ID

36404

Descrição

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02411448

Link

https://clinicaltrials.gov/show/NCT02411448

Palavras-chave

Versões (1)
  1. 11/05/2019 11/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Non-Small Cell Lung Cancer NCT02411448

Inglês

Eligibility Metastatic Non-Small Cell Lung Cancer NCT02411448

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytologically or histologically confirmed diagnosis of stage iv nsclc as defined by the american joint committee on cancer staging criteria for lung cancer (ajcc 7th edition 2009).
Descrição

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating egfr mutation (example 19 del and l858r).
Descrição

Eligibility First line treatment Erlotinib | Neoplasm EGFR Activating Mutation | Loss of Chromosome 19 | EGFR Activating Mutation L858R

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C1135135
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2984891
UMLS CUI [3]
C1517970
UMLS CUI [4]
C3274204
mandatory provision of adequate archived stage iv nsclc tissue sample.
Descrição

Non-Small Cell Lung Carcinoma Tissue specimen TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1292533
UMLS CUI [1,3]
C3258246
at least one measurable lesion.
Descrição

Measurable lesion Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
life expectancy of at least 3 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known t790m egfr mutation.
Descrição

EGFR T790M

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274192
known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
Descrição

Meningeal Carcinomatosis Uncontrolled | Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220654
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0037926
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0220650
serious illness or medical condition.
Descrição

Illness Serious | Medical condition Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
ongoing treatment with cyp3a4 inducers or strong/moderate inhibitors.
Descrição

CYP3A4 Inducers | CYP3A4 Inhibitors Strong | CYP3A4 Inhibitors Moderate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3850053
UMLS CUI [3,2]
C0205081
ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
Descrição

Anti-Inflammatory Agents, Non-Steroidal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003211
history of gross hemoptysis.
Descrição

Hemoptysis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C0205082
significant bleeding disorders.
Descrição

Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
radiologically documented evidence of major blood vessel invasion or encasement by cancer.
Descrição

Tumor Invasion Blood Vessel Major

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0205164
radiographic evidence of intratumor cavitation.
Descrição

Tumour cavitation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4524108
history of gastrointestinal perforation within last 6 months.
Descrição

Gastrointestinal perforation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151664
history of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
Descrição

Intestinal Obstruction | Intestinal Disease inflammatory | Intestinal resection Extensive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021843
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0333348
UMLS CUI [3,1]
C1096244
UMLS CUI [3,2]
C0205231
history of any arterial thrombotic event within 6 months prior to enrollment.
Descrição

Arterial thrombosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151942
the participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Descrição

Abnormality Surface of eye

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C4321570
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Similar models

Eligibility Metastatic Non-Small Cell Lung Cancer NCT02411448

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
cytologically or histologically confirmed diagnosis of stage iv nsclc as defined by the american joint committee on cancer staging criteria for lung cancer (ajcc 7th edition 2009).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Eligibility First line treatment Erlotinib | Neoplasm EGFR Activating Mutation | Loss of Chromosome 19 | EGFR Activating Mutation L858R
Item
eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating egfr mutation (example 19 del and l858r).
boolean
C1548635 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C1135135 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2984891 (UMLS CUI [2,2])
C1517970 (UMLS CUI [3])
C3274204 (UMLS CUI [4])
Non-Small Cell Lung Carcinoma Tissue specimen TNM clinical staging
Item
mandatory provision of adequate archived stage iv nsclc tissue sample.
boolean
C0007131 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Measurable lesion Quantity
Item
at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
EGFR T790M
Item
known t790m egfr mutation.
boolean
C3274192 (UMLS CUI [1])
Meningeal Carcinomatosis Uncontrolled | Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain
Item
known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
boolean
C0220654 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0037926 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3])
Illness Serious | Medical condition Serious
Item
serious illness or medical condition.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
CYP3A4 Inducers | CYP3A4 Inhibitors Strong | CYP3A4 Inhibitors Moderate
Item
ongoing treatment with cyp3a4 inducers or strong/moderate inhibitors.
boolean
C3850041 (UMLS CUI [1])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3850053 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Anti-Inflammatory Agents, Non-Steroidal
Item
ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
boolean
C0003211 (UMLS CUI [1])
Hemoptysis Severe
Item
history of gross hemoptysis.
boolean
C0019079 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Blood Coagulation Disorders
Item
significant bleeding disorders.
boolean
C0005779 (UMLS CUI [1])
Tumor Invasion Blood Vessel Major
Item
radiologically documented evidence of major blood vessel invasion or encasement by cancer.
boolean
C1269955 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Tumour cavitation
Item
radiographic evidence of intratumor cavitation.
boolean
C4524108 (UMLS CUI [1])
Gastrointestinal perforation
Item
history of gastrointestinal perforation within last 6 months.
boolean
C0151664 (UMLS CUI [1])
Intestinal Obstruction | Intestinal Disease inflammatory | Intestinal resection Extensive
Item
history of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
boolean
C0021843 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C1096244 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
Arterial thrombosis
Item
history of any arterial thrombotic event within 6 months prior to enrollment.
boolean
C0151942 (UMLS CUI [1])
Abnormality Surface of eye
Item
the participant has any known significant ophthalmologic abnormalities of the surface of the eye.
boolean
C1704258 (UMLS CUI [1,1])
C4321570 (UMLS CUI [1,2])
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