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ID

12125

Description

Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02109653

Link

https://clinicaltrials.gov/show/NCT02109653

Keywords

  1. 9/28/15 9/28/15 - Julian Varghese
  2. 4/9/21 4/9/21 - Ahmed Rafee, MD
Uploaded on

September 28, 2015

DOI

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License

Creative Commons BY 4.0

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    Eligibility Non-Small Cell Lung Cancer NCT02109653

    Eligibility Non-Small Cell Lung Cancer NCT02109653

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    presence of braf v600e mutation in tumor tissue
    Description

    v600e mutation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3811884
    histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
    Description

    stage iiib or iv nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278984
    UMLS CUI [2]
    C0278987
    at least one measurable lesion as defined by recist v1.1
    Description

    measurable lesion as defined by recist

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1513040
    UMLS CUI [1,3]
    C1709926
    patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
    Description

    systemic, anti-cancer treatment; advanced or metastatic nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C0920425
    eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
    Description

    eastern cooperative oncology group; performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with symptomatic central nervous system (cns) metastases
    Description

    symptomatic central nervous system involvement; metastases; cns

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0686377
    UMLS CUI [1,2]
    C0231220
    history of leptomeningeal metastases
    Description

    leptomeningeal metastases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704231
    prior therapy with a braf inhibitor
    Description

    prior therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3838813
    patients taking prohibited medication listed in the protocol
    Description

    medication; protocol

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
    Description

    malignant disease other than nsclc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    impaired cardiovascular function or clinically significant cardiovascular diseases
    Description

    significant cardiovascular diseases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205082
    pregnant or lactating women or woman of childbearing potential
    Description

    pregnant or lactating women of childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0549206
    UMLS CUI [1,2]
    |C2828358|C3831118

    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT02109653

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    v600e mutation
    Item
    presence of braf v600e mutation in tumor tissue
    boolean
    C3811884 (UMLS CUI [1])
    stage iiib or iv nsclc
    Item
    histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc
    boolean
    C0278984 (UMLS CUI [1])
    C0278987 (UMLS CUI [2])
    measurable lesion as defined by recist
    Item
    at least one measurable lesion as defined by recist v1.1
    boolean
    C0221198 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    C1709926 (UMLS CUI [1,3])
    systemic, anti-cancer treatment; advanced or metastatic nsclc
    Item
    patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc.
    boolean
    C1515119 (UMLS CUI [1,1])
    C0920425 (UMLS CUI [1,2])
    eastern cooperative oncology group; performance status
    Item
    eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    symptomatic central nervous system involvement; metastases; cns
    Item
    patients with symptomatic central nervous system (cns) metastases
    boolean
    C0686377 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    leptomeningeal metastases
    Item
    history of leptomeningeal metastases
    boolean
    C1704231 (UMLS CUI [1])
    prior therapy
    Item
    prior therapy with a braf inhibitor
    boolean
    C3838813 (UMLS CUI [1])
    medication; protocol
    Item
    patients taking prohibited medication listed in the protocol
    boolean
    C0525058 (UMLS CUI [1])
    malignant disease other than nsclc
    Item
    presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years.
    boolean
    C0006826 (UMLS CUI [1])
    significant cardiovascular diseases
    Item
    impaired cardiovascular function or clinically significant cardiovascular diseases
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    pregnant or lactating women of childbearing potential
    Item
    pregnant or lactating women or woman of childbearing potential
    boolean
    C0549206 (UMLS CUI [1,1])
    |C2828358|C3831118 (UMLS CUI [1,2])

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