Measurable Disease
Item
measureable disease according to the recist 1.1
boolean
C1513041 (UMLS CUI [1])
Prior radiation therapy Acceptable | Prior radiation therapy Absent Measurable lesion
Item
previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present
boolean
C0279134 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
Non-Squamous Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-squamous non-small cell lung cancer
boolean
C4324656 (UMLS CUI [1])
Disease TNM clinical staging Ineligibility Curative treatment | Disease TNM clinical staging
Item
stage iiib ineligible for curative therapy or stage iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C1273390 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Dysfunction Due to Malignant Neoplasms
Item
1. serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤ 3 x upper limit of normal (uln), or ast and alt ≤ 5 x uln if liver function abnormalities are due to underlying malignancy.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0086565 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
Serum total bilirubin measurement
Item
2. total serum bilirubin ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Absolute neutrophil count
Item
3. absolute neutrophil count (anc) ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelets ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement
Item
5. creatinine clearance > 45 ml/min
boolean
C0373595 (UMLS CUI [1])
Able Discontinue NSAIDs | Able Discontinue ASA | Renal function Reduced
Item
able to discontinue nsaids and asa if reduced renal function
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0004057 (UMLS CUI [2,3])
C0232804 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
Patients Fertile Contraceptive methods
Item
all fertile patients should use safe contraception
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Systemic therapy Non-Small Cell Lung Carcinoma Advanced | EGFR-TKI | Exception Prior Chemotherapy | Exception Adjuvant Chemotherapy Post Surgery | Exception Adjuvant Chemotherapy Cancer Other
Item
prior systemic therapy for advanced non-small-cell lung cancer (including egfr-tki). previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if
boolean
C1515119 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1443775 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1514457 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0085533 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0543467 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0085533 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
ID.16
Item
≥ 3 months since the last course was administered.
boolean
EGFR Activating Mutation | ALK Translocation
Item
activating egfr-mutation or alk-translocation detected
boolean
C2984891 (UMLS CUI [1])
C4329227 (UMLS CUI [2])
Comorbidity Serious Systemic | Communicable Disease | Cardiovascular Disease Unstable | Comorbidity compromises Completion of clinical trial | Comorbidity Interferes with Evaluation
Item
serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
Medical condition Preventing Information | Social situation Preventing Information | Mental condition Preventing Information | Medical condition Preventing Follow-up | Social situation Preventing Follow-up | Mental condition Preventing Follow-up
Item
conditions - medical, social, psychological - which could prevent adequate information and follow-up
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533716 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C1533716 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma
Item
clinically active cancer other than nsclc
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Vinorelbine | Medical contraindication Vinorelbine | Carboplatin allergy | Medical contraindication Carboplatin | Hypersensitivity Pemetrexed | Medical contraindication Pemetrexed | Vitamin B12 preparation allergy | Medical contraindication Vitamin B 12 | Hypersensitivity Folate | Medical contraindication Folate
Item
known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, b12, folate)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0078257 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0078257 (UMLS CUI [4,2])
C0570701 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0079083 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0210657 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0210657 (UMLS CUI [8,2])
C0571836 (UMLS CUI [9])
C1301624 (UMLS CUI [10,1])
C0042845 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0178638 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C0178638 (UMLS CUI [12,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])