Non-Small Cell Lung Carcinoma Advanced
Item
diagnosis of advanced malignancy, non-small cell lung cancer (nsclc) only during stage 1 of accrual
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Missense Mutation BRAF gene | Missense Mutation DDR2 gene
Item
non-synonymous mutation of b-raf or ddr2, defined as follows:
boolean
C0599155 (UMLS CUI [1,1])
C0812241 (UMLS CUI [1,2])
C0599155 (UMLS CUI [2,1])
C1333207 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | Inactivation BRAF gene mutation
Item
nsclc with inactivating b-raf mutation
boolean
C0007131 (UMLS CUI [1])
C0598496 (UMLS CUI [2,1])
C1511021 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | DDR2 gene Mutation
Item
nsclc with ddr2 mutation
boolean
C0007131 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
Cancer Other | DDR2 gene Mutation | Inactivation BRAF gene mutation
Item
malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation which is not functionally characterized
boolean
C1707251 (UMLS CUI [1])
C1333207 (UMLS CUI [2,1])
C0596611 (UMLS CUI [2,2])
C0598496 (UMLS CUI [3,1])
C1511021 (UMLS CUI [3,2])
Target Lesion Quantity
Item
at least one target lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria on baseline staging evaluation
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Disease Progression | Status post Prior Therapy Quantity
Item
disease progression after ≥ 1 prior treatment regimen
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Exception First line treatment Squamous non-small cell lung cancer | Exception First line treatment DDR2 gene Mutation
Item
exception: subjects with nsclc of squamous type and ddr2 mutation may be enrolled in first line, no prior treatment is required
boolean
C1705847 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C4509816 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1333207 (UMLS CUI [2,3])
C0596611 (UMLS CUI [2,4])
Pleural effusion CTCAE Grades | Pericardial effusion CTCAE Grades
Item
pleural or pericardial effusion grade > 1
boolean
C0032227 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031039 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
QTcF Prolongation | Congenital long QT syndrome
Item
qtcf > 470 msec (grade ≥ 2) or diagnosed congenital long qt syndrome
boolean
C3828431 (UMLS CUI [1])
C1141890 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute granulocyte count < 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum calcium decreased
Item
serum calcium < institutional lower limit of normal (lln)
boolean
C0595882 (UMLS CUI [1])
Hypokalemia Grade | Hypophosphatemia Grade | Hypomagnesemia Grade | Supplementation Inefficient
Item
hypokalemia, hypophosphatemia or hypomagnesemia grade > 1, despite supplementation
boolean
C0020621 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0085682 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0151723 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0242297 (UMLS CUI [4,1])
C0231185 (UMLS CUI [4,2])
Serum creatinine raised
Item
creatinine > 3 x institutional upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine transaminase (alt) > 3 x uln
boolean
C0151905 (UMLS CUI [1])