Criteria Fulfill
Item
patients must meet the following criteria for study entry:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Availability of Tumor tissue sample
Item
availability of a tumor specimen
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Recurrent disease | Progressive Disease | Chemotherapy Quantity Disease TNM clinical staging
Item
recurrent or progressive disease following at least one chemo containing regimen for stage iiib/iv disease
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
Measurable Disease
Item
measurable disease in accordance with response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
Measurable lesion Quantity FDG-PET Pretreatment | Target Lesion CT
Item
at least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron emission tomography (fdg-pet) scan that is also a target lesion on computed tomography (ct) according to recist
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
C3539075 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Prior Therapy Quantity TNM clinical staging
Item
more than two prior treatments for stage iiib/iv
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exposure to EGFR inhibitor | Toxicity EGFR Related | Toxicity Resulting in Dose Modification
Item
more than 30 days of exposure to an investigational or marketed agent that can act by egfr inhibition, or a known epidermal growth factor receptor (egfr)-related toxicity resulting in dose modifications
boolean
C0332157 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C1707811 (UMLS CUI [3,3])
Chemotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs
Item
chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
CNS metastases untreated | CNS metastases Progressive | CNS metastases Requirement Control Symptomatic | CNS metastases Requirement Anticonvulsants | CNS metastases Requirement Adrenal Cortex Hormones
Item
untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (cns) metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
C0231220 (UMLS CUI [3,4])
C0686377 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003286 (UMLS CUI [4,3])
C0686377 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0001617 (UMLS CUI [5,3])
Systemic disease Serious
Item
history of serious systemic disease within the past 6 months prior to randomization
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Major surgery | Traumatic injury
Item
major surgical procedure or significant traumatic injury within 28 days prior to randomization
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
Anticipation Patient need for Major surgery
Item
anticipation of need for a major surgical procedure during the course of the study
boolean
C0679106 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0679637 (UMLS CUI [1,3])
Palliative course of radiotherapy Local | Adverse effect of radiation therapy Persistent | Absence Resolution CTCAE grades
Item
local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to grade ii or less prior to randomization
boolean
C0475092 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0392615 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Hypercalcemia Symptomatic | Requirement Diphosphonates
Item
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])