Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

    Summary
    EudraCT number
    		 2013-001142-34
    Trial protocol
    		 BE   DE   HU   GB   ES   IT   SE   FR  
    Global end of trial date
    01 Dec 2015

    Results information
    Results version number
    		 v2
    This version publication date
    08 Jul 2017
    First version publication date
    22 May 2016
    Other versions
    		 v1 , v3
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GO28753
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01903993
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: POPLAR
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.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
    Interim
    Date of interim/final analysis
    07 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of atezolizumab compared with docetaxel in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or following a platinum-containing regimen.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the "Declaration of Helsinki" and Good Clinical Practice (GCP) according to the regulations and procedures described in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 Docetaxel is an approved standard 2nd line treatment with demonstrated survival benefit in Cancer.
    Actual start date of recruitment
    05 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Thailand: 15
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    United States: 132
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    287
    EEA total number of subjects
    112
    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)
    174
    From 65 to 84 years
    113
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 527 subjects were screened, of whom 287 subjects were randomised. 143 subjects to the docetaxel arm and 144 subjects to the atezolizumab arm. Overall, 10 subjects (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Docetaxel
    Arm description
    		 Subjects received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received starting dose of 75 mg/m^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Subjects randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice.

    Arm title
    		 Atezolizumab
    Arm description
    		 Subjects were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as subjects were experiencing clinical benefit as assessed by the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    MPDL3280A
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram [mg/kg]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Subject were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.

    Number of subjects in period 1
    		Docetaxel Atezolizumab
    Started
    143
    144
    Received Treatment
    135
    142
    Completed
    20
    49
    Not completed
    123
    95
         Consent withdrawn by subject
    13
    5
         Death
    108
    89
         Lost to follow-up
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Docetaxel
    Reporting group description
    		 Subjects received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Subjects were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as subjects were experiencing clinical benefit as assessed by the investigator.

    Reporting group values
    		 Docetaxel Atezolizumab Total
    Number of subjects
    		 143 144 287
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.8 ± 9.4 61.5 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 67 51 118
        Male
    		 76 93 169

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Docetaxel
    Reporting group description
    		 Subjects received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Subjects were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as subjects were experiencing clinical benefit as assessed by the investigator.

    Primary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    Overall Survival (OS) was defined as the time from the date of randomisation to the date of death due to any cause. Data for subjects who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive. Intent-to-treat (ITT) population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned.
    End point type
    Primary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    143
    144
    Units: months
        median (confidence interval 95%)
    9.7 (8.6 to 12)
    12.6 (9.7 to 16)
    Statistical analysis title
    		 Overall Survival
    Statistical analysis description
    Hazard ratios (HR) were estimated by a Cox regression model.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0106
    Method
    		 Log rank (stratified)
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.92

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned.
    End point type
    Secondary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    143
    144
    Units: months
        median (confidence interval 95%)
    3.4 (2.8 to 4.1)
    2.7 (2 to 4.1)
    Statistical analysis title
    		 Progression free survival
    Statistical analysis description
    HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5563
    Method
    		 Log rank (stratified)
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.2

    Secondary: Objective Response Rate (ORR)

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR was defined as the percentage of subjects with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned.
    End point type
    Secondary
    End point timeframe
    Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    143
    144
    Units: percentage of subjects
        number (confidence interval 95%)
    15.3 (9.83 to 22.21)
    14.7 (9.33 to 21.57)
    Statistical analysis title
    		 Objective response rate
    Comparison groups
    Atezolizumab v Docetaxel
    Number of subjects included in analysis
    287
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8884
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.67
         upper limit
    		 8.85

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the duration from the first tumor assessment that supports the subject’s objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned. Here, 99999 indicates upper limit of confidence interval (CI) for Atezolizumab arm as the CI was not estimable.
    End point type
    Secondary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
    End point values
    		 Docetaxel Atezolizumab
    Number of subjects analysed
    21 [1]
    22 [2]
    Units: months
        median (confidence interval 95%)
    7.2 (5.6 to 12.5)
    18.6 (11.6 to 99999)
    Notes
    [1] - Number of subjects who were evaluable for this endpoint.
    [2] - Number of subjects who were evaluable for this endpoint.
    Statistical analysis title
    		 Duration of response
    Statistical analysis description
    HR were estimated by a unstratified Cox regression model.
    Comparison groups
    Docetaxel v Atezolizumab
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0028
    Method
    		 Log rank (unstratified)
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.7

