Non-small cell lung cancer recurrent TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | NSCLC recurrent Advanced Locally Inoperable | NSCLC metastatic Advanced Locally Inoperable
Item
histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage iiib or stage iv) nsclc.
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0205187 (UMLS CUI [3,4])
C0278987 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C0205187 (UMLS CUI [4,4])
Chemotherapy naive
Item
chemo-naïve patients.
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Patients Medically unfit Chemotherapy
Item
patients who are in the investigator's opinion not medically suitable for chemotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease according to the recist criteria.
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 - 3.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Able to swallow Oral medication
Item
patients must be able to take oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Normal serum calcium level
Item
serum calcium within normal ranges
boolean
C0580486 (UMLS CUI [1])
Operative Surgical Procedures | Therapeutic radiology procedure
Item
≥ 4 weeks since prior surgery or radiation therapy
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
for all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written (signed) informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Cancer treatment Systemic
Item
prior systemic antitumor therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Systemic disease Unstable | Medical contraindication Investigational New Drugs | High risk of Complications of treatment | Communicable Disease | Angina, Unstable | Myocardial Infarction | Inflammatory Bowel Diseases | Liver diseases | Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver | Kidney Diseases | Kidney Failure | Serum creatinine raised
Item
any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (uln) or ast and/or alt ≥ 2 x uln (or ≥ 5 x uln if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x uln.
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0679861 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0859062 (UMLS CUI [9])
C0151904 (UMLS CUI [10])
C0151905 (UMLS CUI [11])
C0439849 (UMLS CUI [12,1])
C0494165 (UMLS CUI [12,2])
C0022658 (UMLS CUI [13])
C0035078 (UMLS CUI [14])
C0700225 (UMLS CUI [15])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Breast Feeding | Pregnancy
Item
nursing mothers or pregnant woman.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Hypersensitivity Tarceva | Hypersensitivity Pharmaceutical Formulation Tarceva Similar
Item
hypersensitivity to tarceva or co-formulants.
boolean
C0020517 (UMLS CUI [1,1])
C1135136 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705957 (UMLS CUI [2,2])
C1135136 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent
Item
patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Patient's condition unstable | Steroid therapy Resistant
Item
patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0438114 (UMLS CUI [3])
C0149783 (UMLS CUI [4,1])
C0332325 (UMLS CUI [4,2])