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    Clinical Trial Results:
    A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients with Met-Positive Unresectable Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation

    Summary
    EudraCT number
    		 2013-000868-29
    Trial protocol
    		 ES   DE   IT   FR  
    Global end of trial date
    05 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2016
    First version publication date
    07 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO28758
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01887886
    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
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, 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
    Final
    Date of interim/final analysis
    05 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Participants with previously untreated MET-positive NSCLC carrying an activating epidermal growth factor receptor (EGFR) mutation were treated with onartuzumab plus erlotinib (versus placebo plus erlotinib) to evaluate the safety and efficacy of the two-drug combination. The primary efficacy objective was to compare progression-free survival (PFS) as assessed by the investigator.
    Protection of trial subjects
    This study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. The study has complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). Study sites in the United States (US) or under a US Investigational New Drug application (IND) complied with US Food and Drug Administration (FDA) regulations and applicable local, state, and federal laws. Studies conducted in the European Union (EU)/European Economic Area (EEA) complied with the EU Clinical Trial Directive (2001/20/EC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2013
    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
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    10
    EEA total number of subjects
    5
    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)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening tests and evaluations were performed within 28 days prior to Day 1 of Cycle 1. All screening evaluations were required to be completed and reviewed before randomization to confirm that participants met all eligibility criteria.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Onartuzumab + Erlotinib
    Arm description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received onartuzumab as 15 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 milligrams (mg) orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1.

    Investigational medicinal product name
    Onartuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Onartuzumab was given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.

    Arm title
    		 Placebo + Erlotinib
    Arm description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received placebo (matched to onartuzumab) via IV infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered via IV infusion on Day 1 of each 21-day cycle.

    Number of subjects in period 1
    		Onartuzumab + Erlotinib Placebo + Erlotinib
    Started
    5
    5
    Completed
    0
    0
    Not completed
    5
    5
         Consent withdrawn by subject
    1
    -
         Study terminated by Sponsor
    3
    3
         Death
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Onartuzumab + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received onartuzumab as 15 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 milligrams (mg) orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Reporting group title
    Placebo + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received placebo (matched to onartuzumab) via IV infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Reporting group values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib Total
    Number of subjects
    		 5 5 10
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.2 ( 10.8 ) 61 ( 9.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Onartuzumab + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received onartuzumab as 15 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 milligrams (mg) orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Reporting group title
    Placebo + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received placebo (matched to onartuzumab) via IV infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Primary: PFS

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    End point title
    		 PFS [1]
    End point description
    PFS was defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline. Endpoint data were to be analyzed using Kaplan-Meier methodology.
    End point type
    Primary
    End point timeframe
    Tumor assessments every 6 weeks for the first year, then every 9 weeks until disease progression (up to 14 months overall)
    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: The data were not analyzed because the development program was terminated by the Sponsor.
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [2] - The data were not analyzed because the development program was terminated by the Sponsor.
    [3] - The data were not analyzed because the development program was terminated by the Sponsor.
    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 was defined as the time from date of randomization until death from any cause. Endpoint data were to be analyzed using Kaplan-Meier methodology.
    End point type
    Secondary
    End point timeframe
    Continuously during treatment (up to 14 months) and every 3 months until withdrawal, death, or study end (up to 14 months overall)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [4] - The data were not analyzed because the development program was terminated by the Sponsor.
    [5] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Partial or Complete Response According to RECIST v1.1

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    End point title
    		 Percentage of Participants with Partial or Complete Response According to RECIST v1.1
    End point description
    Partial response was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters. Complete response was defined as disappearance of all target lesions. The overall response rate (ORR) was to be determined as the percentage of participants with meeting either set of criteria during the study.
    End point type
    Secondary
    End point timeframe
    Tumor assessments every 6 weeks for the first year, then every 9 weeks until disease progression (up to 14 months overall)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage of participants
        number (not applicable)
    Notes
    [6] - The data were not analyzed because the development program was terminated by the Sponsor.
    [7] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Time to Deterioration (TTD) in Lung Cancer Symptoms

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    End point title
    		 Time to Deterioration (TTD) in Lung Cancer Symptoms
    End point description
    TTD was defined the time from Baseline to first increase (i.e. worsening) in lung cancer symptoms of cough, dyspnea, chest pain, or arm/shoulder pain. Symptom worsening was defined as a ≥10-point increase in the individual item score on the European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30) or EORTC 13-Item Lung Cancer Module (QLQ-LC13). Most questions from the QLQ-C30 and QLQ-LC13 use a 4-point scale (1 equals [=] 'not at all' to 4 = 'very much') except for two questions from the QLQ-C30 that use a 7-point scale (1 = 'very poor' to 7 = 'excellent'). Regardless, item scores are transformed to a scale from 0 to 100, where higher scores indicate a greater degree of symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline, every 3 months during treatment (up to 14 months), within 30 days of last dose, and 3 months after last dose (up to 14 months overall)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: months
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [8] - The data were not analyzed because the development program was terminated by the Sponsor.
    [9] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Change from Baseline in EORTC QLQ-C30 Domain Scores

