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    Clinical Trial Results:
    A Phase II, Open-label, Multicentre, International Study of Durvalumab Following Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy (DUART)

    Summary
    EudraCT number
    		 2019-004336-31
    Trial protocol
    		 FR   PL   IT  
    Global end of trial date
    25 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2025
    First version publication date
    02 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D4194C00009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04249362
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, 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
    06 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 possibly related adverse events (PRAEs) within 6 months from the initiation of durvalumab treatment.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics. The Investigator or his/her representative explained the nature of the study to the subject or his/her legally authorised representative and answered all questions regarding the study. Subjects were informed that their participation was voluntary. Subjects or their legally authorised representative were required to sign a statement of informed consent that met the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) or study centre.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 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
    France: 11
    Country: Number of subjects enrolled
    Italy: 47
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Spain: 9
    Worldwide total number of subjects
    102
    EEA total number of subjects
    97
    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)
    8
    From 65 to 84 years
    84
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled and received study treatment at 29 sites in 5 countries (France, Italy, Poland, Russian Federation, and Spain). The data in this report are based on study start date (first patient enrolled: 26 November 2020 till final analyses data cut-off date of 06 December 2023.

    Pre-assignment
    Screening details
    		 Eligible patients with Stage III unresectable Non-Small Cell Lung Cancer (NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2, treated with radiotherapy and ineligible for chemotherapy, were enrolled. One patient had an important protocol deviation. Study assessments followed the schedule.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Durvalumab Cohort A: Standard radiotherapy (RT)
    Arm description
    		 Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w)

    Arm title
    		 Durvaumab Cohort B: Palliative radiotherapy (RT)
    Arm description
    		 Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w)

    Number of subjects in period 1
    		Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT)
    Started
    53
    49
    Completed
    53
    49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Durvalumab Cohort A: Standard radiotherapy (RT)
    Reporting group description
    		 Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Reporting group title
    Durvaumab Cohort B: Palliative radiotherapy (RT)
    Reporting group description
    		 Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Reporting group values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Total
    Number of subjects
    		 53 49 102
    Age categorical
    Units: Patients
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 2 8
        From 65-84 years
    		 44 40 84
        85 years and over
    		 3 7 10
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 74.7 ( 9.18 ) 78.8 ( 6.71 ) -
    Sex: Female, Male
    Units: Patients
        Female
    		 15 14 29
        Male
    		 38 35 73
    Race, Customized
    Units: Subjects
        White
    		 46 45 91
        Other
    		 1 0 1
        Unknown
    		 3 1 4
        Missing
    		 3 3 6
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 45 43 88
        Missing
    		 6 3 9
    Subject analysis sets

    Subject analysis set title
    Durvalumab total
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Subject analysis set title
    Durvalumab responders
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. This group includes patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria.

    Subject analysis sets values
    		 Durvalumab total Durvalumab responders
    Number of subjects
    102
    30
    Age categorical
    Units: Patients
        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)
    8
        From 65-84 years
    84
        85 years and over
    10
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    76.7 ( 8.32 )
    ( )
    Sex: Female, Male
    Units: Patients
        Female
    29
        Male
    73
    Race, Customized
    Units: Subjects
        White
    91
        Other
    1
        Unknown
    4
        Missing
    6
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    5
        Not Hispanic or Latino
    88
        Missing
    9

    End points

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    End points reporting groups
    Reporting group title
    Durvalumab Cohort A: Standard radiotherapy (RT)
    Reporting group description
    		 Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Reporting group title
    Durvaumab Cohort B: Palliative radiotherapy (RT)
    Reporting group description
    		 Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Subject analysis set title
    Durvalumab total
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Subject analysis set title
    Durvalumab responders
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. This group includes patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria.

