Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent
Item
1. histologically or cytologically confirmed diagnosis of nsclc that is stage iiib, iv, or recurrent.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
Systemic Chemotherapy Quantity Non-Small Cell Lung Carcinoma TNM clinical staging | Systemic Chemotherapy Quantity Non-small cell lung cancer recurrent | Neoadjuvant Therapy Absent | Adjuvant therapy Absent
Item
2. received only 1 prior systemic chemotherapy regimen for stage iiib, iv, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (note: exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C1883256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278517 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of ≥12 weeks.
boolean
C0023671 (UMLS CUI [1])
docetaxel
Item
1. received prior treatment with docetaxel.
boolean
C0246415 (UMLS CUI [1])
CNS metastases | Eligibility Treatment completed CNS metastases | Eligibility Clinical status Stable
Item
2. known active central nervous system (cns) metastases. subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
boolean
C0686377 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0449440 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Eligibility Absence CNS metastases | Eligibility Absence Neurologic Symptoms CNS metastases
Item
1. no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases.
boolean
C1548635 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0686377 (UMLS CUI [1,3])
C1548635 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0235031 (UMLS CUI [2,3])
C0686377 (UMLS CUI [2,4])
Adrenal Cortex Hormones Dose Stable | Adrenal Cortex Hormones Dose Decreasing | Anticonvulsants Absent
Item
2. subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442797 (UMLS CUI [2,3])
C0003286 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
3. peripheral neuropathy ≥ grade 3.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Noninvasive
Item
4. current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0282612 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1707251 (UMLS CUI [7,2])
C2986496 (UMLS CUI [7,3])
Comorbidity Uncontrolled | Kidney Diseases | Liver diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Heart Diseases | Nervous system disorder | Cerebral disorder | Mental disorders
Item
5. significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0018799 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0234387 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
Blood Component Transfusion Unwilling
Item
6. unwilling to be transfused with blood components.
boolean
C0085430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])