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    Clinical Trial Results:
    A Phase IIIB, Single Arm Study, of Durvalumab in Combination with Platinum-Etoposide for Untreated Patients with Extensive-Stage Small Cell Lung Cancer reflecting Real World Clinical Practice in Spain (CANTABRICO).

    Summary
    EudraCT number
    		 2020-002328-35
    Trial protocol
    		 ES  
    Global end of trial date
    21 Jun 2023

    Results information
    Results version number
    		 v1
    This version publication date
    05 Jul 2024
    First version publication date
    05 Jul 2024
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    D419QC00005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04712903
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Puerto de Somport 21-23, Madrid, Spain, 28050
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.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
    12 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe safety profile of durvalumab in combination with platinum–etoposide as first-line treatment for patients with ES-SCLC
    Protection of trial subjects
    The patient signed the informed consent before carrying out any procedure related to the study. Physical examination, hematology, biochemistry, ECG and evaluation of the tumor were made before the inclusion of the patient in the study and during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2020
    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
    Spain: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    44
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 126 patients included in the study, 25 were screening failures and 101 patients have been analysed. All patients included in the analysis started treatment with chemotherapy and durvalumab and 81 of them started maintenance treatment with durvalumab.

    Pre-assignment
    Screening details
    		 All patients that met selection critera and sigend the informed consent form were included in the study.

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

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 Received study intervention
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab 1500 mgvia IV infusion over 60minutes on Day 1 ofeach cycle.

    Number of subjects in period 1
    		Experimental arm
    Started
    101
    Completed
    101

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Received study intervention

    Reporting group values
    		 Experimental arm Total
    Number of subjects
    		 101 101
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 44 44
        >=65 years
    		 57 57
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.2 ( 7.2 ) -
    Sex: Female, Male
    Units:
        Female
    		 33 33
        Male
    		 68 68
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 21 21
        Not Hispanic or Latino
    		 80 80
        Unknown or Not Reported
    		 0 0
    Smoking status
    Units: Subjects
        Current smoker
    		 46 46
        Former smoker
    		 53 53
        Not available
    		 2 2
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 75.6 ( 16.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Received study intervention

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Subject analysis set title
    Completed
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Completed the items in the questionnaire.

    Primary: Incidence of adverse events (AEs) grade ≥ 3

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    End point title
    		 Incidence of adverse events (AEs) grade ≥ 3 [1]
    End point description
    Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
    End point type
    Primary
    End point timeframe
    During study treatment
    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: Single arm, descriptive.
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Participants
        Yes
    77
        No
    24
    No statistical analyses for this end point

    Primary: Incidence of immune-mediated adverse events (imAE)

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    End point title
    		 Incidence of immune-mediated adverse events (imAE) [2]
    End point description
    Patients with immune-mediated adverse events (imAE) per patient
    End point type
    Primary
    End point timeframe
    During study treatment
    Notes
    [2] - 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: Single arm, descriptive.
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Participants
        Yes
    38
        No
    63
    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: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.
    End point type
    Secondary
    End point timeframe
    At least every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Months
        median (confidence interval 95%)
    6.1 (5.2 to 6.9)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Patients who achieve a complete or partial response during study treatment.
    End point type
    Secondary
    End point timeframe
    At least every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    54.5 (44.7 to 64.2)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
    End point type
    Secondary
    End point timeframe
    At least every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    55
    Units: Months
        median (confidence interval 95%)
    5.6 (4.7 to 6.5)
    No statistical analyses for this end point

    Secondary: Time to Treatment Discontinuation (TTD)

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    End point title
    		 Time to Treatment Discontinuation (TTD)
    End point description
    TTD: Defined as the time from the first date of treatment until the end of treatment date.
    End point type
    Secondary
    End point timeframe
    From start of treatment until end of treatment.
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Months
        median (inter-quartile range (Q1-Q3))
    6.2 (4.5 to 9.9)
    No statistical analyses for this end point

    Secondary: Overal Survival (OS)

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    End point title
    		 Overal Survival (OS)
    End point description
    OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Months
        median (confidence interval 95%)
    9.6 (7.8 to 11.3)
    No statistical analyses for this end point

    Secondary: PFS rate at 6 months

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    End point title
    		 PFS rate at 6 months
    End point description
    Proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    53.0 (43.2 to 62.8)
    No statistical analyses for this end point

    Secondary: PFS rate at 12 months

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    End point title
    		 PFS rate at 12 months
    End point description
    Proportion of participants remaining alive without disease progression at 12 months after initiation of study treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    21.0 (13.0 to 29.0)
    No statistical analyses for this end point

    Secondary: QLQ-C30: Global Health Status, change from baseline

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    End point title
    		 QLQ-C30: Global Health Status, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    67
    Units: Units
        arithmetic mean (standard deviation)
    -6.3 ( 30.8 )
    No statistical analyses for this end point

    Secondary: OS rate at 18 months

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    End point title
    		 OS rate at 18 months
    End point description
    Proportion of participants remaining alive at 18 months after initiation of study treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    31.6 (22.4 to 40.8)
    No statistical analyses for this end point

