ID

14630

Beskrivning

A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02297425

Länk

https://clinicaltrials.gov/show/NCT02297425

Nyckelord

  1. 2016-04-24 2016-04-24 -
Uppladdad den

24 april 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC NCT02297425

Eligibility Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC NCT02297425

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that is resistant to standard therapy. patients must have progressed on treatment with an egfr tki, and may have also received other line of therapy.
Beskrivning

EGFR

Datatyp

boolean

Alias
UMLS CUI [1]
C0034802
tissue available (formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron)
Beskrivning

tissue available

Datatyp

boolean

Alias
UMLS CUI [1]
C2711483
patients must be willing to participate in additional pk studies as required (cohort dependent); patients will be informed of which pk studies are required prior to consenting for study participation
Beskrivning

additional pk studies

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
adequate bone marrow function (complete blood count laboratory test results)
Beskrivning

bone marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0005953
adequate liver function (laboratory test)
Beskrivning

liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable
Beskrivning

brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
systemic anti-cancer therapy within 4 weeks of starting study treatment excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 days prior to starting study drug
Beskrivning

systemic anti-cancer therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
hypertension that cannot be controlled by medication (150/100 mmhg despite optimal medical therapy).
Beskrivning

hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538

Similar models

Eligibility Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC NCT02297425

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
EGFR
Item
evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that is resistant to standard therapy. patients must have progressed on treatment with an egfr tki, and may have also received other line of therapy.
boolean
C0034802 (UMLS CUI [1])
tissue available
Item
tissue available (formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron)
boolean
C2711483 (UMLS CUI [1])
additional pk studies
Item
patients must be willing to participate in additional pk studies as required (cohort dependent); patients will be informed of which pk studies are required prior to consenting for study participation
boolean
C2348568 (UMLS CUI [1])
bone marrow function
Item
adequate bone marrow function (complete blood count laboratory test results)
boolean
C0005953 (UMLS CUI [1])
liver function
Item
adequate liver function (laboratory test)
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastases
Item
previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable
boolean
C0220650 (UMLS CUI [1])
systemic anti-cancer therapy
Item
systemic anti-cancer therapy within 4 weeks of starting study treatment excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 days prior to starting study drug
boolean
C0392920 (UMLS CUI [1])
hypertension
Item
hypertension that cannot be controlled by medication (150/100 mmhg despite optimal medical therapy).
boolean
C0020538 (UMLS CUI [1])

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