nsclc, tumor stage
Item
histologically or cytological proven nsclc, stage lll b (with pleural effusion) or stage lv.
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
nsclc, locally advanced, not suitable for surgery and radiotherapy is not indicated
Item
tumor is locally advanced and not suitable for surgery and radiotherapy is not indicated.
boolean
C0007131 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0920424 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
prior chemotherapy, prior immunotherapy
Item
neither cytostatic nor immunological pre-treatment
boolean
C1514457 (UMLS CUI [1])
C1514461 (UMLS CUI [2])
age
Item
age >70 years
boolean
C0001779 (UMLS CUI [1])
measurable lesion, not previously irradiated
Item
at least one measurable lesion (recist criteria) that was not previously irradiated
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
ecog
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 month
boolean
C0023671 (UMLS CUI [1])
anc, platelets
Item
adequate bone marrow function: anc > 1.5 x 109/l, platelets > 100 x 109/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
bilirubin, got, gpt
Item
adequate liver function: total bilirubin < 1.5 x uln, got/gpt< 3 x uln (existent liver metastases < 5 x uln)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
creatinine clearance
Item
adequate renal function:creatinine clearance > 45 ml/min (calculated according to cockroft-gault)
boolean
C0373595 (UMLS CUI [1])
gender, fertility, contraceptive methods
Item
fertile men must agree to use an effective method of birth control while participating in this study
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
cns metastasis, uncontrolled
Item
uncontrolled metastasis in the cns
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
infection, uncontrolled
Item
acute, heavy uncontrolled infection
boolean
C0275518 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
severe comorbidity
Item
any other serious concomitant disease or medical condition, which could interfere with participating in this study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
hypersensitivity erlotinib
Item
severe hypersensitivity to erlotinib or any other component
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
hypersensitivity carboplatin and/or other platinum compounds
Item
hypersensitivity to carboplatin and/or other platinum compounds
boolean
C0020517 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3536919 (UMLS CUI [2,2])
hypersensitivity to vinorelbin or other vinca-alkaloids
Item
hypersensitivity to vinorelbin or other vinca-alkaloids
boolean
C0020517 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042672 (UMLS CUI [2,2])
history of malignancy, with exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma
Item
patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.
boolean
C2735088 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C3281209 (UMLS CUI [3])
C0600139 (UMLS CUI [4,1])
C0277565 (UMLS CUI [4,2])
study subject participation status
Item
participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration
boolean
C2348568 (UMLS CUI [1])
compliance behaviour
Item
psychological, familial, social or geographical situations limiting the compliance with the study requirements
boolean
C1321605 (UMLS CUI [1])