ID

35143

Descrição

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT02208843

Link

https://clinicaltrials.gov/show/NCT02208843

Palavras-chave

Versões (1)
  1. 19/02/2019 19/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02208843

Inglês

Eligibility Carcinoma, Non-Small-Cell Lung NCT02208843

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically confirmed diagnosis of stage iiib (with cytologically proven pleural effusion or pericardial effusion) or stage iv adenocarcinoma of the lung. patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
Descrição

Adenocarcinoma of lung TNM clinical staging | Pleural effusion | Pericardial effusion | Histology Mixed allowed | Adenocarcinoma Histology Predominant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0152013
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0031039
UMLS CUI [4,1]
C0344441
UMLS CUI [4,2]
C0205430
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0001418
UMLS CUI [5,2]
C0344441
UMLS CUI [5,3]
C1542147
2. documented egfr mutation (l858r and/or deletion 19) with no other known egfr mutation.
Descrição

EGFR L858R mutation | EGFR Exon 19 Deletion Mutation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274204
UMLS CUI [2]
C4289657
3. measureable disease according to recist 1.1.
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
4. radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
Descrição

Disease Progression Radiology | Recurrent disease Radiology | Status post First line treatment | Status post Chemotherapy Regimen Platinum-Based

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0043299
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0043299
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1708063
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C1514162
5. eastern cooperative oncology group (ecog) performance score of 0 or 1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate organ function.
Descrição

Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. more than one line of prior therapy for disease.
Descrição

Prior Therapy Quantity Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0012634
2. previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
Descrição

Chemotherapy cycle Platinum-Based Quantity | Etiology Toxicity | Etiology Intolerance Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0600688
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0231199
UMLS CUI [3,3]
C0087111
3. previous treatment with any egfr targeting tyrosine kinase inhibitor (tki) or antibody.
Descrição

EGFR Targeting Tyrosine kinase inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C1268567
4. known pre-existing interstitial lung disease.
Descrição

Interstitial Lung Disease Pre-existing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02208843

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of lung TNM clinical staging | Pleural effusion | Pericardial effusion | Histology Mixed allowed | Adenocarcinoma Histology Predominant
Item
1. pathologically confirmed diagnosis of stage iiib (with cytologically proven pleural effusion or pericardial effusion) or stage iv adenocarcinoma of the lung. patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
boolean
C0152013 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0344441 (UMLS CUI [4,1])
C0205430 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0001418 (UMLS CUI [5,1])
C0344441 (UMLS CUI [5,2])
C1542147 (UMLS CUI [5,3])
EGFR L858R mutation | EGFR Exon 19 Deletion Mutation
Item
2. documented egfr mutation (l858r and/or deletion 19) with no other known egfr mutation.
boolean
C3274204 (UMLS CUI [1])
C4289657 (UMLS CUI [2])
Measurable Disease
Item
3. measureable disease according to recist 1.1.
boolean
C1513041 (UMLS CUI [1])
Disease Progression Radiology | Recurrent disease Radiology | Status post First line treatment | Status post Chemotherapy Regimen Platinum-Based
Item
4. radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
boolean
C0242656 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C1514162 (UMLS CUI [4,3])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
6. adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Quantity Disease
Item
1. more than one line of prior therapy for disease.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Chemotherapy cycle Platinum-Based Quantity | Etiology Toxicity | Etiology Intolerance Therapy
Item
2. previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
boolean
C1302181 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0231199 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
EGFR Targeting Tyrosine kinase inhibitor
Item
3. previous treatment with any egfr targeting tyrosine kinase inhibitor (tki) or antibody.
boolean
C0034802 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C1268567 (UMLS CUI [1,3])
Interstitial Lung Disease Pre-existing
Item
4. known pre-existing interstitial lung disease.
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
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