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    The EU Clinical Trials Register currently displays   44043   clinical trials with a EudraCT protocol, of which   7319   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    A multicentre, randomised, phase III trial of platinum-based chemotherapy versus non-platinum chemotherapy, after ERCC1 stratification, in patients with advanced/metastatic non-small cell lung cancer

    Summary
    EudraCT number
    2007-007639-17
    Trial protocol
    GB  
    Global end of trial date
    18 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Sep 2016
    First version publication date
    02 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/07/158
    Additional study identifiers
    ISRCTN number
    ISRCTN02370070
    US NCT number
    NCT00801736
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    CR UK and UCL Cancer Trials Centre, University College London, ctc.et@ucl.ac.uk
    Scientific contact
    CR UK and UCL Cancer Trials Centre, University College London, ctc.et@ucl.ac.uk
    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
    18 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The trial will have two main objectives: 1) To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment. 2) To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment. Squamous cell patients will receive gemcitabine with either cisplatin or paclitaxel. Non-squamous cell patients will receive pemetrexed with either cisplatin or paclitaxel.
    Protection of trial subjects
    Patient safety was monitored using regular patient assessments, dose modifications for regular review of safety data by the Independent Data Monitoring Committee (IDMC) and Trial Management Group (TMG) and through strict eligibility criteria. Patient data is stored in a secure manner and UCL CTC trials are registered in accordance with the Data Protection Act 1998 and the Data Protection Officer at UCL.
    Background therapy
    All patients receiving the pemetrexed-containing regimens received 350-1000 micrograms oral folic acid throughout treatment and 1000 micrograms of intramuscular vitamin B12 every 9 weeks. It was recommended that patients receiving cisplatin were given a 3-drug anti-emetic combination of a 5-HT3 seratonin receptor antagonist, dexamethasone and aprepitant. it was recommended that patients receiving paclitaxel were given a 2-drug anti-emetic combination of a 5-HC3 seratonin receptor antagonist and dexamethasone.
    Evidence for comparator
    For squamous patients the comparator was cisplatin/gemcitabine. For non-squamous patients the comparator was cisplatin/pemetrexed. A meta-analysis of two large randomised trials demonstrated that patients with squamous histology have a lower survival than non-squamous patients. One trial randomised patients to cisplatin/pemetrexed or cisplatin/gemcitabine. Non-squamous patients receiving pemetrexed-based therapy had an improved outcome however squamous histology patient had a worse outcome. Based on these findings, together with the licensing indication of cisplatin/pemetrexed being restricted to non-squamous patients only, the ET trial used gemcitabine in the platinum/non-platinum doublets for squamous patients instead of pemetrexed. Cisplatin/pemetrexed was chosen as the comparator for non-squamous patients as previous studies of pemetrexed have shown it to be well tolerated as a treatment for NSCLC when given alongside platinum chemotherapy. In the largest randomised study conducted for advanced NSCLC, cisplatin/pemetrexed was found to be non-inferior to cisplatin/gemcitabine, an effective widely-used reference regimen for the front-line treatment of advanced NSCLC. However patients treated with cisplatin/pemetrexed developed significantly less toxicity and those with non-squamous histology had a statistically superior overall survival.
    Actual start date of recruitment
    06 Oct 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 637
    Worldwide total number of subjects
    637
    EEA total number of subjects
    637
    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)
    326
    From 65 to 84 years
    311
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were randomised into the trial between 07/10/09 and 24/07/13. 648 patients were randomised from NHS hospitals across the UK.

    Pre-assignment
    Screening details
    - Staging scans performed no more than 28 days prior to registration or randomisation - Adequate bone marrow, liver and renal function assessed within 14 days of registration - Other pre-registration assessments to be performed within 21 days of registration (inc physical examination, assessment of adverse events, quality of life questionnaires)

    Period 1
    Period 1 title
    Overall trial (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
    Squamous patients: cisplatin/gemcitabine Non-squamous patients: cisplatin/pemetrexed
    Arm type
    Active comparator

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75mg/m2 on Day 1 of 21 day cycles. Up to 6 cycles given in total.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250mg/m2 on Day 1 and Day 8 of 21 day cycles. Up to 6 cycles in total.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500mg/m2 on Day 1 of 21 day cycles. Up to 6 cycles in total.