    Secondary: ORR (Modified RECIST)

    		 Close Top of page
    End point title
    		 ORR (Modified RECIST) [3]
    End point description
    ORR was defined as the percentage of subjects with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned.
    End point type
    Secondary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off: 08 May 2015 (up to 21 months)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Atezolizumab
    Number of subjects analysed
    144
    Units: percentage of subjects
        number (confidence interval 95%)
    16.7 (10.98 to 23.78)
    No statistical analyses for this end point

    Secondary: PFS (Modified RECIST)

    		 Close Top of page
    End point title
    		 PFS (Modified RECIST) [4]
    End point description
    PFS was defined as the time (in months) between the date of randomisation and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned.
    End point type
    Secondary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off: 08 May 2015 (up to 21 months)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Atezolizumab
    Number of subjects analysed
    144
    Units: months
        median (confidence interval 95%)
    4.2 (3.9 to 6.9)
    No statistical analyses for this end point

    Secondary: DOR (Modified RECIST)

    		 Close Top of page
    End point title
    		 DOR (Modified RECIST) [5]
    End point description
    DOR was defined as the duration from the first tumor assessment that supports the subject’s objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. ITT population for efficacy analyses included all randomised subjects, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, subjects were grouped according to the treatment arm to which they were assigned. Here, 99999 indicates upper limit of confidence interval (CI) for Atezolizumab arm as the CI was not estimable.
    End point type
    Secondary
    End point timeframe
    From the time of randomisation to the date of death due to any cause or up to data cut off: 08 May 2015 (up to 21 months)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 Atezolizumab
    Number of subjects analysed
    24 [6]
    Units: months
        median (confidence interval 95%)
    14.9 (11.6 to 99999)
    Notes
    [6] - Number of subjects who were evaluable for this endpoint.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the first study drug to the data cutoff date: 01 Dec 2015 (up to 28 months)
    Adverse event reporting additional description
    Treatment−emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non−protocol anti−cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Docetaxel
    Reporting group description
    		 Subjects received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Subjects were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as subjects were experiencing clinical benefit as assessed by the investigator.