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    End point title
    		 Change from Baseline in EORTC QLQ-C30 Domain Scores
    End point description
    The EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions use a 4-point scale (1 equals [=] 'not at all' to 4 = 'very much') except for two questions that use a 7-point scale (1 = 'very poor' to 7 = 'excellent'). Regardless, item scores are transformed to a scale from 0 to 100, where higher scores indicate better level of functioning or a greater degree of symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment (up to 14 months)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [10] - The data were not analyzed because the development program was terminated by the Sponsor.
    [11] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Change from Baseline EORTC QLQ-LC13 Domain Scores

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    End point title
    		 Change from Baseline EORTC QLQ-LC13 Domain Scores
    End point description
    The QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise one 3-item scale for dyspnea and ten single-item symptom and side effects scales (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Participants are asked to recall symptoms within the prior week. Questions use a 4-point scale (1 = 'not at all' to 4 = 'very much'). Item scores are transformed to a scale from 0 to 100, where higher scores indicate a greater degree of symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment (up to 14 months)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [12] - The data were not analyzed because the development program was terminated by the Sponsor.
    [13] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve (AUC) of Onartuzumab

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    End point title
    		 Area Under the Concentration-Time Curve (AUC) of Onartuzumab
    End point description
    Serum samples were collected at various timepoints to assess the pharmacokinetics of onartuzumab. The AUC was to be determined for each participant, averaged across all participants, and expressed in micrograms by hours per milliliter (mcg*h/mL).
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 4; post-dose (1 hour after end of infusion) on Day 1 of Cycle 1; and within 30 days of last dose (up to 14 months overall)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: mcg*h/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [14] - The data were not analyzed because the development program was terminated by the Sponsor.
    [15] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Minimum Observed Concentration (Cmin) of Onartuzumab

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    End point title
    		 Minimum Observed Concentration (Cmin) of Onartuzumab
    End point description
    Serum samples were collected at various timepoints to assess the pharmacokinetics of onartuzumab. The Cmin was to be determined for each participant, averaged across all participants, and expressed in micrograms per milliliter (mcg/mL).
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 4
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: mcg/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [16] - The data were not analyzed because the development program was terminated by the Sponsor.
    [17] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Maximum Observed Concentration (Cmax) of Onartuzumab

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    End point title
    		 Maximum Observed Concentration (Cmax) of Onartuzumab
    End point description
    Serum samples were collected to assess the pharmacokinetics of onartuzumab. The Cmax was to be determined for each participant, averaged across all participants, and expressed in mcg/mL.
    End point type
    Secondary
    End point timeframe
    Post-dose (1 hour after end of infusion) on Day 1 of Cycle 1
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: mcg/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [18] - The data were not analyzed because the development program was terminated by the Sponsor.
    [19] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Onartuzumab

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    End point title
    		 Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Onartuzumab
    End point description
    Serum samples were collected at various timepoints to assess for the presence of ATAs to onartuzumab. The percentage of participants who demonstrated ATAs at any time was to be determined.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hours) on Day 1 of Cycles 1 and 4 and within 30 days of last dose (up to 14 months overall)
    End point values
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: percentage of participants
        number (not applicable)
    Notes
    [20] - The data were not analyzed because the development program was terminated by the Sponsor.
    [21] - The data were not analyzed because the development program was terminated by the Sponsor.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Continuously during treatment (up to 14 months) and within 30 days of last dose (up to 14 months overall)
    Adverse event reporting additional description
    Safety Population: All participants who received at least one dose of study medication.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Onartuzumab + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received onartuzumab as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Reporting group title
    Placebo + Erlotinib
    Reporting group description
    		 Participants with MET receptor-positive, unresectable Stage IIIB or Stage IV NSCLC carrying an activating EGFR mutation received placebo (matched to onartuzumab) via IV infusion on Day 1 of each 21-day cycle. Erlotinib tablets were administered as 150 mg orally once daily beginning on Day 1 of Cycle 1. Treatment continued until disease progression, unacceptable toxicity, withdrawal, death, or termination of the study.

    Serious adverse events
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (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
    		 Onartuzumab + Erlotinib Placebo + Erlotinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Axillary pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 5 (20.00%)
         occurrences all number
    3
    2
    Gait disturbance
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Mucosal inflammation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Haemoptysis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    2
    Paraesthesia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Visual field defect
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 5 (40.00%)
    3 / 5 (60.00%)
         occurrences all number
    2
    4
    Dry mouth
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 5 (40.00%)
    5 / 5 (100.00%)
         occurrences all number
    2
    5
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         occurrences all number
    3
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Alopecia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    4 / 5 (80.00%)
    3 / 5 (60.00%)
         occurrences all number
    7
    3
    Pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         occurrences all number
    3
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Feb 2015
    The study was terminated following concerns that the addition of onartuzumab to erlotinib could have the potential to shorten survival in previously untreated patients with MET-positive EGFR-mutant locally advanced or metastatic NSCLC.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Because the study was terminated early, the study results were reported in an abbreviated format that did not include analysis of efficacy or pharmacokinetic data. Only safety results are reported herein.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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