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    Clinical Trial Results:
    Estudio aleatorizado de quimioterapia adyuvante individualizada según los niveles de ARNm de BRCA1 en pacientes con cáncer de pulmón no microcítico (estadios II-IIIA) Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients

    Summary
    EudraCT number
    		 2007-000067-15
    Trial protocol
    		 ES  
    Global end of trial date
    01 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2020
    First version publication date
    09 Sep 2020
    Other versions
    Summary report(s)
    		 GECP_SCAT_final report_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GECP-SCAT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00478699
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grupo Español de Cáncer de Pulmón
    Sponsor organisation address
    Avenida Meridiana 358, 6ª planta, Barcelona, Spain, 08027
    Public contact
    Eva Pereira Álvarez, Grupo Español de Cáncer de Pulmón, +34 934302006, epereira@gecp.org
    Scientific contact
    Mariano Provencio,, Grupo Español de Cáncer de Pulmón, +34 934302006, 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 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluar y comparar la supervivencia global entre el grupo de quimioterapia adyuvante estándar no individualizada y los 3 grupos de quimioterapia induividualizada. Evaluate and compare overall survival between the group of Non-individualized standard adjuvant chemotherapy and the 3 subgroups individualized chemotherapy
    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
    02 Jul 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 456
    Worldwide total number of subjects
    456
    EEA total number of subjects
    456
    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)
    200
    From 65 to 84 years
    256
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment was 500 patients in 47 centers between June 2007 and May 2013.

    Pre-assignment
    Screening details
    		 Finally 456 patients were finally selected for final analysis were randomly assigned 101 to a control treatment and 355 to an experimental treatment.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control Arm
    Arm description
    		 Docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both on day 1, every 21 days. Total cycles: 4.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg / m2, on day 1, every 21 days. Total cycles: 4. Docetaxel presentation: 20 and 80 mg vials Route of administration: Intravenous. Therapeutic Group L01C3 A maximum of two dose reductions per patient of each of the chemotherapy agents will be allowed.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose Cisplatin 75 mg / m2, both on day 1, every 21 days. Total cycles: Four. Cisplatin presentation: 10, 25, 50 and 100 mg vials Route of administration: intravenous Therapeutic group: L01E1 A maximum of two dose reductions per patient of each of the chemotherapy agents will be allowed.

    Arm title
    		 Experimental Arm
    Arm description
    		 Experimental group (B), according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned: o Low expression of BRCA1 → gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4 o Intermediate expression levels of BRCA1 → docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4. o High expression levels of BRCA1 → docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intermediate expression levels of BRCA1 and High expression levels of BRCA1 → docetaxel 75 mg / m2, administered on day 1, every 21 days. Total cycles: 4. Docetaxel presentation: 20 and 80 mg vials Route of administration: Intravenous. Therapeutic Group L01C3 A maximum of two dose reductions per patient of each of the chemotherapy agents will be allowed.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose Cisplatin Low expression of BRCA1 and Intermediate expression levels of BRCA1 :75 mg / m2, both on day 1, every 21 days. Total cycles: Four. Cisplatin presentation: 10, 25, 50 and 100 mg vials Route of administration: intravenous Therapeutic group: L01E1 A maximum of two dose reductions per patient of each of the chemotherapy agents will be allowed.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Low expression of BRCA1 → gemcitabine 1250 mg / m2, days 1 and 8. Cycles every 21 days. Total cycles: 4 Gemcitabine, hydrochloride 1 g, and 200 mg vials Route of administration: intravenous Therapeutic group: L01B2

    Number of subjects in period 1
    		Control Arm Experimental Arm
    Started
    101
    355
    Completed
    101
    355

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control Arm
    Reporting group description
    		 Docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both on day 1, every 21 days. Total cycles: 4.

    Reporting group title
    Experimental Arm
    Reporting group description
    		 Experimental group (B), according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned: o Low expression of BRCA1 → gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4 o Intermediate expression levels of BRCA1 → docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4. o High expression levels of BRCA1 → docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.

    Reporting group values
    		 Control Arm Experimental Arm Total
    Number of subjects
    		 101 355 456
    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))
    		 63 (57 to 68) 61 (56 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 22 74 96
        Male
    		 79 281 360
    Smoking habit
    Units: Subjects
        Former smoker
    		 62 221 283
        Smoker
    		 28 102 130
        Never smoker
    		 11 32 43
    Treatment according to BRCA1 level
    Units: Subjects
        Control: Docetaxel and Cisplatin
    		 101 0 101
        Experimental: BRCA1 Low: Gemcitabine / Cisplatin
    		 0 155 155
        Experimental BRCA1 medium: Docetaxel / Cisplatin
    		 0 99 99
        Experimental BRCA1 High: Docetaxel
    		 0 101 101
    Histology
    Units: Subjects
        Adenocarcinomas
    		 47 175 222
        Squamous
    		 46 155 201
        Other
    		 8 25 33
    Staging T
    Units: Subjects
        T1
    		 22 68 90
        T2
    		 64 230 294
        T3
    		 15 57 72
    Staging N
    Units: Subjects
        N1
    		 62 215 277
        N2
    		 39 140 179
    Stage
    Units: Subjects
        IIA
    		 14 38 52
        IIB
    		 37 142 179
        IIIA
    		 50 175 225
    Treatment compliance
    Units: Subjects
        Completed
    		 84 307 391
        Not completed
    		 17 48 65

    End points

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    End points reporting groups
    Reporting group title
    Control Arm
    Reporting group description
    		 Docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both on day 1, every 21 days. Total cycles: 4.