    Serious adverse events
    		 Docetaxel Atezolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 135 (34.07%)
    50 / 142 (35.21%)
         number of deaths (all causes)
    5
    6
         number of deaths resulting from adverse events
    3
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral embolism
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous stenosis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 135 (1.48%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Device dislocation
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 142 (2.11%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 135 (1.48%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 135 (0.74%)
    6 / 142 (4.23%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 135 (2.22%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 135 (0.00%)
    4 / 142 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    6 / 135 (4.44%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radiation pneumonitis
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac tamponade
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    7 / 135 (5.19%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 135 (1.48%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 135 (2.22%)
    10 / 142 (7.04%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 135 (2.22%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Docetaxel Atezolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    124 / 135 (91.85%)
    126 / 142 (88.73%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    4 / 135 (2.96%)
    9 / 142 (6.34%)
         occurrences all number
    4
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    21 / 135 (15.56%)
    15 / 142 (10.56%)
         occurrences all number
    27
    25
    Chest pain
         subjects affected / exposed
    6 / 135 (4.44%)
    10 / 142 (7.04%)
         occurrences all number
    8
    11
    Fatigue
         subjects affected / exposed
    53 / 135 (39.26%)
    55 / 142 (38.73%)
         occurrences all number
    85
    78
    Oedema peripheral
         subjects affected / exposed
    13 / 135 (9.63%)
    9 / 142 (6.34%)
         occurrences all number
    18
    11
    Pain
         subjects affected / exposed
    10 / 135 (7.41%)
    5 / 142 (3.52%)
         occurrences all number
    11
    6
    Pyrexia
         subjects affected / exposed
    15 / 135 (11.11%)
    22 / 142 (15.49%)
         occurrences all number
    18
    27
    Influenza like illness
         subjects affected / exposed
    2 / 135 (1.48%)
    8 / 142 (5.63%)
         occurrences all number
    2
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    33 / 135 (24.44%)
    40 / 142 (28.17%)
         occurrences all number
    40
    49
    Dyspnoea
         subjects affected / exposed
    27 / 135 (20.00%)
    34 / 142 (23.94%)
         occurrences all number
    32
    38
    Dyspnoea exertional
         subjects affected / exposed
    3 / 135 (2.22%)
    10 / 142 (7.04%)
         occurrences all number
    3
    10
    Haemoptysis
         subjects affected / exposed
    6 / 135 (4.44%)
    14 / 142 (9.86%)
         occurrences all number
    10
    19
    Productive cough
         subjects affected / exposed
    2 / 135 (1.48%)
    8 / 142 (5.63%)
         occurrences all number
    2
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    11 / 135 (8.15%)
    22 / 142 (15.49%)
         occurrences all number
    12
    23
    Investigations
    Weight decreased
         subjects affected / exposed
    9 / 135 (6.67%)
    16 / 142 (11.27%)
         occurrences all number
    9
    20
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 135 (8.15%)
    10 / 142 (7.04%)
         occurrences all number
    12
    15
    Dysgeusia
         subjects affected / exposed
    7 / 135 (5.19%)
    1 / 142 (0.70%)
         occurrences all number
    8
    1
    Headache
         subjects affected / exposed
    10 / 135 (7.41%)
    14 / 142 (9.86%)
         occurrences all number
    10
    17
    Neuropathy peripheral
         subjects affected / exposed
    16 / 135 (11.85%)
    3 / 142 (2.11%)
         occurrences all number
    20
    5
    Peripheral sensory neuropathy
         subjects affected / exposed
    12 / 135 (8.89%)
    1 / 142 (0.70%)
         occurrences all number
    21
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    26 / 135 (19.26%)
    25 / 142 (17.61%)
         occurrences all number
    37
    42
    Neutropenia
         subjects affected / exposed
    15 / 135 (11.11%)
    2 / 142 (1.41%)
         occurrences all number
    23
    2
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    7 / 135 (5.19%)
    1 / 142 (0.70%)
         occurrences all number
    9
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    31 / 135 (22.96%)
    31 / 142 (21.83%)
         occurrences all number
    33
    32
    Diarrhoea
         subjects affected / exposed
    37 / 135 (27.41%)
    24 / 142 (16.90%)
         occurrences all number
    50
    32
    Dyspepsia
         subjects affected / exposed
    7 / 135 (5.19%)
    3 / 142 (2.11%)
         occurrences all number
    7
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 135 (5.19%)
    8 / 142 (5.63%)
         occurrences all number
    8
    9
    Nausea
         subjects affected / exposed
    45 / 135 (33.33%)
    31 / 142 (21.83%)
         occurrences all number
    63
    40
    Stomatitis
         subjects affected / exposed
    9 / 135 (6.67%)
    3 / 142 (2.11%)
         occurrences all number
    9
    3
    Vomiting
         subjects affected / exposed
    18 / 135 (13.33%)
    20 / 142 (14.08%)
         occurrences all number
    20
    25
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    52 / 135 (38.52%)
    3 / 142 (2.11%)
         occurrences all number
    57
    3
    Dry skin
         subjects affected / exposed
    10 / 135 (7.41%)
    3 / 142 (2.11%)
         occurrences all number
    10
    3
    Nail disorder
         subjects affected / exposed
    9 / 135 (6.67%)
    1 / 142 (0.70%)
         occurrences all number
    9
    1
    Pruritus
         subjects affected / exposed
    5 / 135 (3.70%)
    13 / 142 (9.15%)
         occurrences all number
    5
    21
    Rash
         subjects affected / exposed
    16 / 135 (11.85%)
    15 / 142 (10.56%)
         occurrences all number
    19
    27
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 135 (0.00%)
    9 / 142 (6.34%)
         occurrences all number
    0
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 135 (8.89%)
    22 / 142 (15.49%)
         occurrences all number
    16
    26
    Back pain
         subjects affected / exposed
    10 / 135 (7.41%)
    16 / 142 (11.27%)
         occurrences all number
    11
    17
    Musculoskeletal chest pain
         subjects affected / exposed
    4 / 135 (2.96%)
    9 / 142 (6.34%)
         occurrences all number
    5
    10
    Musculoskeletal pain
         subjects affected / exposed
    7 / 135 (5.19%)
    19 / 142 (13.38%)
         occurrences all number
    7
    19
    Myalgia
         subjects affected / exposed
    18 / 135 (13.33%)
    8 / 142 (5.63%)
         occurrences all number
    24
    9
    Pain in extremity
         subjects affected / exposed
    13 / 135 (9.63%)
    9 / 142 (6.34%)
         occurrences all number
    18
    11
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 135 (2.22%)
    10 / 142 (7.04%)
         occurrences all number
    5
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    28 / 135 (20.74%)
    49 / 142 (34.51%)
         occurrences all number
    35
    59
    Dehydration
         subjects affected / exposed
    11 / 135 (8.15%)
    5 / 142 (3.52%)
         occurrences all number
    11
    7
    Hypokalaemia
         subjects affected / exposed
    4 / 135 (2.96%)
    9 / 142 (6.34%)
         occurrences all number
    4
    12
    Hyponatraemia
         subjects affected / exposed
    4 / 135 (2.96%)
    8 / 142 (5.63%)
         occurrences all number
    4
    12
    Hypomagnesaemia
         subjects affected / exposed
    5 / 135 (3.70%)
    8 / 142 (5.63%)
         occurrences all number
    6
    10