    Secondary: OS rate at 12 months

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    End point title
    		 OS rate at 12 months
    End point description
    Proportion of participants remaining alive at 12 months after initiation of study treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    40.7 (31.1 to 50.3)
    No statistical analyses for this end point

    Secondary: DoR rate at 12 months

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    End point title
    		 DoR rate at 12 months
    End point description
    Proportion of responders remaining alive without disease progression at 12 months after first response.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    55
    Units: Percentage
        number (confidence interval 95%)
    35.7 (23.0 to 48.4)
    No statistical analyses for this end point

    Secondary: OS rate at 6 months

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    End point title
    		 OS rate at 6 months
    End point description
    Proportion of participants remaining alive at 6 months after initiation of study treatment.
    End point type
    Secondary
    End point timeframe
    Every 12 weeks
    End point values
    		 Experimental arm
    Number of subjects analysed
    101
    Units: Percentage
        number (confidence interval 95%)
    75.2 (66.8 to 83.6)
    No statistical analyses for this end point

    Secondary: QLQ-C30: Physical Functioning, change from baseline

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    End point title
    		 QLQ-C30: Physical Functioning, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -15.0 ( 29.4 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Role Functioning, change from baseline

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    End point title
    		 QLQ-C30: Role Functioning, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -17.0 ( 36.0 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Emotional Functioning, change from baseline

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    End point title
    		 QLQ-C30: Emotional Functioning, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -2.3 ( 30.4 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Cognitive Functioning, change from baseline

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    End point title
    		 QLQ-C30: Cognitive Functioning, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -15.0 ( 24.0 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Social Functioning, change from baseline

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    End point title
    		 QLQ-C30: Social Functioning, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    67
    Units: Units
        arithmetic mean (standard deviation)
    -12.0 ( 31.0 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Insomnia, change from baseline

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    End point title
    		 QLQ-C30: Insomnia, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    68
    Units: Units
        arithmetic mean (standard deviation)
    1.0 ( 36.4 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Dyspnea, change from baseline

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    End point title
    		 QLQ-C30: Dyspnea, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -2.4 ( 37.2 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Nausea, change from baseline

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    End point title
    		 QLQ-C30: Nausea, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    0.7 ( 20.1 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Pain, change from baseline

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    End point title
    		 QLQ-C30: Pain, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    0.2 ( 29.2 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Fatigue, change from baseline

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    End point title
    		 QLQ-C30: Fatigue, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    12.4 ( 29.4 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Anorexia, change from baseline

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    End point title
    		 QLQ-C30: Anorexia, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    -2.4 ( 36.3 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Constipation, change from baseline

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    End point title
    		 QLQ-C30: Constipation, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    6.3 ( 33.5 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Diarrhea, change from baseline

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    End point title
    		 QLQ-C30: Diarrhea, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    69
    Units: Units
        arithmetic mean (standard deviation)
    0.0 ( 18.1 )
    No statistical analyses for this end point

    Secondary: QLQ-C30: Financial difficulties, change from baseline

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    End point title
    		 QLQ-C30: Financial difficulties, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    65
    Units: Units
        arithmetic mean (standard deviation)
    10.3 ( 22.0 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Cough, change from baseline

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    End point title
    		 QLQ-LC13: Cough, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    73
    Units: Units
        arithmetic mean (standard deviation)
    -7.8 ( 29.7 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Haemoptysis, change from baseline

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    End point title
    		 QLQ-LC13: Haemoptysis, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    73
    Units: Units
        arithmetic mean (standard deviation)
    -0.5 ( 15.2 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Dyspnea, change from baseline

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    End point title
    		 QLQ-LC13: Dyspnea, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    68
    Units: Units
        arithmetic mean (standard deviation)
    3.1 ( 24.1 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Sore mouth

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    End point title
    		 QLQ-LC13: Sore mouth
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    71
    Units: Units
        arithmetic mean (standard deviation)
    2.3 ( 13.0 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Other Pain, change from baseline

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    End point title
    		 QLQ-LC13: Other Pain, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    68
    Units: Units
        arithmetic mean (standard deviation)
    7.4 ( 39.4 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Pain in arm, change from baseline

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    End point title
    		 QLQ-LC13: Pain in arm, change from baseline
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks during chemotherapy treatment and every 4 weeks during maintenance treatment.
    End point values
    		 Completed
    Number of subjects analysed
    71
    Units: Units
        arithmetic mean (standard deviation)
    3.3 ( 33.4 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Alopecia

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    End point title
    		 QLQ-LC13: Alopecia
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    72
    Units: Units
        arithmetic mean (standard deviation)
    18.1 ( 37.5 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Dysphagia

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    End point title
    		 QLQ-LC13: Dysphagia
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    72
    Units: Units
        arithmetic mean (standard error)
    2.8 ( 23.6 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Neuropathy

