ID

36606

Descripción

Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02064491

Link

https://clinicaltrials.gov/show/NCT02064491

Palabras clave

Versiones (1)
  1. 26/5/19 26/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 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 NCT02064491

Inglés

Eligibility Non-small Cell Lung Cancer NCT02064491

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage iiib/iv nsclc.
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
investigator confirmed progression according recist 1.1 during egfr tki treatment within 28 days of the randomization
Descripción

Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0872291
UMLS CUI [2]
C1443775
activating mutation (g719a/c/s; exon 19 insertion/deletion; l858r; l861q) in the egfr gene or have had at least partial response with egfr tki lasting ≥ 6 months
Descripción

EGFR Activating Mutation | EGFR G719A | EGFR G719C | EGFR G719S | EGFR Exon 19 Insertion | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | Partial response EGFR Tyrosine Kinase inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2984891
UMLS CUI [2]
C3274209
UMLS CUI [3]
C3274211
UMLS CUI [4]
C3274216
UMLS CUI [5]
C4525161
UMLS CUI [6]
C3889117
UMLS CUI [7]
C3274204
UMLS CUI [8]
C3274186
UMLS CUI [9,1]
C1521726
UMLS CUI [9,2]
C1443775
performance status: who 0-2
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
measurable disease according to recist 1.1
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
patients must be able to comply with study treatments
Descripción

Compliance behavior Investigational Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0949266
women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
Descripción

Females & males of reproductive potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
neutrophils ≥ 1'000/μl, platelets ≥ 100'000/μl, alanine amino transferase ≤ 2.5 ×
Descripción

Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
upper limit of normal (uln) (< 5 × uln if liver metastases), alkaline phosphatase ≤
Descripción

Alkaline phosphatase measurement | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0494165
2.5 × uln (< 5 × uln if liver metastases), serum bilirubin ≤ 1.5 × uln, serum creatinine ≤ 1.5 × uln.
Descripción

Serum total bilirubin measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
patient must be able to comply with the protocol
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
recist 1.1 defined disease progression for more than 28 days while on previous egfr tki treatment.
Descripción

Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0872291
UMLS CUI [2]
C1443775
patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
Descripción

Hypersensitivity Erlotinib | Intolerance to Erlotinib | Hypersensitivity Gefitinib | Intolerance to Gefitinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1135135
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1122962
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1122962
patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
Descripción

Hypersensitivity Antineoplastic Agents | Intolerance to Antineoplastic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003392
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003392
patient with symptomatic central nervous system metastases
Descripción

CNS metastases Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
patient has known active hepatitis b or c, or hiv infection
Descripción

Hepatitis B | Hepatitis C | HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
pregnant or breastfeeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Descripción

Comorbidity Uncontrolled Limiting Protocol Compliance | Circumstances Limiting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0680082
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02064491

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically confirmed stage iiib/iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors
Item
investigator confirmed progression according recist 1.1 during egfr tki treatment within 28 days of the randomization
boolean
C0242656 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
EGFR Activating Mutation | EGFR G719A | EGFR G719C | EGFR G719S | EGFR Exon 19 Insertion | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | Partial response EGFR Tyrosine Kinase inhibitors
Item
activating mutation (g719a/c/s; exon 19 insertion/deletion; l858r; l861q) in the egfr gene or have had at least partial response with egfr tki lasting ≥ 6 months
boolean
C2984891 (UMLS CUI [1])
C3274209 (UMLS CUI [2])
C3274211 (UMLS CUI [3])
C3274216 (UMLS CUI [4])
C4525161 (UMLS CUI [5])
C3889117 (UMLS CUI [6])
C3274204 (UMLS CUI [7])
C3274186 (UMLS CUI [8])
C1521726 (UMLS CUI [9,1])
C1443775 (UMLS CUI [9,2])
Performance status
Item
performance status: who 0-2
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist 1.1
boolean
C1513041 (UMLS CUI [1])
Compliance behavior Investigational Therapy
Item
patients must be able to comply with study treatments
boolean
C1321605 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Neutrophil count | Platelet Count measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
neutrophils ≥ 1'000/μl, platelets ≥ 100'000/μl, alanine amino transferase ≤ 2.5 ×
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Alkaline phosphatase measurement | Secondary malignant neoplasm of liver
Item
upper limit of normal (uln) (< 5 × uln if liver metastases), alkaline phosphatase ≤
boolean
C0201850 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Serum total bilirubin measurement | Creatinine measurement, serum
Item
2.5 × uln (< 5 × uln if liver metastases), serum bilirubin ≤ 1.5 × uln, serum creatinine ≤ 1.5 × uln.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Protocol Compliance
Item
patient must be able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Progression Timespan | EGFR Tyrosine Kinase inhibitors
Item
recist 1.1 defined disease progression for more than 28 days while on previous egfr tki treatment.
boolean
C0242656 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
Investigational New Drugs
Item
patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Erlotinib | Intolerance to Erlotinib | Hypersensitivity Gefitinib | Intolerance to Gefitinib
Item
patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1135135 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1122962 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C1122962 (UMLS CUI [4,2])
Hypersensitivity Antineoplastic Agents | Intolerance to Antineoplastic Agents
Item
patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
boolean
C0020517 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003392 (UMLS CUI [2,2])
CNS metastases Symptomatic
Item
patient with symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
patient has known active hepatitis b or c, or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled Limiting Protocol Compliance | Circumstances Limiting Protocol Compliance
Item
patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0680082 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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