    Primary: Number of patients with Grade 3 and Grade 4 possibly-related adverse events (PRAEs)

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    End point title
    		 Number of patients with Grade 3 and Grade 4 possibly-related adverse events (PRAEs) [1]
    End point description
    The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Primary
    End point timeframe
    From first dose of durvalumab treatment until 6 months after initiation of durvalumab 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: No statistical analysis was performed.
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Patients
    5
    5
    10
    No statistical analyses for this end point

    Secondary: Median Progression-free survival (mPFS)

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    End point title
    		 Median Progression-free survival (mPFS)
    End point description
    Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Months
        median (confidence interval 95%)
    10.3 (7.49 to 16.56)
    7.6 (5.55 to 11.04)
    9.2 (7.39 to 11.93)
    No statistical analyses for this end point

    Secondary: Progression-free survival at 6 months (PFS6)

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    End point title
    		 Progression-free survival at 6 months (PFS6)
    End point description
    Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From the first date of treatment until the date of objective disease progression or death (6 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Percentage of patients
        number (confidence interval 95%)
    67.1 (51.96 to 78.43)
    59.3 (43.38 to 72.07)
    63.3 (52.62 to 72.25)
    No statistical analyses for this end point

    Secondary: Progression-free survival at 12 months (PFS12)

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    End point title
    		 Progression-free survival at 12 months (PFS12)
    End point description
    Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From the first date of treatment until the date of objective disease progression or death (12 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Percentage of patients
        number (confidence interval 95%)
    46.8 (31.88 to 60.36)
    31.8 (18.13 to 46.32)
    39.6 (29.28 to 49.76)
    No statistical analyses for this end point

    Secondary: Median overall survival (mOS)

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    End point title
    		 Median overall survival (mOS)
    End point description
    The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. Here, arbitrary value 9999.9999 represents data that were not calculable due to insufficient number of patients with events. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From the first date of treatment until death or data cut-off due to any cause (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Months
        median (confidence interval 95%)
    21.1 (11.60 to 9999.9999)
    16.8 (10.64 to 9999.9999)
    21.1 (14.75 to 9999.9999)
    No statistical analyses for this end point

    Secondary: Overall survival at 12 months (OS12)

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    End point title
    		 Overall survival at 12 months (OS12)
    End point description
    The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From the first date of treatment until death due to any cause (12 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Percentage of patients
        number (confidence interval 95%)
    64.0 (49.01 to 75.58)
    65.5 (49.87 to 77.26)
    64.7 (54.21 to 73.34)
    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
    The ORR is the proportion (%) of patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria. CR is disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Percentage of patients
        number (confidence interval 95%)
    34.0 (21.5 to 48.3)
    24.5 (13.3 to 38.9)
    29.4 (20.8 to 39.3)
    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
    The DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. The arbitary value 9999.9999 represents data that data were not calculable due to insufficient number of patients with events. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab responders
    Number of subjects analysed
    18
    12
    30
    Units: Weeks
        median (confidence interval 95%)
    56.9 (31.00 to 9999.9999)
    34.1 (24.29 to 9999.9999)
    56.9 (31.14 to 9999.9999)
    No statistical analyses for this end point

    Secondary: Lung cancer mortality

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    End point title
    		 Lung cancer mortality
    End point description
    The lung cancer mortality (NSCLC-related death) is assessed using the deaths which are reported as ‘NSCLC-related’ and is defined as the time (days) from the date of first dose of durvalumab until date of death due to lung cancer. The arbitary value 9999.9999 represents data that data were not calculable due to insufficient number of patients with events. The endpoint included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment.
    End point type
    Secondary
    End point timeframe
    From date of treatment start until death due to lung cancer (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Months
        median (confidence interval 95%)
    30.9 (16.92 to 9999.9999)
    9999.9999 (14.75 to 9999.9999)
    30.9 (16.82 to 9999.9999)
    No statistical analyses for this end point

    Secondary: Number of patients with events (AEs)

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    End point title
    		 Number of patients with events (AEs)
    End point description
    The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment. Common Terminology Criteria for Adverse Events-CTCAE; possibly related to durvalumab treatment-PRTT; discontinuation of treatment- DT; treatment interruption- TI; including- incl. and adverse event of potential interest-AEPI.
    End point type
    Secondary
    End point timeframe
    From screening (Day -28) till data cut-off (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Patients
        Any AE
    50
    49
    99
        Any PRAE (Investigator-assessed [IA])
    31
    31
    62
        Any AE of CTCAE Grade (Gr) 3 or Gr 4
    20
    21
    41
        Any AE of CTCAE Gr 3 or Gr 4, PRTT (IA)
    6
    5
    11
        Any AE resulted in death
    5
    2
    7
        Any AE resulted death, PRTT (IA)
    1
    0
    1
        Any SAE incl. events resulted in death
    23
    18
    41
        Any SAE incl. events resulted in death, PRTT (IA)
    5
    3
    8
        Any AE leading to DT
    13
    9
    22
        Any AE leading to DT, PRTT (IA)
    7
    5
    12
        Any AE leading to TI
    25
    23
    48
        Any AE leading to TI, PRTT
    6
    7
    13
        Any AESI incl. events resulted in death (IA)
    25
    21
    46
        Any AESI incl. events resulted in death, PRTT (IA)
    19
    14
    33
        Any AEPI incl. events resulted in death (IA)
    21
    22
    43
        Any AEPI incl. events resulted in death, PRTT (IA)
    14
    15
    29
        Any imAE (IA)
    27
    24
    51
        Any imAE, PRTT (IA)
    26
    24
    50
    No statistical analyses for this end point

