ID

35143

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02208843

Nyckelord

Versioner (1)
  1. 2019-02-19 2019-02-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 februari 2019

DOI

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

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT02208843

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

EGFR L858R mutation | EGFR Exon 19 Deletion Mutation

Datatyp

boolean

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

Measurable Disease

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

ECOG performance status

Datatyp

boolean

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

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Prior Therapy Quantity Disease

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

EGFR Targeting Tyrosine kinase inhibitor

Datatyp

boolean

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

Interstitial Lung Disease Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
Tillbaka till toppen

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02208843

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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