    Reporting group title
    Experimental Arm
    Reporting group description
    		 Experimental group (B), according to the BRAC1 levels of the tumor tissue, one of the following treatments will be assigned: o Low expression of BRCA1 → gemcitabine 1250 mg / m2, days 1 and 8, and cisplatin 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4 o Intermediate expression levels of BRCA1 → docetaxel 75 mg / m2, and cisplatin 75 mg / m2, both administered on day 1, every 21 days. Total cycles: 4. o High expression levels of BRCA1 → docetaxel 75 mg / m2, day 1. Cycles every 21 days. Total cycles: 4.

    Primary: Overall survival

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    End point title
    		 Overall survival
    End point description
    To assess and compare the overall survival between the non-individualized standard adjuvant chemotherapy group and the 3 individualized chemotherapy subgroups.
    End point type
    Primary
    End point timeframe
    Overall survival: it will be measured from the date of inclusion to the date of death from any cause.
    End point values
    		 Control Arm Experimental Arm
    Number of subjects analysed
    101
    355
    Units: Month
    median (confidence interval 95%)
        Control
    57.4 (1.8 to 111.9)
    0 (0 to 0)
        Experimental Low BRCA1: Gemcitabine / Cisplatin
    0 (0 to 0)
    52.8 (1.9 to 104.1)
        Experimental Medium BRCA1: Docetaxel / Cisplatin
    0 (0 to 0)
    49.8 (2 to 120.4)
        Experimental High BRCA1: Docetaxel
    0 (0 to 0)
    51.8 (2.4 to 112.8)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The estimated median survival of the patients included in the study is 79.3 months (95% CI 63.5-95.1 months).
    Comparison groups
    Control Arm v Experimental Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.73 [2]
    Method
    		 long-rank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    52.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 120.4
    Notes
    [1] - No significant differences were observed between the overall survival of the patients assigned to the control group compared to the experimental group (p-value: 0.730).
    [2] - No significant differences were observed between the overall survival of the patients assigned to the control group compared to the experimental group (p-value: 0.730).
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Very significant differences are observed in the overall survival of 280 patients under 65 years of age compared to 176 patients 65 years of age or older at the time of resection (p-value <0.001). The estimated median is 106.4 months for those under 65 years of age and 56.2 months for patients 65 years of age or older.
    Comparison groups
    Experimental Arm v Control Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 long-rank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    106.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56.2
         upper limit
    		 106.4
    Notes
    [3] - Very significant differences are observed in the overall survival of 280 patients under 65 years of age compared to 176 patients 65 years of age or older at the time of resection (p-value <0.001).
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Regarding the overall survival of the patients based on their lymph node involvement, significant differences (p-value: 0.001) were observed in favor of patients with N1 lymph node involvement. (52.0 months for N2 patients and 120.4 for N1 patients)
    Comparison groups
    Control Arm v Experimental Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [4]
    Method
    		 long-rank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    120.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 52
         upper limit
    		 120.4
    Notes
    [4] - Regarding the overall survival of the patients based on their lymph node involvement, significant differences (p-value: 0.001) were observed

    Secondary: Disease free survival

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    End point title
    		 Disease free survival
    End point description
    To assess the disease-free survival of both treatment groups.
    End point type
    Secondary
    End point timeframe
    Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.
    End point values
    		 Control Arm Experimental Arm
    Number of subjects analysed
    101
    355
    Units: Months
    median (confidence interval 80%)
        Control arm
    38.7 (18.6 to 58.8)
    0 (0 to 0)
        Experimental arm
    0 (0 to 0)
    32.7 (24.1 to 41.2)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The comparison of Disease free survival for patients treated in the control group with respect to those treated in the experimental group is made.
    Comparison groups
    Control Arm v Experimental Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.753 [6]
    Method
    		 Iong-Rank
    Parameter type
    		 Median difference (final values)
    Point estimate
    79.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 63.5
         upper limit
    		 95.1
    Notes
    [5] - Regarding progression-free survival for both the control group and the experimental group, no significant differences were observed between the two when applying the long-rank test (p-value = 0.753).
    [6] - Regarding progression-free survival for both the control group and the experimental group, no significant differences were observed.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Very significant differences are observed (p-value: 0.025), as on disease free survival depending on the age of the patients (<65 or > 65). The estimated median to progression is 38.7 months for those under 65 and 27.0 months for those over 65.
    Comparison groups
    Control Arm v Experimental Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025 [7]
    Method
    		 long-rank
    Parameter type
    		 Median difference (final values)
    Point estimate
    38.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28
         upper limit
    		 38.7
    Notes
    [7] - Very significant differences are observed (p-value: 0.025), as on disease free survival depending on the age of the patients (<65 or > 65).
    Statistical analysis title
    		 Statistical analyss 3
    Statistical analysis description
    Also for lymph node involvement, significant differences (p-value: 0.009) were observed with a median progression-free survival of 42.7 months for N1 patients vs 26.2 months for N2 patients.
    Comparison groups
    Control Arm v Experimental Arm
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 long-rank
    Parameter type
    		 Median difference (final values)
    Point estimate
    42.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.2
         upper limit
    		 42.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event or breakdown occurring during the course of the study.
    Adverse event reporting additional description
    The severity of AE will be determined using CTCAE version 3.0.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Subjects per protocol
    Reporting group description
    		 -