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    End point title
    		 QLQ-LC13: Neuropathy
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    71
    Units: Units
        arithmetic mean (standard deviation)
    13.6 ( 27.4 )
    No statistical analyses for this end point

    Secondary: QLQ-LC13: Chest pain

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    End point title
    		 QLQ-LC13: Chest pain
    End point description
    Final score minus baseline score
    End point type
    Secondary
    End point timeframe
    Every 3 weeks
    End point values
    		 Completed
    Number of subjects analysed
    73
    Units: Units
        arithmetic mean (standard error)
    -1.8 ( 29.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Received study intervention

    Serious adverse events
    		 Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    57 / 101 (56.44%)
         number of deaths (all causes)
    76
         number of deaths resulting from adverse events
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 101 (3.96%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Obstructive airways disorder
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    3 / 101 (2.97%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Radial head dislocation
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebellar syndrome
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune-mediated neurological disorder
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Multiple sclerosis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences causally related to treatment / all
    7 / 10
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal tubular disorder
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 101 (3.96%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Respiratory tract infection
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia
         subjects affected / exposed
    6 / 101 (5.94%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    1 / 1
    Herpes zoster reactivation
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    3 / 101 (2.97%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 101 (99.01%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    15 / 101 (14.85%)
         occurrences all number
    17
    Asthenia
         subjects affected / exposed
    64 / 101 (63.37%)
         occurrences all number
    157
    Mucosal inflammation
         subjects affected / exposed
    10 / 101 (9.90%)
         occurrences all number
    12
    Oedema peripheral
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences all number
    13
    Illness
         subjects affected / exposed
    6 / 101 (5.94%)
         occurrences all number
    8
    Fatigue
         subjects affected / exposed
    6 / 101 (5.94%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    23 / 101 (22.77%)
         occurrences all number
    28
    Dyspnoea
         subjects affected / exposed
    31 / 101 (30.69%)
         occurrences all number
    40
    Haemoptysis
         subjects affected / exposed
    7 / 101 (6.93%)
         occurrences all number
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences all number
    8
    Investigations
    Platelet count decreased
         subjects affected / exposed
    11 / 101 (10.89%)
         occurrences all number
    15
    Neutrophil count decreased
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences all number
    15
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 101 (6.93%)
         occurrences all number
    10
    Amylase increased
         subjects affected / exposed
    7 / 101 (6.93%)
         occurrences all number
    16
    Lymphocyte count decreased
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences all number
    13
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences all number
    11
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 101 (5.94%)
         occurrences all number
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences all number
    8
    Dysgeusia
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    34 / 101 (33.66%)
         occurrences all number
    56
    Anaemia
         subjects affected / exposed
    50 / 101 (49.50%)
         occurrences all number
    125
    Thrombocytopenia
         subjects affected / exposed
    19 / 101 (18.81%)
         occurrences all number
    27
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    21 / 101 (20.79%)
         occurrences all number
    25
    Constipation
         subjects affected / exposed
    27 / 101 (26.73%)
         occurrences all number
    35
    Nausea
         subjects affected / exposed
    18 / 101 (17.82%)
         occurrences all number
    22
    Vomiting
         subjects affected / exposed
    12 / 101 (11.88%)
         occurrences all number
    14
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    24 / 101 (23.76%)
         occurrences all number
    31
    Pruritus
         subjects affected / exposed
    12 / 101 (11.88%)
         occurrences all number
    13
    Rash
         subjects affected / exposed
    8 / 101 (7.92%)
         occurrences all number
    11
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    6 / 101 (5.94%)
         occurrences all number
    6
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    15 / 101 (14.85%)
         occurrences all number
    19
    Hyperthyroidism
         subjects affected / exposed
    7 / 101 (6.93%)
         occurrences all number
    8
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    16 / 101 (15.84%)
         occurrences all number
    19
    Arthralgia
         subjects affected / exposed
    14 / 101 (13.86%)
         occurrences all number
    23
    Pain in extremity
         subjects affected / exposed
    7 / 101 (6.93%)
         occurrences all number
    7
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    9 / 101 (8.91%)
         occurrences all number
    11
    Respiratory tract infection
         subjects affected / exposed
    10 / 101 (9.90%)
         occurrences all number
    12
    COVID-19
         subjects affected / exposed
    5 / 101 (4.95%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    18 / 101 (17.82%)
         occurrences all number
    19
    Hypomagnesaemia
         subjects affected / exposed
    10 / 101 (9.90%)
         occurrences all number
    12
    Hyperglycaemia
         subjects affected / exposed
    9 / 101 (8.91%)
         occurrences all number
    13
    Hyponatraemia
         subjects affected / exposed
    9 / 101 (8.91%)
         occurrences all number
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2021
    Addition of two biomarker substudies. Additional blood sampling at baseline and every 2 cycles until cycle 8 and a fresh tumor biopsy at disease progression. Updated inclusion criterion 4B in order to allow participation in the study of patients with brain metastases treated with steroids and anticonvulsants.

    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
    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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