    Arm title
    Investigational Arm
    Arm description
    Squamous patients: paclitaxel/gemcitabine Non-squamous patients: paclitaxel/pemetrexed
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500mg/m2 on Day 1 of 21 day cycles. Up to 6 cycles in total.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    175mg/m2 on Day 1 of 21 day cycle. Up to 6 cycles in total.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250mg/m2 on Day 1 and Day 8 of 21 day cycles. Up to 6 cycles in total.

    Number of subjects in period 1
    Control Arm Investigational Arm
    Started
    314
    323
    Completed
    314
    323

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    637 637
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    326 326
        From 65-84 years
    311 311
    Gender categorical
    Units: Subjects
        Female
    244 244
        Male
    393 393
    ECOG Performance Status
    Units: Subjects
        PS 0
    275 275
        PS 1
    362 362
    Disease Stage
    Units: Subjects
        IIIb
    148 148
        IV
    489 489
    Smoking Status
    Units: Subjects
        Never
    52 52
        Former
    270 270
        Current
    315 315
    ERCC1 Status
    Units: Subjects
        Negative
    251 251
        Positive
    386 386
    XFP Status
    Units: Subjects
        Negative
    142 142
        Positive
    333 333
        Unavailable
    162 162

    End points

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    End points reporting groups
    Reporting group title
    Control Arm
    Reporting group description
    Squamous patients: cisplatin/gemcitabine Non-squamous patients: cisplatin/pemetrexed

    Reporting group title
    Investigational Arm
    Reporting group description
    Squamous patients: paclitaxel/gemcitabine Non-squamous patients: paclitaxel/pemetrexed

    Primary: Overall survival

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    End point title
    Overall survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    From start of randomisation until primary completion date.
    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: Overall survival HR (95% CI) Nonsquamous ERCC1 negative 0.98 (0.72-1.34) ERCC1 positive 1.15 (0.88-1.51) Squamous ERCC1 negative 1.56 (0.79-3.08) ERCC1 positive 1.40 (0.97-2.03)
    End point values
    Control Arm Investigational Arm
    Number of subjects analysed
    314
    323
    Units: Months
    median (confidence interval 95%)
        Overall Survival for Squamous Patients
    11.4 (7 to 19.6)
    8.7 (4.1 to 15.4)
        Overall Survival for Non-Squamous Patients
    10.9 (6.1 to 16.8)
    9.5 (4.8 to 17.7)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to primary completion date
    End point values
    Control Arm Investigational Arm
    Number of subjects analysed
    314
    323
    Units: Months
    median (confidence interval 95%)
        Squamous Patients
    7.8 (3.7 to 12.6)
    5 (2.6 to 8.8)
        Non-Squamous Patients
    6.9 (2.9 to 10.7)
    5.5 (2.2 to 9.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent until 24 months post randomisation
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    All Patients
    Reporting group description
    -