    Serious adverse events
    		 Subjects per protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    52 / 456 (11.40%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    4
    Vascular disorders
    Pulmonary thromboembolism
         subjects affected / exposed
    2 / 456 (0.44%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Thrombolysis
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    35 / 456 (7.68%)
         occurrences causally related to treatment / all
    35 / 35
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Anorexy
         subjects affected / exposed
    2 / 456 (0.44%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    9 / 456 (1.97%)
         occurrences causally related to treatment / all
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    Vomits
         subjects affected / exposed
    3 / 456 (0.66%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Mucositis
         subjects affected / exposed
    4 / 456 (0.88%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory infection
         subjects affected / exposed
    6 / 456 (1.32%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmoplantar disease
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal and urinary disorders
    Acute kidney failure
         subjects affected / exposed
    1 / 456 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Subjects per protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    425 / 456 (93.20%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    11 / 456 (2.41%)
         occurrences all number
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    283 / 456 (62.06%)
         occurrences all number
    283
    Fever
         subjects affected / exposed
    20 / 456 (4.39%)
         occurrences all number
    20
    Abdominal pain
         subjects affected / exposed
    11 / 456 (2.41%)
         occurrences all number
    11
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    15 / 456 (3.29%)
         occurrences all number
    15
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    25 / 456 (5.48%)
         occurrences all number
    25
    Cardiac disorders
    Cardiac Arrhythmia
         subjects affected / exposed
    2 / 456 (0.44%)
         occurrences all number
    2
    Nervous system disorders
    Sensitivity in sensory processing
         subjects affected / exposed
    48 / 456 (10.53%)
         occurrences all number
    48
    Blood and lymphatic system disorders
    Hemoglobin
         subjects affected / exposed
    220 / 456 (48.25%)
         occurrences all number
    220
    Leukocites
         subjects affected / exposed
    80 / 456 (17.54%)
         occurrences all number
    80
    Neutrophils
         subjects affected / exposed
    138 / 456 (30.26%)
         occurrences all number
    138
    Platelets
         subjects affected / exposed
    50 / 456 (10.96%)
         occurrences all number
    50
    Epistaxis
         subjects affected / exposed
    5 / 456 (1.10%)
         occurrences all number
    5
    Edema
         subjects affected / exposed
    12 / 456 (2.63%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    8 / 456 (1.75%)
         occurrences all number
    8
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 456 (0.66%)
         occurrences all number
    3
    Gastrointestinal disorders
    Anorexy
         subjects affected / exposed
    63 / 456 (13.82%)
         occurrences all number
    63
    Constipation
         subjects affected / exposed
    57 / 456 (12.50%)
         occurrences all number
    57
    Diarrhea
         subjects affected / exposed
    125 / 456 (27.41%)
         occurrences all number
    125
    Mucositis
         subjects affected / exposed
    93 / 456 (20.39%)
         occurrences all number
    93
    Nausea
         subjects affected / exposed
    182 / 456 (39.91%)
         occurrences all number
    182
    Vomiting
         subjects affected / exposed
    126 / 456 (27.63%)
         occurrences all number
    126
    Epigastralgia
         subjects affected / exposed
    13 / 456 (2.85%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    142 / 456 (31.14%)
         occurrences all number
    142
    Rash
         subjects affected / exposed
    25 / 456 (5.48%)
         occurrences all number
    25
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    17 / 456 (3.73%)
         occurrences all number
    17
    Infections and infestations
    Infection
         subjects affected / exposed
    51 / 456 (11.18%)
         occurrences all number
    51
    Metabolism and nutrition disorders
    GGT alteration
         subjects affected / exposed
    42 / 456 (9.21%)
         occurrences all number
    42
    Creatinine alteration
         subjects affected / exposed
    33 / 456 (7.24%)
         occurrences all number
    33
    GPT/ GOT alterations
         subjects affected / exposed
    37 / 456 (8.11%)
         occurrences all number
    37
    LDH alteration
         subjects affected / exposed
    29 / 456 (6.36%)
         occurrences all number
    29

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2007
    Modification of the criteria that are considered specific for the clinical situation of non-small cell lung cancer with complete surgical resection.
    16 Mar 2009
    Change of quartiles by tertiles in the determination of the expression of BRCA1.
    09 Feb 2012
    Allowing to use Carboplatin as a substitute for Cisplatin due to side effects or poor tolerance in a previous cycle, if the Principal Investigator of any of the participating sites deems it appropriate.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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