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    Clinical Trial Results:
    Phase 3, Randomized, Placebo-Controlled, Double-blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) in Combination with Erlotinib in EGFR Wild-type Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy

    Summary
    EudraCT number
    2013-004371-12
    Trial protocol
    BE   GB   IT   DE   HU   ES   CZ   PL  
    Global end of trial date
    11 Nov 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    14 Dec 2017
    First version publication date
    26 Nov 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    One unclear endpoint was supposed to be deleted because the information is clearly presented in another endpoint.

    Trial information

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    Trial identification
    Sponsor protocol code
    U31287-A-U301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02134015
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mt. Airy Road, Basking Ridge, United States, 07920
    Public contact
    Clinical Trial Information , Daiichi Sankyo Development Limited, 44 1753 482800, euregaffairs@dsd-eu.com
    Scientific contact
    Clinical Trial Information , Daiichi Sankyo Development Limited, 44 1753 482800, euregaffairs@dsd-eu.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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective for Part A of the study is to confirm that the combination regimen of patritumab with erlotinib will improve PFS in HRG-high, EGFR-inhibitor–naïve, EGFR-wild type subjects with locally advanced or metastatic NSCLC who progressed on at least one prior systemic therapy. The primary objective for Part B of the study is to determine if the combination regimen of patritumab with erlotinib will improve OS in EGFR-inhibitor–naïve subjects with locally advanced or metastatic, HRG-high, EGFR-wild type NSCLC who have progressed on at least one prior systemic therapy.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical \Practice (GCP), according to the ICH Harmonized Tripartite Guideline.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 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
    United States: 26
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Italy: 20
    Worldwide total number of subjects
    145
    EEA total number of subjects
    117
    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)
    78
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The first patient was randomized on 11 Jun 2014, and the last patient’s last visit occurred on 11 Nov 2016. All randomized subjects received study treatment and were included in both the Full Analysis Set and the Safety Analysis Set.

    Pre-assignment
    Screening details
    Of 537 patients screened, a total of 145 patients were randomized into this trial in 9 countries: United States (26 at 12 sites), Spain (19 at 5 sites), Hungary (18 at 4 sites), Italy (20 at 6 sites), Great Britain (11 at 5 sites), Poland (30 at 3 sites), Germany (16 at 6 sites), Canada (2 at 1 site) and Belgium (3 at 1 site).

    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 + Erlotinib
    Arm description
    Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
    Arm type
    Placebo

    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
    Placebo was administered as a continuous IV infusion

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral erlotinib tablets 150 mg/day

    Arm title
    Patritumab + Erlotinib
    Arm description
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
    Arm type
    Experimental

    Investigational medicinal product name
    Patritumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral erlotinib tablets 150 mg/day

    Number of subjects in period 1
    Placebo + Erlotinib Patritumab + Erlotinib
    Started
    71
    74
    Completed
    0
    0
    Not completed
    71
    74
         Protocol deviation
    -
    1
         Death
    2
    1
         Reason not provided
    1
    2
         Clinical progression
    14
    7
         Progressive disease (per RECIST 1.1)
    40
    43
         Study terminated by sponsor
    2
    3
         Adverse event, non-fatal
    9
    10
         Consent withdrawn by subject
    3
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Erlotinib
    Reporting group description
    Placebo infusion every 3 weeks and oral erlotinib 150 mg/day

    Reporting group title
    Patritumab + Erlotinib
    Reporting group description
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

    Reporting group values
    Placebo + Erlotinib Patritumab + Erlotinib Total
    Number of subjects
    71 74 145
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    38 40 78
        From 65-84 years
    33 34 67
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.3 ± 9.15 63.9 ± 8.25 -
    Gender categorical
    Units: Subjects
        Female
    22 30 52
        Male
    49 44 93
    Histology subtype
    Units: Subjects
        Adenocarcinoma
    39 40 79
        Squamous
    28 28 56
        Large cell
    1 1 2
        Other
    3 5 8
    Histology Subtype (for Randomization)
    NOS=not otherwise specified
    Units: Subjects
        Adenocarcinoma
    38 40 78
        Squamous-cell carcinoma/NOS
    33 34 67
    ECOG Score
    ECOG=Eastern Cooperative Oncology Group
    Units: Subjects
        0 - Fully Active
    24 25 49
        1 - Restricted in Physically Strenuous Activity
    47 49 96
    HRG Expression from IXRS
    HRG=heregulin; IXRS=Interactive Web/Voice Response System
    Units: Subjects
        High
    48 47 95
        Low
    23 27 50

