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    Clinical Trial Results:
    Estudio fase III, multicéntrico, abierto, randomizado de tratamiento con erlotinib (Tarceva®) versus quimioterapia en pacientes con carcinoma no microcítico de pulmón avanzado que presentan mutaciones en el dominio tirosina quinasa (TK) del Receptor del Factor de Crecimiento Epidérmico (EGFR) A phase III, multicenter, open-label, randomized trial of erlotinib (Tarceva®) versus chemotherapy in patients with advanced non-small cell lung cancer with mutations in the tyrosine kinase domain of the Epidermal Growth Factor Receptor (EGFR)

    Summary
    EudraCT number
    		 2006-003568-73
    Trial protocol
    		 FR   IT   ES  
    Global end of trial date
    11 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2025
    First version publication date
    22 Feb 2025
    Other versions
    Summary report(s)
    		 Lancet Oncol article_EURTAC

    Trial information

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    Trial identification
    Sponsor protocol code
    GECP06/01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00446225
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spanish Lung Cancer Group
    Sponsor organisation address
    Avda. Meridiana 358; 6th floor, Barcelona, Spain, 08027
    Public contact
    Eva Pereira, Spanish Lung Cancer Group, 34 93 4302006, epereira@gecp.org
    Scientific contact
    Eva Pereira, Spanish Lung Cancer Group, 34 93 4302006, epereira@gecp.org
    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
    11 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparar la supervivencia libre de progresión, evaluada por el investigador, en los dos brazos de tratamiento del estudio (quimioterapia convencional versus erlotinib) en pacientes con cáncer de pulmón no microcítico (CPNM) en estadios avanzados (estadio IIIB y estadio IV), que no han recibido quimioterapia previa para su enfermedad y que presentan mutaciones en el dominio tirosina quinasa del receptor del factor de crecimiento epidérmico (EGFR).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Feb 2007
    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
    Spain: 115
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Italy: 19
    Worldwide total number of subjects
    173
    EEA total number of subjects
    173
    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)
    86
    From 65 to 84 years
    87
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled in the study from 42 hospitals in France, Italy, and Spain.

    Pre-assignment
    Screening details
    		 Screening details: Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental: Erlotinib
    Arm description
    		 Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Tarceva
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib (Tarceva)150 mg /day For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib These tablets are typically taken once a day, with or without food Patients will receive treatment until disease progression or unacceptable toxicity.

    Arm title
    		 Control: Standard Chemotherapy Group
    Arm description
    		 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy -75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or -75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: -3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or -3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Paraplatin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2 days 1 and 8 and Carboplatin AUC = 5 day 1, every 21 days. Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5) Repeat cycles every 3 weeks. Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Investigational medicinal product name
    Gemcitabin
    Investigational medicinal product code
    Other name
    Gemzar
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8) Repeat cycles every 3 weeks. Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Repeat cycles every 3 weeks. Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Platinol
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v. day 1. Repeat cycles every 3 weeks. - Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks. Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Number of subjects in period 1
    		Experimental: Erlotinib Control: Standard Chemotherapy Group
    Started
    86
    87
    Completed
    86
    87

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: Erlotinib
    Reporting group description
    		 Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

    Reporting group title
    Control: Standard Chemotherapy Group
    Reporting group description
    		 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy -75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or -75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: -3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or -3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Reporting group values
    		 Experimental: Erlotinib Control: Standard Chemotherapy Group Total
    Number of subjects
    		 86 87 173
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 65 (53 to 82) 65 (46 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 58 68 126
        Male
    		 28 19 47
    Race (NIH/OMB)
    Units: Subjects
        White
    		 86 85 171
        Not recorded
    		 0 2 2
    Smoking status
    Units: Subjects
        Never smoked
    		 57 63 120
        Previous smoker
    		 22 12 34
        Current smoker
    		 7 12 19
    ECOG Performance Status Scale
    Units: Subjects
        ECOG 0
    		 27 30 57
        ECOG 1
    		 47 45 92
        ECOG 2
    		 12 12 24
    Clinical stage
    Units: Subjects
        Stage IIIA
    		 1 0 1
        Stage IIIB
    		 6 5 11
        Stage IV
    		 78 82 160
        Stage IIIC
    		 1 0 1
    Bone metastasis
    Units: Subjects
        Yes
    		 9 11 20
        No
    		 77 76 153
    Brain metastasis
    Units: Subjects
        Yes
    		 9 11 20
        No
    		 77 76 153
    Type of EGFR mutation
    Units: Subjects
        Deletion of exon 19
    		 57 58 115
        L858R mutation in exon 21
    		 29 29 58

    End points

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    End points reporting groups
    Reporting group title
    Experimental: Erlotinib
    Reporting group description
    		 Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

