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    Clinical Trial Results:
    A Phase II, Randomized, Blinded, Placebo-controlled Study of MTIG7192A, an Anti-tigit Antibody, in Combination With Atezolizumab in Chemotherapy-naive Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

    Summary
    EudraCT number
    		 2018-000280-81
    Trial protocol
    		 FR   ES   PL  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2020
    First version publication date
    05 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO40290
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03563716
    WHO universal trial number (UTN)
    		 -
    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
    30 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the efficacy of MTIG7192A plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 30
    Country: Number of subjects enrolled
    Serbia: 10
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    United States: 36
    Worldwide total number of subjects
    135
    EEA total number of subjects
    47
    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)
    56
    From 65 to 84 years
    79
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at study sites in 6 countries.

    Pre-assignment
    Screening details
    		 Eligible patients with previously untreated, locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC) were randomized 1:1 to receive either placebo plus atezolizumab or MTIG7192A plus atezolizumab.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Atezolizumab
    Arm description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Arm type
    		 Placebo

    Investigational medicinal product name
    atezolizumab
    Investigational medicinal product code
    Other name
    Tecentriq
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fixed dose of 1200 mg atezolizumab was administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo was administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Arm title
    		 MTIG7192A + Atezolizumab
    Arm description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    atezolizumab
    Investigational medicinal product code
    Other name
    Tecentriq
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fixed dose of 1200 mg atezolizumab was administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    MTIG7192A
    Investigational medicinal product code
    Other name
    tiragolumab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fixed dose of 600 mg MTIG7192A was administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Number of subjects in period 1
    		Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Started
    68
    67
    Completed
    0
    0
    Not completed
    68
    67
         Still on study
    45
    50
         Consent withdrawn by subject
    3
    3
         Death
    20
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Reporting group title
    MTIG7192A + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Reporting group values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab Total
    Number of subjects
    		 68 67 135
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.0 ± 9.9 65.8 ± 10.4 -
    Sex: Female, Male
    Units:
        Male
    		 48 39 87
        Female
    		 20 28 48

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Reporting group title
    MTIG7192A + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR, defined as a complete response (CR) or partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Intent-to-Treat (ITT) population included all participants randomized in the study.
    End point type
    Primary
    End point timeframe
    From baseline until a total of 80 progression free survival (PFS) events have occurred (up to approximately 11 months)
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    68
    67
    Units: percentage of participants
        number (confidence interval 95%)
    16.2 (6.69 to 25.66)
    31.3 (19.49 to 43.20)
    Statistical analysis title
    		 Placebo arm versus MTIG7192A arm
    Statistical analysis description
    Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.
    Comparison groups
    Placebo + Atezolizumab v MTIG7192A + Atezolizumab
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 6.14

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). ITT population included all participants randomized in the study. 9999=NE= not estimable
    End point type
    Primary
    End point timeframe
    From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    68
    67
    Units: months
        median (confidence interval 95%)
    3.58 (2.73 to 4.44)
    5.42 (4.21 to 9999)
    Statistical analysis title
    		 Placebo arm versus MTIG7192A arm
    Statistical analysis description
    Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.
    Comparison groups
    Placebo + Atezolizumab v MTIG7192A + Atezolizumab
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.9

    Secondary: Duration of Objective Response (DOR)

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    End point title
    		 Duration of Objective Response (DOR)
    End point description
    DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [1] - Data collection not complete; to be reported at time of Final Results.
    [2] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS, defined as the time from randomization to death from any cause.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [3] - Data collection not complete; to be reported at time of Final Results.
    [4] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Adverse Events

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    End point title
    		 Percentage of Participants With Adverse Events
    End point description
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: percentage of participants
        number (not applicable)
    Notes
    [5] - Data collection not complete; to be reported at time of Final Results.
    [6] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Secondary: Serum Concentrations of MTIG7192A

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    End point title
    		 Serum Concentrations of MTIG7192A
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: microgram/milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [7] - Data collection not complete; to be reported at time of Final Results.
    [8] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Atezolizumab

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    End point title
    		 Serum Concentrations of Atezolizumab
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: microgram/milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [9] - Data collection not complete; to be reported at time of Final Results.
    [10] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)

