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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled phase III trial of tecemotide versus placebo in subjects with completed concurrent chemo-radiotherapy for unresectable stage III non-small cell lung cancer (NSCLC)

    Summary
    EudraCT number
    2013-003760-30
    Trial protocol
    CZ   AT   BE   DE   SE   PT   IT   IE   SK   ES   PL  
    Global end of trial date
    02 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Jul 2016
    First version publication date
    10 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EMR 63325-021
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02049151
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Merck KGaA Communication Centre, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Merck KGaA Communication Centre, Merck KGaA, +49 6151725200, service@merckgroup.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Poland: 3
    Worldwide total number of subjects
    35
    EEA total number of subjects
    7
    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)
    17
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First/last subject(informed consent): 21 Mar 2014/11 Sep 2014. Study completion date: 02 Jul 2015.

    Pre-assignment
    Screening details
    50 subjects were screened for eligibility; 15 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 35 subjects were randomized. Three subjects were randomized but were not treated.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Tecemotide (L-BLP25) + Cyclophosphamide
    Arm description
    Single dose of cyclophosphamide was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
    Arm type
    Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600mg)

    Investigational medicinal product name
    Tecemotide (L-BLP25)
    Investigational medicinal product code
    EMD531444
    Other name
    BLP25 lipopeptide
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) .

    Arm title
    Placebo + Saline
    Arm description
    Single dose of saline was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
    Arm type
    Active comparator

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received single dose of saline (sodium chloride, 9 gram per liter ( g/L) was administered intravenously.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo doses matched to tecemotide (L-BLP25) was administered subcutaneously.

    Number of subjects in period 1 [1]
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Started
    15
    17
    Completed
    15
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Three subjects were randomized but were not treated. 2 subjects from Tecemotide (L-BLP25) + Cyclophosphamide arm and 1 subjects from Placebo + Saline arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tecemotide (L-BLP25) + Cyclophosphamide
    Reporting group description
    Single dose of cyclophosphamide was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.

    Reporting group title
    Placebo + Saline
    Reporting group description
    Single dose of saline was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.

    Reporting group values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline Total
    Number of subjects
    15 17 32
    Age Categorical
    Units: Subjects
        Greater than equal to (<=) 18 Years
    0 0 0
        Between 18 and 65 Years
    5 10 15
        Less than equal to (>=) 65 Years
    10 7 17
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    66.2 ± 5.99 63.9 ± 10.45 -
    Gender, Male/Female
    Units: Subjects
        Female
    2 7 9
        Male
    13 10 23

    End points

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    End points reporting groups
    Reporting group title
    Tecemotide (L-BLP25) + Cyclophosphamide
    Reporting group description
    Single dose of cyclophosphamide was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.

    Reporting group title
    Placebo + Saline
    Reporting group description
    Single dose of saline was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.

    Primary: Overall Survival Time

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    End point title
    Overall Survival Time [1]
    End point description
    Overall Survival time was defined as the time from randomization to death. Subjects without event were censored at the last date known to be alive or date lost to follow-up, whichever was earlier. Due to termination of the study as a consequence of the discontinuation of the clinical development of tecemotide, the outcome measure was not analyzed.
    End point type
    Primary
    End point timeframe
    Time from date of randomization until death, assessed maximum up to 16 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were performed for this endpoint, only descriptive statistics was reported for this endpoint.
    End point values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [2] - Due to termination of the study the outcome measure was not analyzed.
    [3] - Due to termination of the study the outcome measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Time to Symptom Progression (TTSP)

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    End point title
    Time to Symptom Progression (TTSP)
    End point description
    TTSP was measured using the Lung Cancer Symptom Scale (LCSS). Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI, the mean of the six major lung cancer specific symptom scores of the LCSS scale – ranging from 0 to 100, where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP was defined as the time from randomization to worsening in ASBI. Subjects without event were censored at the date of the last LCSS assessment.Due to termination of the study as a consequence of the discontinuation of the clinical development of tecemotide, outcome measure was not analysed.
    End point type
    Secondary
    End point timeframe
    Time from date of randomization until progressive disease (PD), assessed up to 16 months
    End point values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [4] - Due to termination of the study the outcome measure was not analyzed.
    [5] - Due to termination of the study the outcome measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    Progression Free Survival (PFS)
    End point description
    PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment. Due to termination of the study as a consequence of the discontinuation of the clinical development of tecemotide, the outcome measure was not analyzed.
    End point type
    Secondary
    End point timeframe
    Time from date of randomization until PD or death, assessed up to 16 months
    End point values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [6] - Due to termination of the study the outcome measure was not analyzed.
    [7] - Due to termination of the study the outcome measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

