ID

42098

Descripción

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

Palabras clave

Versiones (2)
  1. 28/9/15 28/9/15 - Julian Varghese
  2. 9/4/21 9/4/21 - Ahmed Rafee, MD
Titular de derechos de autor

AR

Subido en

9 de abril de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02109653

Inglés

Eligibility Non-Small Cell Lung Cancer NCT02109653

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

v600e mutation

Tipo de datos

boolean

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

stage iiib or iv nsclc

Tipo de datos

boolean

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

measurable lesion as defined by recist

Tipo de datos

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.
Descripción

systemic, anti-cancer treatment; advanced or metastatic nsclc

Tipo de datos

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
Descripción

eastern cooperative oncology group; performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

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

symptomatic central nervous system involvement; metastases; cns

Tipo de datos

boolean

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

leptomeningeal metastases

Tipo de datos

boolean

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

prior therapy

Tipo de datos

boolean

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

medication; protocol

Tipo de datos

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.
Descripción

malignant disease other than nsclc

Tipo de datos

boolean

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

significant cardiovascular diseases

Tipo de datos

boolean

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

pregnant or lactating women of childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
UMLS CUI [3]
C3831118
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02109653

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
C2828358 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
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