    Secondary: Number of patients with adverse events of special interests (AESIs)

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    End point title
    		 Number of patients with adverse events of special interests (AESIs)
    End point description
    The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An AESI is an AE of scientific and medical interest specific to the understanding of durvalumab. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Here, number of patients experienced AESIs are presented. Serious adverse event of special interests (SAESIs). The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment. Common Terminology Criteria for Adverse Events-CTCAE; discontinuation of treatment- DT; including- incl. and causally related to treatment- CRT.
    End point type
    Secondary
    End point timeframe
    From screening (Day -28) till data cut-off (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Patients
        Any AESIs
    25
    21
    46
        Any AESIs of CTCAE Gr 3 or 4
    4
    1
    5
        Any SAESIs incl. events resulted in death
    4
    1
    5
        Any AESIs resulted in death
    1
    0
    1
        Any AESIs, CRT
    19
    14
    33
        Any AESIs of CTCAE Gr 3 or 4, CRT
    4
    1
    5
        Any SAESIs, CRT
    4
    1
    5
        Any AESIs resulted in death, CRT
    1
    0
    1
        AESIs: Received systemic corticosteroids
    5
    8
    13
        AESIs: Received high dose steroids
    4
    6
    10
        AESIs: Received endocrine therapy
    6
    5
    11
        AESIs: Received other immunosuppressants
    0
    0
    0
        Any AESIs leading to DT
    4
    3
    7
        AESIs: Event outcome resolved
    13
    12
    25
        AESIs: Event outcome not resolved
    11
    9
    20
    No statistical analyses for this end point

    Secondary: Number of patients with immune-mediated adverse events (imAEs)

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    End point title
    		 Number of patients with immune-mediated adverse events (imAEs)
    End point description
    The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate etiology. Here, number of patients experienced imAEs are presented. Immune-mediated serious adverse events (imSAEs). The end point included safety analysis set, consisted of all patients who received at least one dose of durvalumab treatment. Common Terminology Criteria for Adverse Events-CTCAE; discontinuation of treatment- DT; including- incl. and causally related to treatment- CRT.
    End point type
    Secondary
    End point timeframe
    From screening (Day -28) till data cut-off (36 months)
    End point values
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvaumab Cohort B: Palliative radiotherapy (RT) Durvalumab total
    Number of subjects analysed
    53
    49
    102
    Units: Patients
        Any imAEs
    11
    15
    26
        Any imAEs of CTCAE Gr 3 or 4
    2
    3
    5
        Any imSAEs incl. events resulted in death
    3
    2
    5
        Any imAEs resulted in death
    1
    0
    1
        Any imAEs, CRT
    10
    12
    22
        Any imAEs of CTCAE Gr 3 or 4, CRT
    2
    3
    5
        Any imSAEs, CRT
    3
    2
    5
        Any imAEs resulted in death, CRT
    1
    0
    1
        imAEs: Received systemic corticosteroids
    7
    13
    20
        imAEs: Received high dose steroids
    5
    7
    12
        imAEs: Received endocrine therapy
    6
    5
    11
        imAEs: Received other immunosuppressants
    0
    0
    0
        Any imAEs leading to DT
    3
    4
    7
        imAEs: Event outcome resolved
    5
    8
    13
        imAEs: Event outcome not resolved
    5
    7
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening (Day -28) till data cut-off (36 months)
    Adverse event reporting additional description
    Frequency threshold for reporting non-serious adverse events is 2.5. However, due to tool limitation in the below field 2 has been entered.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Durvalumab Cohort A: Standard radiotherapy (RT)
    Reporting group description
    		 Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Reporting group title
    Durvalumab total
    Reporting group description
    		 Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Reporting group title
    Durvaumab Cohort B: Palliative radiotherapy (RT)
    Reporting group description
    		 Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

