ORR
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time (months)
        median (inter-quartile range (Q1-Q3))
    3.5 (2.8 to 4.2)
    7.2 (3.9 to 8.5)
    No statistical analyses for this end point

    Secondary: Duration of response according to clinical benefit rate

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    End point title
    		 Duration of response according to clinical benefit rate
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of follow up
    End point values
    		 ASC alone ASC plus vinorelbine
    Number of subjects analysed
    56
    98
    Units: Time (months)
        median (inter-quartile range (Q1-Q3))
    3.7 (2.8 to 4.2)
    4.2 (2.8 to 6.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation to end of follow up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    ASC alone - safety population
    Reporting group description
    		 -

    Reporting group title
    ASC plus vinorelbine-safety population
    Reporting group description
    		 -

    Serious adverse events
    		 ASC alone - safety population ASC plus vinorelbine-safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 51 (19.61%)
    31 / 96 (32.29%)
         number of deaths (all causes)
    38
    70
         number of deaths resulting from adverse events
    2
    2
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac other: Blocked IVC and SVC
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Motor neuropathy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculitis brachial
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 96 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 51 (0.00%)
    5 / 96 (5.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Pneumothorax
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 96 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 51 (5.88%)
    5 / 96 (5.21%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Neutropenic sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ASC alone - safety population ASC plus vinorelbine-safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 51 (58.82%)
    81 / 96 (84.38%)
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 51 (5.88%)
    6 / 96 (6.25%)
         occurrences all number
    4
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 51 (5.88%)
    8 / 96 (8.33%)
         occurrences all number
    5
    9
    Nervous system disorders
    Sensory neuropathy
         subjects affected / exposed
    1 / 51 (1.96%)
    7 / 96 (7.29%)
         occurrences all number
    4
    16
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 51 (9.80%)
    23 / 96 (23.96%)
         occurrences all number
    7
    86
    Lymphopenia
         subjects affected / exposed
    2 / 51 (3.92%)
    16 / 96 (16.67%)
         occurrences all number
    3
    33
    Neutropenia
         subjects affected / exposed
    0 / 51 (0.00%)
    18 / 96 (18.75%)
         occurrences all number
    0
    29
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 51 (21.57%)
    50 / 96 (52.08%)
         occurrences all number
    34
    146
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 51 (1.96%)
    15 / 96 (15.63%)
         occurrences all number
    1
    34
    Constipation
         subjects affected / exposed
    4 / 51 (7.84%)
    38 / 96 (39.58%)
         occurrences all number
    5
    59
    Diarrhoea
         subjects affected / exposed
    2 / 51 (3.92%)
    24 / 96 (25.00%)
         occurrences all number
    3
    40
    Flatulence
         subjects affected / exposed
    1 / 51 (1.96%)
    7 / 96 (7.29%)
         occurrences all number
    1
    20
    Nausea
         subjects affected / exposed
    2 / 51 (3.92%)
    22 / 96 (22.92%)
         occurrences all number
    6
    46
    Vomiting
         subjects affected / exposed
    2 / 51 (3.92%)
    9 / 96 (9.38%)
         occurrences all number
    2
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 51 (23.53%)
    21 / 96 (21.88%)
         occurrences all number
    24
    32
    Dyspnoea
         subjects affected / exposed
    9 / 51 (17.65%)
    31 / 96 (32.29%)
         occurrences all number
    26
    83
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 51 (1.96%)
    10 / 96 (10.42%)
         occurrences all number
    1
    31
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 51 (3.92%)
    7 / 96 (7.29%)
         occurrences all number
    4
    16
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 51 (5.88%)
    11 / 96 (11.46%)
         occurrences all number
    5
    18
    Chest pain
         subjects affected / exposed
    5 / 51 (9.80%)
    14 / 96 (14.58%)
         occurrences all number
    10
    24
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 51 (3.92%)
    7 / 96 (7.29%)
         occurrences all number
    2
    7
    Lower respiratory tract infection
         subjects affected / exposed
    6 / 51 (11.76%)
    11 / 96 (11.46%)
         occurrences all number
    8
    13
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    5 / 51 (9.80%)
    22 / 96 (22.92%)
         occurrences all number
    8
    55

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2015
    Amendment to protocol V2 Additional sites: University Hospital Southampton NHS Foundation Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Brighton & Sussex Univ. Hospitals NHS Trust, University Hospital of North Midlands NHS Trust. Change of PI from Dr Noelle O’Rourke to Dr Nicole Steele at The Beatson REC Approval 10/03/2015 HRA Approval 4/4/2016
    06 Mar 2015
    Protocol V2.0 – V3.0. Inclusion criteria no 1 modified. Drug Supply, Distribution and Storage section updated. REC approval 13/04/2015 Not submitted to HRA MHRA rejected 02/04/2015
    15 Apr 2015
    Protocol V3.0 – V4.0. Two new exclusion criteria added, One existing exclusion criteria updated. A section has been removed from Medications/Procedures permitted with caution, and moved to Non-permitted concomitant medications/procedures. Pregnancy has been added as a withdrawal reason. REC approval 18/05/2015 Not submitted to HRA MHRA approval 20/04/2015
    16 Nov 2015
    Protocol V4.0 – V5.0. Widespread updates to the protocol, see amendment log. GP letter V1.0 – V2.0. Addition of permitted and non-permitted medications/procedures, and possible drug interactions. REC approval 30/11/2015 MHRA approval 15/12/2015
    17 Jan 2017
    Protocol V5.0 – 6.0. Exclusion Criteria no 2 from protocol V5.0 removed for Protocol V6.0. Trial staff changes. Safety reporting procedures and randomisation number changed. Minor typo errors. Modified RECIST has been clarified. PIS V3.0 – V4.0. Tests that a patient may receive has been changed from a list to a more generalised paragraph as recommended by the Pt Rep on the TMG. MHRA rejected 20/02/2017
    12 Apr 2017
    Addition of: University Hospitals of Morecambe Bay NHS Foundation Trust REC approval26/04/2017 HRA approval 02/05/2017
    21 Apr 2017
    Protocol V6.0 – 7.0 Exclusion Criteria no 2 (to remove 30 day wash out period for drugs) which was removed for protocol V6 and was rejected by MHRA has now been added back in to the protocol as requested by the MHRA. MHRA also rejected a change of neutrophil count so the neutrophil count is back to its original value as when it was initially approved by the MHRA. Ethics approved both protocol and PIS but these will both be resubmitted again due to the protocol version number will have to change to V7.0 REC approval 12/05/2017 HRA approval 19/06/2017 MHRA approval 08/06/2017
    03 Jul 2017
    Additional site Shrewsbury and Telford NHS Trust REC approval 3/7/2017 HRA approval 11/07/2017
    21 Jul 2017
    Additional site Derby and Teaching Hospitals NHS foundation Trust REC approval 25/07/17 HRA approval 10/08/17
    22 Sep 2017
    Addition of Southend University Hospital
    30 Apr 2018
    Change of PI from Dr Marianne Nicholson to Dr Gillian Price at Aberdeen Royal Infirmary
    10 Sep 2018
    Protocol V8.0 change of endpoint from OS to PFS REC approval 12/10/18 HRA approval 22/10/18 MHRA approval 8/10/18

    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/35706488
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