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Erlotinib
    Reporting group description
    Placebo infusion every 3 weeks and oral erlotinib 150 mg/day

    Reporting group title
    Patritumab + Erlotinib
    Reporting group description
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

    Primary: Part A: Progression Free Survival (PFS) in Heregulin-high Patients

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    End point title
    Part A: Progression Free Survival (PFS) in Heregulin-high Patients [1]
    End point description
    PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method.
    End point type
    Primary
    End point timeframe
    by trial termination (at 20 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: 80% confidence interval is included in the data table.
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    48
    47
    Units: months
        number (confidence interval 80%)
    2.7 (1.7 to 2.9)
    1.9 (1.4 to 3.5)
    No statistical analyses for this end point

    Primary: Part A: PFS in Heregulin-low Patients

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    End point title
    Part A: PFS in Heregulin-low Patients [2]
    End point description
    PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method.
    End point type
    Primary
    End point timeframe
    by trial termination (at 20 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: 80% confidence interval is included in the data table.
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    23
    27
    Units: Months
        number (confidence interval 80%)
    2.8 (1.4 to 4.2)
    1.5 (1.4 to 2.7)
    No statistical analyses for this end point

    Primary: Part B: Primary Endpoint Overall Survival

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    End point title
    Part B: Primary Endpoint Overall Survival [3]
    End point description
    No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    End point type
    Primary
    End point timeframe
    Various Timepoints
    Notes
    [3] - 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: There were no subjects analyzed because the trial was terminated at the end of Part A.
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Percentage of patients
        number (not applicable)
    Notes
    [4] - No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    [5] - No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    No statistical analyses for this end point

    Secondary: Part A: Key secondary efficacy endpoint: Overall Survival

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    End point title
    Part A: Key secondary efficacy endpoint: Overall Survival
    End point description
    Percentage of participants who survived for the length of the trial
    End point type
    Secondary
    End point timeframe
    during Part A
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    71
    74
    Units: Percentage of participants
    number (not applicable)
        HRG High (n=48, 47)
    31.3
    36.2
        HRG Low (n=23,27)
    30.4
    29.6
    No statistical analyses for this end point

    Secondary: Part B: Key secondary efficacy endpoints: PFS; TTD

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    End point title
    Part B: Key secondary efficacy endpoints: PFS; TTD
    End point description
    No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    End point type
    Secondary
    End point timeframe
    Various timepoints
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Percentage of patients
        number (not applicable)
    Notes
    [6] - No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    [7] - No patients were analyzed in Part B endpoints because the trial was terminated at the end of Part A.
    No statistical analyses for this end point

    Secondary: Part A: Key secondary efficacy endpoint: Objective Response Rate (ORR)

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    End point title
    Part A: Key secondary efficacy endpoint: Objective Response Rate (ORR)
    End point description
    Objective response is defined as complete response or partial response
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    Placebo + Erlotinib Patritumab + Erlotinib
    Number of subjects analysed
    71
    74
    Units: Percentage of patients
    number (confidence interval 80%)
        HRG High (n=48,47)
    6.3 (2.4 to 13.7)
    2.2 (0.2 to 8.6)
        HRG Low (n=23,27)
    13.6 (5.3 to 28.6)
    3.7 (0.4 to 14.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    53 days after the last dose of patritumab/placebo or 30 days after the last dose of erlotinib, whichever is later
    Adverse event reporting additional description
    Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo+Erlotinib
    Reporting group description
    Placebo infusion every 3 weeks and oral erlotinib 150 mg/day

    Reporting group title
    Patritumab+Erlotinib
    Reporting group description
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