    Serious adverse events
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvalumab total Durvaumab Cohort B: Palliative radiotherapy (RT)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 53 (43.40%)
    41 / 102 (40.20%)
    18 / 49 (36.73%)
         number of deaths (all causes)
    23
    46
    23
         number of deaths resulting from adverse events
    5
    7
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 102 (1.96%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Asthenia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 102 (1.96%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 102 (1.96%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haemorrhage
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 102 (4.90%)
    4 / 49 (8.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatomyositis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Immune-mediated nephritis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 102 (0.98%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 102 (4.90%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 102 (0.98%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Durvalumab Cohort A: Standard radiotherapy (RT) Durvalumab total Durvaumab Cohort B: Palliative radiotherapy (RT)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 53 (88.68%)
    92 / 102 (90.20%)
    45 / 49 (91.84%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 102 (4.90%)
    5 / 49 (10.20%)
         occurrences all number
    0
    5
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    13 / 53 (24.53%)
    21 / 102 (20.59%)
    8 / 49 (16.33%)
         occurrences all number
    14
    23
    9
    Fatigue
         subjects affected / exposed
    1 / 53 (1.89%)
    11 / 102 (10.78%)
    10 / 49 (20.41%)
         occurrences all number
    1
    11
    10
    Oedema peripheral
         subjects affected / exposed
    3 / 53 (5.66%)
    8 / 102 (7.84%)
    5 / 49 (10.20%)
         occurrences all number
    3
    8
    5
    Pyrexia
         subjects affected / exposed
    8 / 53 (15.09%)
    16 / 102 (15.69%)
    8 / 49 (16.33%)
         occurrences all number
    9
    18
    9
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    3 / 53 (5.66%)
    6 / 102 (5.88%)
    3 / 49 (6.12%)
         occurrences all number
    3
    6
    3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 53 (3.77%)
    6 / 102 (5.88%)
    4 / 49 (8.16%)
         occurrences all number
    2
    6
    4
    Cough
         subjects affected / exposed
    9 / 53 (16.98%)
    21 / 102 (20.59%)
    12 / 49 (24.49%)
         occurrences all number
    13
    26
    13
    Dyspnoea
         subjects affected / exposed
    11 / 53 (20.75%)
    19 / 102 (18.63%)
    8 / 49 (16.33%)
         occurrences all number
    11
    19
    8
    Haemoptysis
         subjects affected / exposed
    2 / 53 (3.77%)
    5 / 102 (4.90%)
    3 / 49 (6.12%)
         occurrences all number
    2
    5
    3
    Pneumonitis
         subjects affected / exposed
    3 / 53 (5.66%)
    7 / 102 (6.86%)
    4 / 49 (8.16%)
         occurrences all number
    3
    7
    4
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Respiratory failure
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Investigations
    Weight decreased
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Neutrophil count increased
         subjects affected / exposed
    4 / 53 (7.55%)
    4 / 102 (3.92%)
    0 / 49 (0.00%)
         occurrences all number
    6
    6
    0
    Lipase increased
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    2
    4
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 53 (7.55%)
    7 / 102 (6.86%)
    3 / 49 (6.12%)
         occurrences all number
    4
    7
    3
    Amylase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 102 (4.90%)
    2 / 49 (4.08%)
         occurrences all number
    3
    7
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 102 (3.92%)
    1 / 49 (2.04%)
         occurrences all number
    4
    5
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 102 (4.90%)
    2 / 49 (4.08%)
         occurrences all number
    3
    6
    3
    Blood creatinine increased
         subjects affected / exposed
    2 / 53 (3.77%)
    6 / 102 (5.88%)
    4 / 49 (8.16%)
         occurrences all number
    2
    8
    6
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 102 (3.92%)
    1 / 49 (2.04%)
         occurrences all number
    3
    4
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    3
    3
    0
    Blood urea increased
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 102 (3.92%)
    1 / 49 (2.04%)
         occurrences all number
    5
    6
    1
    Blood uric acid increased
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 102 (2.94%)
    1 / 49 (2.04%)
         occurrences all number
    2
    3
    1
    C-reactive protein increased