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jul 2013
    1. Inclusion Criteria: a) The window for prior treatment with immunostimulatory agents has been adjusted to be consistent with the exclusion criterion covering this prior therapy b) The criterion for liver function test results has been modified to be consistent with the docetaxel US Package Insert c) The formula for estimated glomerular filtration rate has been corrected with regard to numbers and variables that should be superscripted 2.Exclusion Criteria: a) Exclusion for subjects with known or untreated central nervous system (CNS) metastases clarified to indicate that subjects must not have active or untreated CNS metastases as determined by computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Additionally, subjects must not have had stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1, Day 1 b) Exclusion added for known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the MPDL3280A formulation as a safety precaution c) Exclusion added for subjects with prior allogeneic bone marrow transplantation or prior solid organ transplantation as a safety precaution d) Exclusion added for subjects having a positive Human immunodeficiency virus (HIV) test as a safety precaution e) Exclusion criterion for subjects with active hepatitis B clarified with respect to definitive serology results f) Exclusion criteria for subjects with active hepatitis C broken out into its own criterion for clarity
    30 Jan 2014
    Study design, determination of sample size, and administrative structure were revised to reflect the continuation of enrollment of subjects until a minimum of approximately 54 subjects Programmed death - ligand 1 (PD-L1) −positive.
    20 May 2014
    1. Treatment duration for atezolizumab was modified to allow subjects to be treated until clinical benefit was no longer being experienced; accordingly, the 16-cycle or 12-month initial treatment, follow-up, and re-treatment periods no longer applied. 2. The frequency of tumor assessments after 36 weeks changed from every 12 weeks to every 9 weeks (± 1 week) to be more consistent with clinical practice in non−small cell lung cancer. 3. The timing of the interim safety and efficacy data evaluation by the Internal Monitoring Committee changed from when 30 and 60 deaths were observed to when approximately 30 and 100 deaths had occurred. The change to evaluate at 100 deaths was determined to be more appropriate than 60 with regard to estimating efficacy in both the PD-L1 IC2/IC3 and overall study populations. 4. The terms “PD-L1 positive” and “PD-L1 negative” were replaced with “PD-L1 (Tumor-infiltrating immune cell 2/Tumor-infiltrating immune cell 3 (IC2/IC3)” and “PD-L1 IC0/IC1,” respectively, to clarify that these categorizations did not necessarily reflect a final definition of positivity for PD-L1 expression using this diagnostic assay. 5. The AE/safety follow-up period changed from 90 to 30 days in order to harmonize safety data collection across the atezolizumab clinical development program. The follow-up period was shortened because of the low frequency of significant drugrelated AEs following treatment discontinuation across studies. 6. Statistical considerations and the analysis plan were changed to reflect the increase in study size that was put into place in Version 3 of this protocol.
    24 Jul 2014
    The safety follow-up period was changed back to the original 90 days to maintain a consistent follow-up period throughout the study and to allow further evaluation of safety after treatment discontinuation in this Phase II trial.
    24 Feb 2015
    1. Adjusted the event threshold for the primary analysis to approximately 180 death events and converted the originally planned analysis at approximately 150 death events to an interim analysis. This change was made in order to allow for an improved evaluation of late events in the survival curves of atezolizumab compared with docetaxel. 2. Clarified that stratification by PD-L1 immunohistochemistry (IHC) status was based on PD-L1 expression on tumor-infiltrating immune cells. 3. In addition to the primary analyses on the ITT population and the subgroup of subjects with PD-L1 IHC 2 or IHC 3 expression status in ICs, the protocol was amended to allow for subgroup analyses based on other categories of PD-L1 expression (e.g., including expression on tumor cells [TCs]).

    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.

    European Medicines Agency © 1995-Mon Apr 29 05:01:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA