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    Clinical Trial Results:
    A Randomized Phase 2 Study of Pemetrexed in Combination with Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2005-002911-26
    Trial protocol
    		 DE   ES  
    Global end of trial date
    30 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H3E-SB-S089
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00269152
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial ID: 10105, Trial Alias: H3E-SB-S089
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center , Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 800-285-4559,
    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
    30 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
    Protection of trial subjects
    This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 87
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    France: 20
    Worldwide total number of subjects
    122
    EEA total number of subjects
    122
    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)
    82
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not Applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pemetrexed + Cisplatin
    Arm description
    		 Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY213514, Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles

    Arm title
    		 Pemetrexed + Carboplatin
    Arm description
    		 Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY213514, Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles

    Number of subjects in period 1
    		Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Started
    63
    59
    Completed
    45
    49
    Not completed
    18
    10
         Physician decision
    2
    3
         Adverse event, non-fatal
    9
    3
         Protocol violation
    -
    1
         Withdrawal by subject
    7
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pemetrexed + Cisplatin
    Reporting group description
    		 Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles

    Reporting group title
    Pemetrexed + Carboplatin
    Reporting group description
    		 Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles

    Reporting group values
    		 Pemetrexed + Cisplatin Pemetrexed + Carboplatin Total
    Number of subjects
    		 63 59 122
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ± 7.7 58.9 ± 7.2 -
    Gender, Male/Female
    Units: participants
        Female
    		 14 18 32
        Male
    		 49 41 90
    Race, Customized
    Units: Subjects
        Caucasian
    		 62 58 120
        African
    		 1 1 2
    Region of Enrollment
    Units: Subjects
        France
    		 12 8 20
        Spain
    		 7 8 15
        Germany
    		 44 43 87
    Curative Surgery Used
    Units: Subjects
        Pneumonectomy
    		 9 9 18
        Lobectomy
    		 46 46 92
        Bi-lobectomy
    		 8 4 12
    Smoking History
    Units: Subjects
        Yes
    		 56 56 112
        No
    		 7 3 10
    Stage of Disease Prior to Tumor Resection
    Classification based on the American Joint Committee on Cancer Staging Criteria for Lung Cancer.
    Units: Subjects
        Stage Ia
    		 0 1 1
        Stage Ib
    		 27 26 53
        Stage IIa
    		 6 5 11
        Stage IIb
    		 30 25 55
        Stage IIIa
    		 0 1 1
        Unknown: could have been either Stage IIIb or IV
    		 0 1 1
    Tumor Type at Initial Pathological Diagnosis
    Units: Subjects
        Adenocarcinoma of the Lung
    		 27 23 50
        Squamous Carcinoma of the Lung
    		 24 20 44
        Non-Small Cell Lung Cancer
    		 5 4 9
        Mixed Cell (Squamous/Adeno) Carcinoma of Lung
    		 0 5 5
        Large Cell Carcinoma of Lung
    		 5 7 12
        Bronchoalveolar Carcinoma
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Pemetrexed + Cisplatin
    Reporting group description
    		 Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles

    Reporting group title
    Pemetrexed + Carboplatin
    Reporting group description
    		 Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles

    Subject analysis set title
    Pemetrexed+Cisplatin (Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    1 patient randomized to pemetrexed+carboplatin was accidentally treated with pemetrexed+cisplatin. This patient was analyzed for efficacy as randomized and for safety as treated.

    Primary: The Feasibility of Adjuvant Chemotherapy

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    End point title
    		 The Feasibility of Adjuvant Chemotherapy [1] [2]
    End point description
    The purpose of the study was to determine the feasibility rate of the treatment regimen. The treatment was considered feasible if the participant was able to complete 4 cycles of chemotherapy as defined by the protocol, was alive, and showed no Grade 3 toxicities at the follow-up visit 30 days after the last infusion of study drugs.
    End point type
    Primary
    End point timeframe
    every 21-day cycle for 4 cycles up to 30 days after last infusion
    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: Unable to provide statistical analysis for single reporting group with no comparison group due to system limitations in EudraCT database.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Unable to provide statistical analysis for single reporting group with no comparison group due to system limitations in EudraCT database.
    End point values
    		 Pemetrexed + Carboplatin Pemetrexed+Cisplatin (Safety)
    Number of subjects analysed
    54
    64
    Units: participants
    number (not applicable)
        Participants "feasible"
    27
    38
        Non-feasible = Early Discontinuation
    6
    18
        Non-feasible = Lost to Follow-up
    2
    1
        Non-feasible = Remaining Grade 3/4 Toxicity
    3
    4
        Non-feasible = Underdosage (<95% intended dose)
    19
    5
    No statistical analyses for this end point

    Secondary: Grade III/IV Adverse Events

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    End point title
    		 Grade III/IV Adverse Events [3]
    End point description
    Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
    End point type
    Secondary
    End point timeframe
    every 21-day cycle for 4 cycles
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Unable to provide statistical analysis for single reporting group with no comparison group due to system limitations in EudraCT database.
    End point values
    		 Pemetrexed + Carboplatin Pemetrexed+Cisplatin (Safety)
    Number of subjects analysed
    54
    64
    Units: participants
    number (not applicable)
        Neutropenia
    6
    9
        Anaemia
    3
    0
        Thrombocytopenia
    3
    0
        Febrile neutropenia
    2
    0
        Leukopenia
    1
    0
        Lymphopenia
    0
    1
        Neutrophil count decreased
    6
    1
        Haemoglobin count decreased
    2
    0
        Platelet count decreased
    1
    1
        White blood cell count decreased
    2
    0
        Asthenia
    2
    4
        Nausea
    0
    3
        Vomiting
    0
    3
        Fatigue
    2
    0
        Catheter related infection
    0
    1
        Gamma-glutamyltransferase increased
    0
    1
        Anorexia
    0
    1
        Hyperglycaemia
    0
    1
        Hyperkalaemia
    0
    1
        Psychotic disorder
    0
    1
    No statistical analyses for this end point

    Secondary: Overall Survival at 3 Years

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    End point title
    		 Overall Survival at 3 Years
    End point description
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
    End point type
    Secondary
    End point timeframe
    baseline to date of death from any cause, assessed at 3 years
    End point values
    		 Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Number of subjects analysed
    63
    59
    Units: percent probability of survival (%)
        number (confidence interval 95%)
    82 (72.4 to 91.6)
    83.2 (73.2 to 93.2)
    No statistical analyses for this end point

    Secondary: 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years

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    End point title
    		 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years
    End point description
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.
    End point type
    Secondary
    End point timeframe
    length of time disease free, assessed at 3 years
    End point values
    		 Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Number of subjects analysed
    63
    59
    Units: probability of disease-free survival (%)
        number (confidence interval 95%)
    61.2 (48.3 to 74)
    67.3 (54.5 to 80.1)
    No statistical analyses for this end point

    Secondary: Overall Survival at 6 Years

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    End point title
    		 Overall Survival at 6 Years
    End point description
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
    End point type
    Secondary
    End point timeframe
    Baseline to date of death from any cause assessed at 6 years
    End point values
    		 Pemetrexed + Cisplatin Pemetrexed + Carboplatin
    Number of subjects analysed
    63
    59
    Units: percent probability of survival (%)
        number (confidence interval 95%)
    72.6 (59.3 to 85.9)
    83.2 (73.2 to 93.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H3E-SB-S089
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Pemetrexed and Carboplatin
    Reporting group description
    		 -

    Reporting group title
    Pemetrexed and Cisplatin
    Reporting group description
    		 -

    Serious adverse events
    		 Pemetrexed and Carboplatin Pemetrexed and Cisplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 54 (9.26%)
    19 / 64 (29.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    cancer pain
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    aortic aneurysm
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral ischaemia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    atrial flutter
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute myocardial infarction
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tachyarrhythmia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         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
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         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
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    visual disturbance
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 64 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    splenic artery aneurysm
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 64 (4.69%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    5 / 64 (7.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 64 (4.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychotic disorder
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    restlessness
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    catheter related infection
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    anorexia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pemetrexed and Carboplatin Pemetrexed and Cisplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 54 (92.59%)
    59 / 64 (92.19%)
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    13 / 54 (24.07%)
    10 / 64 (15.63%)
         occurrences all number
    15
    22
    chest pain
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 64 (4.69%)
         occurrences all number
    6
    3
    fatigue
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    21 / 54 (38.89%)
    23 / 64 (35.94%)
         occurrences all number
    25
    40
    mucosal inflammation
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    2 / 54 (3.70%)
    6 / 64 (9.38%)
         occurrences all number
    2
    7
    pyrexia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 64 (4.69%)
         occurrences all number
    4
    3
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    16 / 54 (29.63%)
    6 / 64 (9.38%)
         occurrences all number
    19
    7
    epistaxis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 64 (3.13%)
         occurrences all number
    6
    2
    dyspnoea
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    9 / 54 (16.67%)
    7 / 64 (10.94%)
         occurrences all number
    10
    8
    Psychiatric disorders
    sleep disorder
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    4 / 64 (6.25%)
         occurrences all number
    4
    6
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    6 / 54 (11.11%)
    0 / 64 (0.00%)
         occurrences all number
    8
    0
    haemoglobin decreased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 64 (3.13%)
         occurrences all number
    11
    2
    neutrophil count decreased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    10 / 54 (18.52%)
    4 / 64 (6.25%)
         occurrences all number
    22
    11
    platelet count decreased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    10 / 54 (18.52%)
    4 / 64 (6.25%)
         occurrences all number
    16
    9
    weight decreased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 64 (4.69%)
         occurrences all number
    3
    5
    white blood cell count decreased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    9 / 54 (16.67%)
    2 / 64 (3.13%)
         occurrences all number
    17
    4
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    4 / 64 (6.25%)
         occurrences all number
    3
    5
    dysgeusia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    7 / 54 (12.96%)
    3 / 64 (4.69%)
         occurrences all number
    9
    4
    headache
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    6 / 54 (11.11%)
    8 / 64 (12.50%)
         occurrences all number
    8
    12
    paraesthesia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 64 (4.69%)
         occurrences all number
    4
    3
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    8 / 54 (14.81%)
    12 / 64 (18.75%)
         occurrences all number
    9
    14
    neutropenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    15 / 54 (27.78%)
    21 / 64 (32.81%)
         occurrences all number
    36
    34
    leukopenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    5 / 64 (7.81%)
         occurrences all number
    4
    8
    thrombocytopenia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    7 / 54 (12.96%)
    3 / 64 (4.69%)
         occurrences all number
    12
    3
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 64 (1.56%)
         occurrences all number
    3
    1
    Eye disorders
    conjunctivitis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    6 / 54 (11.11%)
    1 / 64 (1.56%)
         occurrences all number
    7
    1
    lacrimation increased
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 64 (3.13%)
         occurrences all number
    3
    3
    keratoconjunctivitis sicca
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 64 (1.56%)
         occurrences all number
    3
    3
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    5 / 54 (9.26%)
    6 / 64 (9.38%)
         occurrences all number
    6
    7
    diarrhoea
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    7 / 54 (12.96%)
    5 / 64 (7.81%)
         occurrences all number
    11
    7
    constipation
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    8 / 54 (14.81%)
    17 / 64 (26.56%)
         occurrences all number
    10
    30
    dyspepsia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 64 (6.25%)
         occurrences all number
    4
    5
    dysphagia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 64 (3.13%)
         occurrences all number
    3
    2
    nausea
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    30 / 54 (55.56%)
    40 / 64 (62.50%)
         occurrences all number
    60
    82
    stomatitis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    5 / 54 (9.26%)
    3 / 64 (4.69%)
         occurrences all number
    7
    4
    vomiting
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    17 / 54 (31.48%)
    21 / 64 (32.81%)
         occurrences all number
    24
    31
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    5 / 54 (9.26%)
    4 / 64 (6.25%)
         occurrences all number
    5
    4
    pruritus
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 64 (1.56%)
         occurrences all number
    3
    1
    rash
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 64 (3.13%)
         occurrences all number
    4
    3
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 64 (6.25%)
         occurrences all number
    1
    4
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 64 (3.13%)
         occurrences all number
    5
    2
    Metabolism and nutrition disorders
    anorexia
    alternative dictionary used: MedDRA 8.1
         subjects affected / exposed
    14 / 54 (25.93%)
    10 / 64 (15.63%)
         occurrences all number
    19
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2011
    A protocol amendment after the trial original completed to allow for additional 3 years for collection of additional overall survival data due to number of participants surviving at 3 years. Long-term survival follow-up was increased by this amendment to 6 years.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Mar 2008
    The protocol was amended to extend the long-term follow-up period to 6 years to allow for collection of additional overall survival data.
    30 May 2011

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