ID

36667

Descripción

Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02454842

Link

https://clinicaltrials.gov/show/NCT02454842

Palabras clave

Versiones (1)
  1. 31/5/19 31/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

31 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02454842

Inglés

Eligibility Non-small Cell Lung Cancer NCT02454842

1 formularios  
Criteria
Descripción

Criteria

eastern cooperative oncology group (ecog) performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
confirmed recurrent stage iv nsclc which progressed while on treatment with egfr tki
Descripción

Non-small cell lung cancer recurrent TNM clinical staging | Disease Progression | EGFR TKI Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C0087111
measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
documented evidence of an egfr mutation known to be associated with an egfr tki sensitivity
Descripción

EGFR mutation Associated with Sensitivity EGFR TKI

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C1443775
no history of exon 20 t790m mutation or small cell transformation including an assessment from tumor biopsy obtained while on the most recent egfr tki therapy
Descripción

EGFR gene exon 20 T790M Mutation Negative | Small Cell Lung Carcinoma Transformation Absent | Tumor Biopsy Assessment | EGFR TKI Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2736992
UMLS CUI [1,2]
C4329762
UMLS CUI [2,1]
C4526833
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0005558
UMLS CUI [3,3]
C1516048
UMLS CUI [4,1]
C1443775
UMLS CUI [4,2]
C0087111
no intervening systemic therapy between the end of egfr tki treatment and dosing with study drug
Descripción

Absence Systemic therapy Interventional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C0184661
acceptable laboratory results as indicated by protocol
Descripción

Laboratory Results Consistent with Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
acceptable cardiac function as indicated by protocol
Descripción

Cardiac function Consistent with Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
key exclusion criteria:
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
receiving medication that prolongs qt interval, with a risk of causing torsades de pointes (tdp) unless ecg meets inclusion criteria while on a stable dose of the medication
Descripción

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Torsades de Pointes | Exception ECG meet Inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0040479
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013798
UMLS CUI [3,3]
C1550543
UMLS CUI [3,4]
C1512693
family history of long qtc syndrome
Descripción

Family history of long QT syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3839836
any prior t790m mutation
Descripción

EGFR T790M Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C0026882
symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
Descripción

Central nervous system lesion Symptomatic | Treatment required for Central nervous system lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0742468
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0742468
radiation therapy within 2 weeks prior to the first dose of study medication
Descripción

Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
Descripción

Major surgery | Minor Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0038904
concurrent active malignancy requiring systemic treatment
Descripción

Cancer Other Requirement Systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
Descripción

Disease Serious Uncontrolled | Mental condition Serious Uncontrolled | Interference Completion of clinical trial | Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C2732579
UMLS CUI [4]
C0009450
pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02454842

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Non-small cell lung cancer recurrent TNM clinical staging | Disease Progression | EGFR TKI Therapy
Item
confirmed recurrent stage iv nsclc which progressed while on treatment with egfr tki
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C1443775 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
boolean
C1513041 (UMLS CUI [1])
EGFR mutation Associated with Sensitivity EGFR TKI
Item
documented evidence of an egfr mutation known to be associated with an egfr tki sensitivity
boolean
C3266992 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C1443775 (UMLS CUI [1,4])
EGFR gene exon 20 T790M Mutation Negative | Small Cell Lung Carcinoma Transformation Absent | Tumor Biopsy Assessment | EGFR TKI Therapy
Item
no history of exon 20 t790m mutation or small cell transformation including an assessment from tumor biopsy obtained while on the most recent egfr tki therapy
boolean
C2736992 (UMLS CUI [1,1])
C4329762 (UMLS CUI [1,2])
C4526833 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C1443775 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
Absence Systemic therapy Interventional
Item
no intervening systemic therapy between the end of egfr tki treatment and dosing with study drug
boolean
C0332197 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Laboratory Results Consistent with Study Protocol
Item
acceptable laboratory results as indicated by protocol
boolean
C1254595 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Cardiac function Consistent with Study Protocol
Item
acceptable cardiac function as indicated by protocol
boolean
C0232164 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Torsades de Pointes | Exception ECG meet Inclusion criteria
Item
receiving medication that prolongs qt interval, with a risk of causing torsades de pointes (tdp) unless ecg meets inclusion criteria while on a stable dose of the medication
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C1512693 (UMLS CUI [3,4])
Family history of long QT syndrome
Item
family history of long qtc syndrome
boolean
C3839836 (UMLS CUI [1])
EGFR T790M Mutation
Item
any prior t790m mutation
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
Central nervous system lesion Symptomatic | Treatment required for Central nervous system lesion
Item
symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
boolean
C0742468 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0742468 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks prior to the first dose of study medication
boolean
C1522449 (UMLS CUI [1])
Major surgery | Minor Surgical Procedures
Item
major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
boolean
C0679637 (UMLS CUI [1])
C0038904 (UMLS CUI [2])
Cancer Other Requirement Systemic therapy
Item
concurrent active malignancy requiring systemic treatment
boolean
C1707251 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Disease Serious Uncontrolled | Mental condition Serious Uncontrolled | Interference Completion of clinical trial | Communicable Disease
Item
any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C2732579 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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