Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed stage iiib or iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Cancer treatment Systemic Quantity failed | Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic
Item
failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic nsclc
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0278987 (UMLS CUI [3])
Target Lesion Quantity Without Irradiation | Target Lesion Measurable Quantity
Item
at least one target lesion that is unirradiated and measurable by recist
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
ECOG performance status
Item
ecog 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
able to understand and sign an informed consent
boolean
C0021430 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Exception Irradiation of whole brain | Exception Stereotactic Radiosurgery | Exception Patient's condition stable | Exception Patient Asymptomatic | Exception Steroids Discontinued
Item
presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2064932 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3846112 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1282982 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0231221 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0038317 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
Gastrointestinal Disease | Other medical condition | Lacking Able to swallow Oral medication
Item
any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
boolean
C0017178 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Prostate carcinoma | Exception Curative treatment Superficial carcinoma of urinary bladder | Exception Curative treatment Solid Neoplasm | Exception Disease Free of
Item
history of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0600139 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C1336527 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0280100 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
Myocardial Ischemia Uncontrolled | Symptomatic congestive heart failure Uncontrolled
Item
uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
boolean
C0151744 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Communicable Disease Serious
Item
serious active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
psychiatric illness/ social situations that would limit study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Chronic disease Serious Uncontrolled | Condition Affecting Protocol Compliance
Item
other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Therapeutic radiology procedure Site Any | Therapeutic radiology procedure Recent | Prior radiation therapy Target Lesion Site
Item
concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
boolean
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C2986546 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
HIV Seropositivity | Antiretroviral therapy
Item
known hiv positive or on active anti-retroviral therapy
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C positive
Item
known hepatitis b surface antigen positive or hepatitis c positive
boolean
C0149709 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Investigational New Drugs
Item
receipt of any investigational medication within 4 weeks prior to randomization
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling
Item
pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0240802 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Gender Sexually active | Contraceptive methods Unwilling
Item
sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Legal capacity Lacking | Legal capacity Limited | Exception Authorization Legal Guardians
Item
legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0680281 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])