Non-Small Cell Lung Carcinoma TNM clinical staging
Item
1. pathologically or cytologically confirmed diagnosis of stage iiib or stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Conventional Treatment Quantity failed | Therapeutic procedure Effective Lacking
Item
2. patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
boolean
C2945704 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1280519 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Malignant Neoplasms
Item
3. patients whose tumors:
boolean
C0006826 (UMLS CUI [1])
EGFR gene mutation Positive
Item
are egfr mutation-positive or
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
EGFR gene mutation Negative | EGFR gene mutation Unknown | Disease Progression | erlotinib | Tarceva | gefitinib | Iressa | Disease Response | Stable Disease
Item
are egfr mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (tarceva®) or gefitinib (iressa®)
boolean
C3266992 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3266992 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C1135135 (UMLS CUI [4])
C1135136 (UMLS CUI [5])
C1122962 (UMLS CUI [6])
C0919281 (UMLS CUI [7])
C1704632 (UMLS CUI [8])
C0677946 (UMLS CUI [9])
Age
Item
4. patients aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least three (3) months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog, r01-0787) performance score 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
7. written informed consent that is consistent with ich-gcp guidelines
boolean
C0021430 (UMLS CUI [1])
Major surgery | Chemotherapy | Therapeutic radiology procedure
Item
1. prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
boolean
C0679637 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
mTOR Inhibitor
Item
2. prior treatment with an mtor inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
boolean
C2746052 (UMLS CUI [1])
erlotinib | Tarceva | gefitinib | Iressa | Sirolimus
Item
3. use of erlotinib (tarceva®) or gefitinib (iressa®) within 14 days of run-in treatment with sirolimus
boolean
C1135135 (UMLS CUI [1])
C1135136 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
C0919281 (UMLS CUI [4])
C0072980 (UMLS CUI [5])
CNS metastases Stable | CNS metastases Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Steroids
Item
4. active cns metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
boolean
C0686377 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003286 (UMLS CUI [3,3])
C0686377 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0038317 (UMLS CUI [4,3])
Fasting cholesterol level Alteration Severe | Triglycerides measurement Alteration Severe | Enrollment allowed Post Initiation Hypolipidemic Agents
Item
5. severe alteration in serum fasting cholesterol (equal or more than 350 mg/dl) or triglycerides (equal or more than 400 mg/dl). patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
boolean
C1282513 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0202236 (UMLS CUI [2,1])
C1515926 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C1516879 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1704686 (UMLS CUI [3,4])
C0086440 (UMLS CUI [3,5])
Illicit drug use
Item
6. requirement for treatment with any of the prohibited concomitant medications:
boolean
C0281875 (UMLS CUI [1])
CYP3A4 Inhibitors
Item
concomitant cyp3a4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
boolean
C3850053 (UMLS CUI [1])
CYP3A4 Inducers
Item
concomitant cyp3a4 inducers within the past 14 days before start of therapy or concomitantly with this study.
boolean
C3850041 (UMLS CUI [1])
Medical contraindication Sirolimus
Item
7. any contraindications for therapy with sirolimus.
boolean
C1301624 (UMLS CUI [1,1])
C0072980 (UMLS CUI [1,2])
Hypersensitivity BIBW 2992 | Hypersensitivity Sirolimus | Hypersensitivity Rapamycin Analogue | Hypersensitivity everolimus | Hypersensitivity temsirolimus | Hypersensitivity deforolimus | Hypersensitivity Investigational New Drugs Excipient
Item
8. known hypersensitivity to bibw 2992, sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
boolean
C0020517 (UMLS CUI [1,1])
C4083270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0243071 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1707080 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C2713007 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
Investigational New Drugs
Item
9. use of any investigational drug within 4 weeks before start of therapy.
boolean
C0013230 (UMLS CUI [1])