         subjects affected / exposed
    4 / 53 (7.55%)
    5 / 102 (4.90%)
    1 / 49 (2.04%)
         occurrences all number
    4
    5
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 102 (4.90%)
    2 / 49 (4.08%)
         occurrences all number
    3
    5
    2
    Injury, poisoning and procedural complications
    Radiation pneumonitis
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Spinal compression fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Fall
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 102 (2.94%)
    1 / 49 (2.04%)
         occurrences all number
    2
    3
    1
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    3
    3
    0
    Thrombocytosis
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Lymphopenia
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 102 (3.92%)
    2 / 49 (4.08%)
         occurrences all number
    2
    4
    2
    Leukocytosis
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 102 (4.90%)
    2 / 49 (4.08%)
         occurrences all number
    3
    5
    2
    Anaemia
         subjects affected / exposed
    13 / 53 (24.53%)
    19 / 102 (18.63%)
    6 / 49 (12.24%)
         occurrences all number
    14
    22
    8
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Constipation
         subjects affected / exposed
    3 / 53 (5.66%)
    13 / 102 (12.75%)
    10 / 49 (20.41%)
         occurrences all number
    3
    15
    12
    Diarrhoea
         subjects affected / exposed
    3 / 53 (5.66%)
    7 / 102 (6.86%)
    4 / 49 (8.16%)
         occurrences all number
    3
    8
    5
    Nausea
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 102 (3.92%)
    4 / 49 (8.16%)
         occurrences all number
    0
    4
    4
    Stomatitis
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Erythema
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Pruritus
         subjects affected / exposed
    5 / 53 (9.43%)
    13 / 102 (12.75%)
    8 / 49 (16.33%)
         occurrences all number
    5
    14
    9
    Rash
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 102 (2.94%)
    1 / 49 (2.04%)
         occurrences all number
    2
    3
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 102 (2.94%)
    1 / 49 (2.04%)
         occurrences all number
    2
    3
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    6 / 53 (11.32%)
    11 / 102 (10.78%)
    5 / 49 (10.20%)
         occurrences all number
    6
    11
    5
    Hypothyroidism
         subjects affected / exposed
    9 / 53 (16.98%)
    15 / 102 (14.71%)
    6 / 49 (12.24%)
         occurrences all number
    9
    17
    8
    Thyroiditis
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 53 (15.09%)
    14 / 102 (13.73%)
    6 / 49 (12.24%)
         occurrences all number
    10
    16
    6
    Back pain
         subjects affected / exposed
    5 / 53 (9.43%)
    10 / 102 (9.80%)
    5 / 49 (10.20%)
         occurrences all number
    5
    11
    6
    Musculoskeletal pain
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Neck pain
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Pain in extremity
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 102 (2.94%)
    2 / 49 (4.08%)
         occurrences all number
    1
    3
    2
    Spinal pain
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 102 (1.96%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 53 (5.66%)
    6 / 102 (5.88%)
    3 / 49 (6.12%)
         occurrences all number
    3
    7
    4
    Herpes zoster
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 102 (1.96%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    COVID-19
         subjects affected / exposed
    6 / 53 (11.32%)
    9 / 102 (8.82%)
    3 / 49 (6.12%)
         occurrences all number
    6
    9
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 53 (15.09%)
    14 / 102 (13.73%)
    6 / 49 (12.24%)
         occurrences all number
    8
    15
    7
    Hyperkalaemia
         subjects affected / exposed
    2 / 53 (3.77%)
    6 / 102 (5.88%)
    4 / 49 (8.16%)
         occurrences all number
    2
    9
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Aug 2023
    Amendment 1: Section 4.1, Table 2, Section 7.1.1, Section 7.1.2: the minimum expected safety follow-up period of 90 days following the last dose of durvalumab for patients treated with the study treatment has been detailed and clarified, and accordingly new sections (Section 7.1.1 and 7.1.2) were added. Section 4.4 and Section 6.1.3: a new section as “Continued access to study treatment” was added. Section 9.5: details related to data analysis (DCO for the primary analysis) were added. Section 6: updated the definition for “study treatments” and details of durvalumab in Table 5. Also updated text describing administration of study treatment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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