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    End point title
    		 Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
    End point values
    		 Placebo + Atezolizumab MTIG7192A + Atezolizumab
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: percentage of participants
        number (not applicable)
    Notes
    [11] - Data collection not complete; to be reported at time of Final Results.
    [12] - Data collection not complete; to be reported at time of Final Results.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to primary completion date (approximately 11 months)
    Adverse event reporting additional description
    The safety population included all participants who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    MTIG7192A + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Reporting group title
    Placebo + Atezolizumab
    Reporting group description
    		 Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Serious adverse events
    		 MTIG7192A + Atezolizumab Placebo + Atezolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 67 (34.33%)
    24 / 68 (35.29%)
         number of deaths (all causes)
    15
    20
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pericardial effusion malignant
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         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 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocarditis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Encephalopathy
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune nephritis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus colitis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural infection bacterial
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MTIG7192A + Atezolizumab Placebo + Atezolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 67 (89.55%)
    58 / 68 (85.29%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    17 / 67 (25.37%)
    17 / 68 (25.00%)
         occurrences all number
    19
    18
    Fatigue
         subjects affected / exposed
    15 / 67 (22.39%)
    9 / 68 (13.24%)
         occurrences all number
    18
    9
    Oedema peripheral
         subjects affected / exposed
    7 / 67 (10.45%)
    3 / 68 (4.41%)
         occurrences all number
    10
    3
    Pyrexia
         subjects affected / exposed
    8 / 67 (11.94%)
    9 / 68 (13.24%)
         occurrences all number
    9
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 67 (8.96%)
    7 / 68 (10.29%)
         occurrences all number
    6
    8
    Dyspnoea
         subjects affected / exposed
    9 / 67 (13.43%)
    13 / 68 (19.12%)
         occurrences all number
    10
    15
    Haemoptysis
         subjects affected / exposed
    5 / 67 (7.46%)
    5 / 68 (7.35%)
         occurrences all number
    6
    5
    Productive cough
         subjects affected / exposed
    3 / 67 (4.48%)
    7 / 68 (10.29%)
         occurrences all number
    3
    7
    Rhinorrhoea
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 68 (7.35%)
         occurrences all number
    4
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 68 (5.88%)
         occurrences all number
    6
    4
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 67 (4.48%)
    6 / 68 (8.82%)
         occurrences all number
    3
    6
    Amylase increased
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 68 (2.94%)
         occurrences all number
    9
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 67 (7.46%)
    5 / 68 (7.35%)
         occurrences all number
    5
    5
    Blood creatinine increased
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 68 (5.88%)
         occurrences all number
    2
    4
    Lipase increased
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 68 (2.94%)
         occurrences all number
    7
    2
    Weight decreased
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 68 (4.41%)
         occurrences all number
    4
    3
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    18 / 67 (26.87%)
    7 / 68 (10.29%)
         occurrences all number
    22
    17
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 67 (7.46%)
    2 / 68 (2.94%)
         occurrences all number
    5
    2
    Headache
         subjects affected / exposed
    4 / 67 (5.97%)
    5 / 68 (7.35%)
         occurrences all number
    5
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 67 (10.45%)
    4 / 68 (5.88%)
         occurrences all number
    7
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 68 (4.41%)
         occurrences all number
    5
    6
    Constipation
         subjects affected / exposed
    9 / 67 (13.43%)
    9 / 68 (13.24%)
         occurrences all number
    9
    9
    Diarrhoea
         subjects affected / exposed
    9 / 67 (13.43%)
    10 / 68 (14.71%)
         occurrences all number
    12
    11
    Nausea
         subjects affected / exposed
    4 / 67 (5.97%)
    7 / 68 (10.29%)
         occurrences all number
    4
    9
    Vomiting
         subjects affected / exposed
    4 / 67 (5.97%)
    6 / 68 (8.82%)
         occurrences all number
    5
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    13 / 67 (19.40%)
    8 / 68 (11.76%)
         occurrences all number
    13
    12
    Rash
         subjects affected / exposed
    13 / 67 (19.40%)
    6 / 68 (8.82%)
         occurrences all number
    14
    7
    Rash maculo-papular
         subjects affected / exposed
    6 / 67 (8.96%)
    1 / 68 (1.47%)
         occurrences all number
    8
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 68 (5.88%)
         occurrences all number
    4
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 67 (16.42%)
    6 / 68 (8.82%)
         occurrences all number
    14
    7
    Back pain
         subjects affected / exposed
    6 / 67 (8.96%)
    2 / 68 (2.94%)
         occurrences all number
    6
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 68 (5.88%)
         occurrences all number
    2
    4
    Musculoskeletal pain
         subjects affected / exposed
    4 / 67 (5.97%)
    6 / 68 (8.82%)
         occurrences all number
    4
    7
    Myalgia
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 68 (5.88%)
         occurrences all number
    3
    4
    Pain in extremity
         subjects affected / exposed
    5 / 67 (7.46%)
    2 / 68 (2.94%)
         occurrences all number
    5
    2
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 67 (2.99%)
    5 / 68 (7.35%)
         occurrences all number
    2
    7
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 68 (5.88%)
         occurrences all number
    5
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 67 (16.42%)
    12 / 68 (17.65%)
         occurrences all number
    11
    12
    Hypercalcaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 68 (5.88%)
         occurrences all number
    0
    4
    Hypokalaemia
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 68 (1.47%)
         occurrences all number
    6
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2018
    The following exclusion criteria were added: 1) Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC are excluded; 2) Patients with active Epstein-Barr virus (EBV) infection and patients with known or suspected chronic active EBV infection at screening are excluded. Lists of identified risks for atezolizumab and guidelines for managing participants, who experience atezolizumab-associated adverse events, were revised to include nephritis.
    06 Feb 2020
    The potential and identified risks for MTIG7192A and atezolizumab were updated to align with Investigator’s Brochures for MTIG7192A and atezolizumab. "Immune-related" was changed to "immune-mediated" when describing events associated with atezolizumab. References to the Immune-Modified Response Evaluation Criteria in Solid Tumors were removed. The timing of adverse event reporting was clarified. Systemic immune activation was replaced by hemophagocytic lymphohistiocytosis and macrophage activation syndrome in the list of potential risks for atezolizumab and the management guidelines for systemic immune activation were replaced with management guidelines for hemophagocytic lymphohistiocytosis and macrophage activation syndrome. In addition, systemic immune activation was removed from the list of adverse events of special interest.

    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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