Confirmed by Pathology
Item
1. pathologically confirmed:
boolean
C0521093 (UMLS CUI [1,1])
C0919386 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | Adenocarcinoma of lung | Squamous cell carcinoma of lung
Item
non-small cell lung cancer (nsclc, adenocarcinoma or squamous-cell carcinoma) or
boolean
C0007131 (UMLS CUI [1])
C0152013 (UMLS CUI [2])
C0149782 (UMLS CUI [3])
HER2-positive carcinoma of breast | Triple Negative Breast Neoplasm
Item
breast cancer (her2 positive or triple negative) or
boolean
C1960398 (UMLS CUI [1])
C3539878 (UMLS CUI [2])
Pancreatic carcinoma | Adenocarcinoma of pancreas
Item
pancreatic cancer (adenocarcinoma)
boolean
C0235974 (UMLS CUI [1])
C0281361 (UMLS CUI [2])
Recurrent disease TNM clinical staging | Refractory Disease TNM clinical staging | Non-Small Cell Lung Carcinoma | Pancreatic carcinoma | Prior Therapy Quantity failed | Breast Carcinoma
Item
2. relapsed or refractory disease (stage iii or iv): nsclc or pancreatic cancer must have failed at least 1 prior treatment. breast cancer must have failed at least 2 prior treatments.
boolean
C0277556 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3])
C0235974 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0678222 (UMLS CUI [6])
Measurable lesion
Item
3. measurable lesion by recist 1.1
boolean
C1513041 (UMLS CUI [1])
Hematologic function
Item
4. adequate hematologic function:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
anc >1500 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >100,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb >9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Liver function | Renal function
Item
5. adequate hepatic and renal function:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver
Item
ast and alt ≤2.5 x uln for subjects without liver metastases and ≤3.5 x uln for subjects with liver metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0494165 (UMLS CUI [4])
Serum total bilirubin measurement | Exception Elevated total bilirubin Due to Gilbert Disease
Item
bilirubin ≤1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0741494 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017551 (UMLS CUI [2,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤2.0 x uln or creatinine clearance ≥40 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Prothrombin time assay | International Normalized Ratio | Partial thromboplastin time | Activated Partial Thromboplastin Time measurement
Item
6. pt/inr <1.5 x uln and ptt/ aptt <1.5 x uln
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C1531697 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
Histology Mixed | Small cell carcinoma of lung | Non-Small Cell Lung Carcinoma
Item
1. mixed small cell and nsclc histology
boolean
C0344441 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2])
C0007131 (UMLS CUI [3])
Central Nervous System Involvement Disease
Item
2. cns involvement of disease
boolean
C4050309 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Cancer treatment
Item
3. anti-tumor therapy within 21 days of study day 1
boolean
C0920425 (UMLS CUI [1])
Ibrutinib | Bruton tyrosine kinase inhibitors | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Other Coding | urelumab | Anti-CTLA-4 Monoclonal Antibody
Item
4. prior treatment with ibrutinib or other btk inhibitor and/or anti-pd1, anti-pd-l1, anti-pd-l2, anti-cd137 or ctla-4 antibody
boolean
C3501358 (UMLS CUI [1])
C0218158 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C1831875 (UMLS CUI [6])
C4289973 (UMLS CUI [7])
Organ Transplantation Allogeneic
Item
5. history of allogeneic organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
CYP3A Inhibitors
Item
6. treatment with a strong cytochrome p450 (cyp) 3a inhibitor
boolean
C3850056 (UMLS CUI [1])