    Serious adverse events
    All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    275 / 637 (43.17%)
         number of deaths (all causes)
    563
         number of deaths resulting from adverse events
    4
    Investigations
    Platelet count abnormal
         subjects affected / exposed
    8 / 637 (1.26%)
         occurrences causally related to treatment / all
    7 / 8
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    19 / 637 (2.98%)
         occurrences causally related to treatment / all
    10 / 19
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Heart
         subjects affected / exposed
    25 / 637 (3.92%)
         occurrences causally related to treatment / all
    9 / 25
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 637 (2.67%)
         occurrences causally related to treatment / all
    15 / 17
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    40 / 637 (6.28%)
         occurrences causally related to treatment / all
    37 / 40
         deaths causally related to treatment / all
    1 / 1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 637 (1.26%)
         occurrences causally related to treatment / all
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    26 / 637 (4.08%)
         occurrences causally related to treatment / all
    19 / 26
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    26 / 637 (4.08%)
         occurrences causally related to treatment / all
    3 / 26
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylaxis
         subjects affected / exposed
    9 / 637 (1.41%)
         occurrences causally related to treatment / all
    8 / 9
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    25 / 637 (3.92%)
         occurrences causally related to treatment / all
    20 / 25
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    22 / 637 (3.45%)
         occurrences causally related to treatment / all
    18 / 22
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    29 / 637 (4.55%)
         occurrences causally related to treatment / all
    24 / 29
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    15 / 637 (2.35%)
         occurrences causally related to treatment / all
    5 / 15
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    33 / 637 (5.18%)
         occurrences causally related to treatment / all
    3 / 33
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    10 / 637 (1.57%)
         occurrences causally related to treatment / all
    5 / 10
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    87 / 637 (13.66%)
         occurrences causally related to treatment / all
    40 / 87
         deaths causally related to treatment / all
    3 / 3
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    8 / 637 (1.26%)
         occurrences causally related to treatment / all
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    472 / 637 (74.10%)
    Investigations
    Alkaline Phosphatase Raised
         subjects affected / exposed
    7 / 637 (1.10%)
         occurrences all number
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 637 (2.35%)
         occurrences all number
    15
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    13 / 637 (2.04%)
         occurrences all number
    13
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    31 / 637 (4.87%)
         occurrences all number
    31
    Cardiac disorders
    Heart Problems
         subjects affected / exposed
    37 / 637 (5.81%)
         occurrences all number
    37
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 637 (1.57%)
         occurrences all number
    10
    Neuropathy
         subjects affected / exposed
    22 / 637 (3.45%)
         occurrences all number
    22
    General disorders and administration site conditions
    Alopecia
         subjects affected / exposed
    13 / 637 (2.04%)
         occurrences all number
    13
    Appetite disorder
         subjects affected / exposed
    20 / 637 (3.14%)
         occurrences all number
    20
    Fatigue
         subjects affected / exposed
    117 / 637 (18.37%)
         occurrences all number
    117
    Pyrexia
         subjects affected / exposed
    29 / 637 (4.55%)
         occurrences all number
    29
    Pain
         subjects affected / exposed
    86 / 637 (13.50%)
         occurrences all number
    86
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    44 / 637 (6.91%)
         occurrences all number
    44
    Neutropenia
         subjects affected / exposed
    91 / 637 (14.29%)
         occurrences all number
    91
    Platelet count decreased
         subjects affected / exposed
    24 / 637 (3.77%)
         occurrences all number
    24
    White blood cell count decreased
         subjects affected / exposed
    31 / 637 (4.87%)
         occurrences all number
    31
    Immune system disorders
    Anaphylaxis
         subjects affected / exposed
    10 / 637 (1.57%)
         occurrences all number
    10
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    11 / 637 (1.73%)
         occurrences all number
    11
    Diarrhoea
         subjects affected / exposed
    37 / 637 (5.81%)
         occurrences all number
    37
    Mucositis Oral
         subjects affected / exposed
    13 / 637 (2.04%)
         occurrences all number
    13
    Nausea
         subjects affected / exposed
    46 / 637 (7.22%)
         occurrences all number
    46
    Vomiting
         subjects affected / exposed
    45 / 637 (7.06%)
         occurrences all number
    45
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    30 / 637 (4.71%)
         occurrences all number
    30
    Cough
         subjects affected / exposed
    7 / 637 (1.10%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    80 / 637 (12.56%)
         occurrences all number
    80
    Pulmonary embolism
         subjects affected / exposed
    35 / 637 (5.49%)
         occurrences all number
    35
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 637 (0.78%)
         occurrences all number
    5
    Infections and infestations
    Infection
         subjects affected / exposed
    136 / 637 (21.35%)
         occurrences all number
    136
    Sepsis
         subjects affected / exposed
    7 / 637 (1.10%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    10 / 637 (1.57%)
         occurrences all number
    10
    Hypoalbuminaemia
         subjects affected / exposed
    8 / 637 (1.26%)
         occurrences all number
    8
    Hypokalaemia
         subjects affected / exposed
    7 / 637 (1.10%)
         occurrences all number
    7
    Hyponatraemia
         subjects affected / exposed
    19 / 637 (2.98%)
         occurrences all number
    19