    Reporting group title
    Control: Standard Chemotherapy Group
    Reporting group description
    		 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy -75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or -75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: -3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or -3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

    Primary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
    End point type
    Primary
    End point timeframe
    From the date of randomization to the date of last follow up, assessed up to 24 months
    End point values
    		 Experimental: Erlotinib Control: Standard Chemotherapy Group
    Number of subjects analysed
    86
    87
    Units: Months
        median (confidence interval 95%)
    9.4 (7.9 to 12.3)
    5.2 (4.4 to 5.8)
    Statistical analysis title
    		 PFS between groups
    Comparison groups
    Experimental: Erlotinib v Control: Standard Chemotherapy Group
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 0.64

    Secondary: Objective Response

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    End point title
    		 Objective Response
    End point description
    The objective response is defined as the numbr of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.
    End point type
    Secondary
    End point timeframe
    From the date of randomization to the date of last follow up, assessed up to 24 months
    End point values
    		 Experimental: Erlotinib Control: Standard Chemotherapy Group
    Number of subjects analysed
    86
    87
    Units: Participant
        Complete Response (CR)
    2
    0
        Partial Response (PR)
    54
    14
        Stable Disease (SD)
    16
    43
        Progressive Disease (PD)
    6
    11
        Missing (No Response Assessment)
    8
    19
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.
    End point type
    Secondary
    End point timeframe
    From the date of randomization to the date of last follow up, assessed up to 24 months
    End point values
    		 Experimental: Erlotinib Control: Standard Chemotherapy Group
    Number of subjects analysed
    86
    87
    Units: month
        median (confidence interval 95%)
    33.4 (26.7 to 39)
    29.9 (25 to 32.1)
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    Experimental: Erlotinib v Control: Standard Chemotherapy Group
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.99

    Secondary: Serum EGFR Mutation Status

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    End point title
    		 Serum EGFR Mutation Status
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline
    End point values
    		 Experimental: Erlotinib Control: Standard Chemotherapy Group
    Number of subjects analysed
    86
    87
    Units: Sample of serum
        Mutated
    30
    29
        Wild type
    24
    23
        Not enough sample
    2
    2
        Not sample
    30
    33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of randomization until 100 days after last dose of study treatment, assessed up to 36 months.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.0
    Reporting groups
    Reporting group title
    Erlotinib Group
    Reporting group description
    		 -

    Reporting group title
    Standard chemotherapy group
    Reporting group description
    		 -

    Serious adverse events
    		 Erlotinib Group Standard chemotherapy group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 86 (31.40%)
    25 / 87 (28.74%)
         number of deaths (all causes)
    55
    54
         number of deaths resulting from adverse events
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasic pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Respiratory failure
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Aplasia cutis congenita
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac tamponade
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ischaemic stroke
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 86 (0.00%)
    5 / 87 (5.75%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 86 (0.00%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Infectious pleural effusion
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sigmoiditis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 86 (1.16%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (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
    		 Erlotinib Group Standard chemotherapy group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 86 (95.35%)
    81 / 87 (93.10%)
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    8 / 86 (9.30%)
    12 / 87 (13.79%)
         occurrences all number
    8
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    48 / 86 (55.81%)
    59 / 87 (67.82%)
         occurrences all number
    48
    59
    Appetite loss
         subjects affected / exposed
    26 / 86 (30.23%)
    28 / 87 (32.18%)
         occurrences all number
    26
    28
    Anaemia
         subjects affected / exposed
    10 / 86 (11.63%)
    40 / 87 (45.98%)
         occurrences all number
    10
    40
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 86 (0.00%)
    27 / 87 (31.03%)
         occurrences all number
    0
    27
    Thrombocytopenia
         subjects affected / exposed
    1 / 86 (1.16%)
    7 / 87 (8.05%)
         occurrences all number
    1
    7
    Aminotransferase rise
         subjects affected / exposed
    5 / 86 (5.81%)
    5 / 87 (5.75%)
         occurrences all number
    5
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    48 / 86 (55.81%)
    15 / 87 (17.24%)
         occurrences all number
    48
    15
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 87 (1.15%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    67 / 86 (77.91%)
    4 / 87 (4.60%)
         occurrences all number
    67
    4
    Alopecia
         subjects affected / exposed
    12 / 86 (13.95%)
    15 / 87 (17.24%)
         occurrences all number
    12
    15
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 86 (10.47%)
    5 / 87 (5.75%)
         occurrences all number
    9
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Dec 2006
    Adjust the dose of cisplatin when combined with gemcitabine to the standard dose in the clinical practice and modifiy selection criteria, modify secondary objectives.
    09 Jun 2008
    Incorporate the participation of an external evaluator of the imaging tests used for the assessment of the tumor response to the study treatment and Incorporate the participation of two more countries and unify the versions existing in the participating countries.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22285168
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