ID

39256

Beschrijving

ARCHER-1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.; ODM derived from: https://clinicaltrials.gov/show/NCT01774721

Link

https://clinicaltrials.gov/show/NCT01774721

Trefwoorden

Versies (1)
  1. 13-12-19 13-12-19 -
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See clinicaltrials.gov

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13 december 2019

DOI

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Creative Commons BY 4.0
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Eligibility EGFR Positive Non-small Cell Lung Cancer NCT01774721

Engels

Eligibility EGFR Positive Non-small Cell Lung Cancer NCT01774721

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
evidence of histo or cytopathology confirmed, advanced nsclc (with known histology) with the presence of egfr activating mutation (exon 19 deletion or the l858r mutation in exon 21).
Beschrijving

Non-Small Cell Lung Carcinoma Advanced | EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C2984891
UMLS CUI [3]
C3889117
UMLS CUI [4]
C3888903
it is acceptable for subjects with the presence of the exon 20 t790m mutation together with either egfr activating mutation (exon 19 deletion or the l858r mutation in exon 21) to be included in this study
Beschrijving

EGFR Exon 20 Mutation | EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)

Datatype

boolean

Alias
UMLS CUI [1]
C4289655
UMLS CUI [2]
C2984891
UMLS CUI [3]
C3889117
UMLS CUI [4]
C3888903
minimum of 12 months disease free interval between completion of systemic therapy and recurrence of nsclc
Beschrijving

Systemic therapy Complete | Disease Free Duration | Non-small cell lung cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0449238
UMLS CUI [3]
C0278517
adequate tissue sample must be available for central analyses.
Beschrijving

Availability of Tissue specimen | Analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1292533
UMLS CUI [2]
C0002778
adequate renal, hematologic, liver function.
Beschrijving

Renal function | Hematologic function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232741
ecog ps of 0-1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
radiologically measurable disease.
Beschrijving

Measurable Disease Radiologic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205483
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
Beschrijving

Small cell carcinoma of lung | Carcinoid tumor of lung

Datatype

boolean

Alias
UMLS CUI [1]
C0149925
UMLS CUI [2]
C0280089
any other mutation other than exon 19 deletion or l858r in exon 21, with or without the presence of the exon 20 t790m mutation.
Beschrijving

Mutation | Exception EGFR exon 19 deletion | Exception Point mutation in exon 21 (L858R) | EGFR Exon 20 Mutation | EGFR Exon 20 Mutation Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0026882
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3889117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3888903
UMLS CUI [4]
C4289655
UMLS CUI [5,1]
C4289655
UMLS CUI [5,2]
C0332197
any history of brain mets or leptomeningeal mets.
Beschrijving

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
any previous anti-cancer systemic treatment of early, locally advanced, or metastatic nsclc.
Beschrijving

Systemic therapy Non-Small Cell Lung Carcinoma Early stage | Systemic therapy Non-Small Cell Lung Carcinoma Advanced Locally | Systemic therapy Non-small cell lung cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C2363430
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0205179
UMLS CUI [2,4]
C1517927
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0278987
uncontrolled medical disorders.
Beschrijving

Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility EGFR Positive Non-small Cell Lung Cancer NCT01774721

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced | EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)
Item
evidence of histo or cytopathology confirmed, advanced nsclc (with known histology) with the presence of egfr activating mutation (exon 19 deletion or the l858r mutation in exon 21).
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2984891 (UMLS CUI [2])
C3889117 (UMLS CUI [3])
C3888903 (UMLS CUI [4])
EGFR Exon 20 Mutation | EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)
Item
it is acceptable for subjects with the presence of the exon 20 t790m mutation together with either egfr activating mutation (exon 19 deletion or the l858r mutation in exon 21) to be included in this study
boolean
C4289655 (UMLS CUI [1])
C2984891 (UMLS CUI [2])
C3889117 (UMLS CUI [3])
C3888903 (UMLS CUI [4])
Systemic therapy Complete | Disease Free Duration | Non-small cell lung cancer recurrent
Item
minimum of 12 months disease free interval between completion of systemic therapy and recurrence of nsclc
boolean
C1515119 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3])
Availability of Tissue specimen | Analysis
Item
adequate tissue sample must be available for central analyses.
boolean
C0470187 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0002778 (UMLS CUI [2])
Renal function | Hematologic function | Liver function
Item
adequate renal, hematologic, liver function.
boolean
C0232804 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
ECOG performance status
Item
ecog ps of 0-1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Radiologic
Item
radiologically measurable disease.
boolean
C1513041 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of lung | Carcinoid tumor of lung
Item
any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
boolean
C0149925 (UMLS CUI [1])
C0280089 (UMLS CUI [2])
Mutation | Exception EGFR exon 19 deletion | Exception Point mutation in exon 21 (L858R) | EGFR Exon 20 Mutation | EGFR Exon 20 Mutation Absent
Item
any other mutation other than exon 19 deletion or l858r in exon 21, with or without the presence of the exon 20 t790m mutation.
boolean
C0026882 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3889117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3888903 (UMLS CUI [3,2])
C4289655 (UMLS CUI [4])
C4289655 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
any history of brain mets or leptomeningeal mets.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Systemic therapy Non-Small Cell Lung Carcinoma Early stage | Systemic therapy Non-Small Cell Lung Carcinoma Advanced Locally | Systemic therapy Non-small cell lung cancer metastatic
Item
any previous anti-cancer systemic treatment of early, locally advanced, or metastatic nsclc.
boolean
C1515119 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C2363430 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C1515119 (UMLS CUI [3,1])
C0278987 (UMLS CUI [3,2])
Disease Uncontrolled
Item
uncontrolled medical disorders.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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