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    End point title
    Time to Progression (TTP)
    End point description
    TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death. Due to termination of the study as a consequence of the discontinuation of the clinical development of tecemotide, outcome measure was not analysed.
    End point type
    Secondary
    End point timeframe
    Time from date of randomization until PD, assessed up to 16 months
    End point values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [8] - Due to termination of the study the outcome measure was not analyzed.
    [9] - Due to termination of the study the outcome measure was not analyzed.
    No statistical analyses for this end point

    Secondary: Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI−CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)

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    End point title
    Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI−CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)
    End point description
    An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI−CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported. Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline.
    End point type
    Secondary
    End point timeframe
    Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months
    End point values
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Number of subjects analysed
    15
    17
    Units: subjects
    number (not applicable)
        TEAEs
    14
    13
        Serious TEAEs
    4
    1
        Grade 3 or 4 TEAEs
    5
    2
        TEAEs Leading to Permanent Discontinuation
    2
    1
        TEAEs leading to death
    0
    0
        ISRs
    0
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Tecemotide (L-BLP25) + Cyclophosphamide
    Reporting group description
    Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented

    Reporting group title
    Placebo + Saline
    Reporting group description
    Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.

    Serious adverse events
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (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
    Tecemotide (L-BLP25) + Cyclophosphamide Placebo + Saline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 15 (93.33%)
    13 / 17 (76.47%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    3 / 15 (20.00%)
    3 / 17 (17.65%)
         occurrences all number
    3
    3
    Chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Feeling hot
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Injection site hypoaesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Injection site bruising
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Contusion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Periorbital haematoma
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Radiation pneumonitis
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Rib fracture
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Cardiac disorders
    Cardiomyopathy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Hypoxia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Laryngeal inflammation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Productive cough
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Nasal congestion
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Lethargy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Tension headache
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Food poisoning
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Faecal incontinence
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 17 (11.76%)
         occurrences all number
    2
    2
    Gingival pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Palmar erythema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Pain of skin
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Groin pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 17 (11.76%)
         occurrences all number
    1
    2
    Hypomagnesaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Ear infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2014
    -The EORTC QLQ C30 was added at the same time points as other QoL questionnaires. The additional questionnaire will further support evaluation of QoL especially considering assessment of general health status aspects. -Subjects with a known history of hepatitis are to be excluded from the trial. To implement a pro-active testing approach and to avoid the risk of exposing subjects potentially suffering from infectious hepatitis and for whom no specific hepatitis B virus (HBV) and/or hepatitis C virus (HCV) diagnostic procedures were recently conducted by clinical sites before trial screening, the corresponding virology blood tests were added. A mandatory HBV and a mandatory HCV test to be performed by a central laboratory will be implemented at screening and, taking into account the disease biology, at Week 32. -Subjects with acquired immunodeficiencies are to be excluded from the trial. To implement a pro-active testing approach and to avoid exposing subjects potentially suffering from HIV infection and for whom no specific HIV diagnostic procedures were recently conducted by clinical sites before trial screening, the corresponding virology blood test was added. A mandatory HIV test to be performed by a central laboratory will be implemented at screening and, taking into account the disease biology, at Week 14. - The rationale for the dosing regimen used in the current study was not specifically noted. A rationale for the dosing was added to Section 3.2 of the clinical trial protocol. -The birth control wording in the clinical trial protocol specified that subjects of childbearing potential would be required to use an adequate form of birth control but did not clearly define adequate contraception. The standard definition for highly effective methods of birth control was added.

    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.
    Sponsor discontinued development of tecemotide (L-BLP25) in NSCLC, hence the study was terminated.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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