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2008
    Changes to protocol: - Changes to members of the TMG - Clarification that assessments should be made in relation to trial registration not trial randomisation - Pre-chemotherapy blood requirements modified in line with drug modification guidelines - List of trial CRFs modified to include Adverse Event Form
    29 Apr 2009
    Changes to protocol, patient information sheet, consent form, gp letter and patient cards: - Addition of two new treatment arms for squamous patients (gemcitabine/cisplatin and gemcitabine/paclitaxel) - Amendments to the rationale of the trial as well as inclusion of rationale for including new treatment arms for squamous group - Gemcitabine/Cisplatin and Gemcitabine/Paclitaxel chemotherapy regimens added - All dose modification tables amended according to guidelines on SmPC for Pemetrexed and new dose modification tables added for Gemcitabine doublets - Statistical considerations section updated to include data on Gemcitabine/Cisplatin and Gemcitabine/Paclitaxel in squamous patients - Inclusion of 4 new references Addition of uncommon adverse events listed in Appendix 7 from the updated SmPC for Pemetrexed and the SmPC for Gemcitabine - Biological trial summary updated to include testing for resistance to gemcitabine - Addition of excluding patients who have recently received a yellow fever vaccination - Changes to patient information sheet, consent form, gp letter and patient cards to reflect new trial design
    19 Aug 2009
    Changes to the protocol, patient information sheet and consent form: - Platelet count for inclusion in the trial changed to >100x 109/L - Changes to the stratification factors for randomisation - Dose modification tables have been amended according to guidelines in the SmPC for Pemetrexed and Gemcitabine - The number of x-rays required for the trial has been reduced, i.e. at chemotherapy cycles 1, 3 and 5, as is standard practice in several centres. Having x-rays at cycles 2, 4 and 6 is now optional. - Adequate renal function is now defined as >60ml/min by EDTA or C&G. - Common toxicology criteria for adverse events (CTCAE) version 3.0 is now replaced by CTCAE version 4.0 - Clarification in the patient information sheet on what treatment non-squamous patients will receive inc. administration of vitamin B12 injections.
    09 Mar 2010
    Amendment to protocol, patient information sheet and consent form: • Addition of 24 hour urine collection as a method of determining patient GFR value • Clarification of two exclusion criteria’s which apply to non-squamous patients only • Clarification that all trial drugs can be dose banded • Clarification that vitamin b12 and folic acid should be started 7 days before trial treatment • Addition of dose modifications for Gemcitabine arms of the trial in the presence of febrile neutropenia • Pharmacovigilance section of the protocol updated to reflect the CTC template protocol • Removal of choice to do PET-CT scanning rather than CT scanning • Maximum number of hours for fixation of patient tissue samples amended from 48 to 72
    28 Oct 2010
    Amendment to labels for all IMPs and NIMPs.
    06 Apr 2011
    Amendment to protocol, patient information sheet, pregnancy monitoring information sheet and consent form: • Further clarification of the end of trial timepoint • Section added clarifying trial activation process for sponsor • Guidance added to inclusion criteria regarding contraception and to exclusion criteria regarding renal function • Documents to be given to randomised patients added • Terminology revised in Pharmacovigilance section • Updated information in relation to SAE processing at the UCL CTC and clinical reviewing • Addition of a section covering incident reporting and serious breaches • Addition of a section covering trial monitoring and oversight • Addition of a section covering withdrawal of patients • Addition of a section covering trial closure • Clarifying which patient identifiable information will be collected by the UCL CTC • Patient information sheet updated with advice on pregnancy and contraception
    26 Jul 2011
    Amendment to protocol: • Inclusion criteria amendment: Previous palliative radiotherapy to non-target lesions is allowed for pain relief prior to starting chemotherapy (in version 8.0 and previous protocol versions it could not be given in the 28 days prior to starting chemotherapy) • Addition that tumour samples obtained by EBUS cores and EBUS FNA cell blocks are allowed provided that the tumour cells are well preserved • Clarifications to wording to section 5.0 – Pharmacovigilance • Section 5.6 rewritten to refer to DSURs instead of ASRs • Update to pemetrexed secondary label and addition of a primary label
    03 Oct 2012
    Amendment to protocol, PIS, consent form, GP letter and patient card in line with Urgent Safety Measure undertaken 07/09/2012: • Protocol: clarification EBUS FNA and FNA are examples of cytology; the following amended for consistency across protocol: provision of prescription to CTC prior to site activation and use of ALT or AST in incl/excl; procedure for reporting temp excursions added; update to DM section; insurance section clarified to reflect it is insurers decision to compensate and not UCL; list of expected AEs added for pem/cis and pem/pac. • PIS: ERCC1 amended to provide clarity and easier understanding for patients; duration of treatment corrected from 3 months to 4.5months; removal of AEs associated with gemcitabine; number of CTs corrected in section entitled ‘Risk associated with the CT scan’. The risk factor is correct for 4 scans; wording updated to reflect pem/cisp is now licensed for first line treatment; insurance section updated in line with above protocol change. • Consent form: updated to reflect the change in version of the PIS • GP letter: correction to GP letter to indicate a new biopsy is not required for participation in the trial • Label Change for Pemetrexed: removal of primary label. Commercial stock to be over labelled for the outer packaging only. The outer and inner package will stay together at all times.
    16 Oct 2014
    Submission of results summary for patients and results summary cover letter for PI's.

    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.
    Trial stopped early in July 2013. Patients with squamous histology were excluded from September 2012. Only grade 3, 4 and 5 adverse events recorded. Relatedness of adverse events refers to number of patients not number of occurrences.
    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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