ID

35850

Description

Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02206763

Link

https://clinicaltrials.gov/show/NCT02206763

Keywords

Versions (1)
  1. 3/27/19 3/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

English

Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic nsclc with documented egfr exon 19 deletion or exon 21 (l858r) substitution mutation
Description

Non-small cell lung cancer metastatic | EGFR Exon 19 Deletion Mutation | EGFR Exon 21 L858R Mutation

Data type

boolean

Alias
UMLS CUI [1]
C0278987
UMLS CUI [2]
C4289657
UMLS CUI [3]
C3274204
treatment naive or one prior standard chemotherapy that is platinum-based
Description

Therapy naive | Prior Chemotherapy Platinum-Based Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C1265611
adequate organ function defined as follows:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
hepatic: total bilirubin < upper limit of the normal range (uln); aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
hematological: absolute neutrophil count (anc) ≥1500 cells/mm^3, platelet ≥
Description

Hematologic function | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
renal: serum creatinine < uln or calculated creatinine clearance (crcl) of ≥ 60 ml/min
Description

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known positive status for human immunodeficiency virus (hiv)
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c)
Description

Chronic type A viral hepatitis | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis A | Hepatitis B | Hepatitis C | Testing Hepatitis B | Testing Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0276435
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
UMLS CUI [4]
C0019159
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
UMLS CUI [7,1]
C0039593
UMLS CUI [7,2]
C0019163
UMLS CUI [8,1]
C0039593
UMLS CUI [8,2]
C0019196
presence of > grade 1 peripheral neuropathy
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
symptomatic leptomeningeal, brain metastases, or spinal cord compression.
Description

Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Metastatic malignant neoplasm to brain Symptomatic | Compression of spinal cord Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1704231
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0037926
UMLS CUI [3,2]
C0231220
history of interstitial pneumonitis
Description

Pneumonia, Interstitial

Data type

boolean

Alias
UMLS CUI [1]
C0206061
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Similar models

Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer metastatic | EGFR Exon 19 Deletion Mutation | EGFR Exon 21 L858R Mutation
Item
metastatic nsclc with documented egfr exon 19 deletion or exon 21 (l858r) substitution mutation
boolean
C0278987 (UMLS CUI [1])
C4289657 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
Therapy naive | Prior Chemotherapy Platinum-Based Quantity
Item
treatment naive or one prior standard chemotherapy that is platinum-based
boolean
C0919936 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Organ function
Item
adequate organ function defined as follows:
boolean
C0678852 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic: total bilirubin < upper limit of the normal range (uln); aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Hematologic function | Absolute neutrophil count | Platelet Count measurement
Item
hematological: absolute neutrophil count (anc) ≥1500 cells/mm^3, platelet ≥
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement
Item
100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal: serum creatinine < uln or calculated creatinine clearance (crcl) of ≥ 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity
Item
known positive status for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Chronic type A viral hepatitis | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis A | Hepatitis B | Hepatitis C | Testing Hepatitis B | Testing Hepatitis C
Item
chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c)
boolean
C0276435 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0019159 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
C0039593 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0039593 (UMLS CUI [8,1])
C0019196 (UMLS CUI [8,2])
Peripheral Neuropathy CTCAE Grades
Item
presence of > grade 1 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Metastatic malignant neoplasm to brain Symptomatic | Compression of spinal cord Symptomatic
Item
symptomatic leptomeningeal, brain metastases, or spinal cord compression.
boolean
C1704231 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0037926 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Pneumonia, Interstitial
Item
history of interstitial pneumonitis
boolean
C0206061 (UMLS CUI [1])
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