    Serious adverse events
    Placebo+Erlotinib Patritumab+Erlotinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 71 (40.85%)
    27 / 74 (36.49%)
         number of deaths (all causes)
    5
    5
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tachycardia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 71 (4.23%)
    5 / 74 (6.76%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydropneumothorax
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphagia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen tongue
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (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
    Eczema
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin disorder
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin fissures
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         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
    Bone pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (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
    Hypercalcaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 71 (4.23%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         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
    Placebo+Erlotinib Patritumab+Erlotinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 71 (92.96%)
    68 / 74 (91.89%)
    Vascular disorders
    Pruritus
         subjects affected / exposed
    4 / 71 (5.63%)
    6 / 74 (8.11%)
         occurrences all number
    6
    7
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 71 (11.27%)
    10 / 74 (13.51%)
         occurrences all number
    9
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 71 (5.63%)
    6 / 74 (8.11%)
         occurrences all number
    5
    10
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    16 / 71 (22.54%)
    9 / 74 (12.16%)
         occurrences all number
    21
    11
    Cough
         subjects affected / exposed
    11 / 71 (15.49%)
    10 / 74 (13.51%)
         occurrences all number
    11
    14
    Haemoptysis
         subjects affected / exposed
    5 / 71 (7.04%)
    5 / 74 (6.76%)
         occurrences all number
    7
    7
    Dysphonia
         subjects affected / exposed
    0 / 71 (0.00%)
    4 / 74 (5.41%)
         occurrences all number
    0
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 71 (7.04%)
    0 / 74 (0.00%)
         occurrences all number
    5
    0
    Dysgeusia
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 74 (5.41%)
         occurrences all number
    3
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 71 (23.94%)
    11 / 74 (14.86%)
         occurrences all number
    23
    12
    Oedema peripheral
         subjects affected / exposed
    6 / 71 (8.45%)
    5 / 74 (6.76%)
         occurrences all number
    6
    5
    Asthenia
         subjects affected / exposed
    5 / 71 (7.04%)
    5 / 74 (6.76%)
         occurrences all number
    6
    5
    Chest pain
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 74 (2.70%)
         occurrences all number
    5
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 74 (5.41%)
         occurrences all number
    3
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 71 (30.99%)
    39 / 74 (52.70%)
         occurrences all number
    41
    62
    Nausea
         subjects affected / exposed
    16 / 71 (22.54%)
    15 / 74 (20.27%)
         occurrences all number
    18
    19
    Stomatitis
         subjects affected / exposed
    2 / 71 (2.82%)
    11 / 74 (14.86%)
         occurrences all number
    2
    18
    Vomiting
         subjects affected / exposed
    7 / 71 (9.86%)
    10 / 74 (13.51%)
         occurrences all number
    8
    13
    Constipation
         subjects affected / exposed
    2 / 71 (2.82%)
    9 / 74 (12.16%)
         occurrences all number
    2
    9
    Dyspepsia
         subjects affected / exposed
    3 / 71 (4.23%)
    5 / 74 (6.76%)
         occurrences all number
    3
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    26 / 71 (36.62%)
    28 / 74 (37.84%)
         occurrences all number
    46
    57
    Dermatitis acneiform
         subjects affected / exposed
    6 / 71 (8.45%)
    13 / 74 (17.57%)
         occurrences all number
    7
    23
    Dry skin
         subjects affected / exposed
    7 / 71 (9.86%)
    13 / 74 (17.57%)
         occurrences all number
    7
    14
    Alopecia
         subjects affected / exposed
    3 / 71 (4.23%)
    6 / 74 (8.11%)
         occurrences all number
    4
    6
    Rash maculo-papular
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 74 (4.05%)
         occurrences all number
    4
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    13 / 71 (18.31%)
    17 / 74 (22.97%)
         occurrences all number
    16
    21
    Hypomagnesaemia
         subjects affected / exposed
    4 / 71 (5.63%)
    7 / 74 (9.46%)
         occurrences all number
    7
    17
    Hypokalaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    6 / 74 (8.11%)
         occurrences all number
    1
    6
    Dehydration
         subjects affected / exposed
    1 / 71 (1.41%)
    4 / 74 (5.41%)
         occurrences all number
    1
    4
    Infections and infestations
    Paronychia
         subjects affected / exposed
    3 / 71 (4.23%)
    7 / 74 (9.46%)
         occurrences all number
    4
    16
    Rhinitis
         subjects affected / exposed
    0 / 71 (0.00%)
    4 / 74 (5.41%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2014
    The protocol was modified to clarify packaging and safety requirements, to describe new assessments and time windows, and correct footnotes and formatting.
    12 May 2015
    The study design was modified to create a smaller, more efficient Part A, designed to focus upon efficacy in the high HRG subgroup, for which the primary objective is part of this study.

    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.
    Since there was an unplanned follow up with a patient on 11 Nov 2016, the global end of trial date is actually later than previously reported to health authorities (18-May-2016). The actual global end of trial date is 11-November-2016.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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