Non-small cell lung cancer metastatic | Non-small cell lung cancer recurrent Curative treatment failed
Item
1. patients must have histologically or cytologically confirmed stage iv non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
boolean
C0278987 (UMLS CUI [1])
C0278517 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
2. patients must have measurable disease by response evaluation criteria in solid tumors(recist) 1.1 criteria
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
EGFR gene mutation | Clinical Laboratory Improvement Act Test
Item
3. documented egfr mutation by clinical laboratory improvement amendments (clia)-certified test
boolean
C3266992 (UMLS CUI [1])
C2827061 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
Disease Progression | Therapeutic procedure | erlotinib | gefitinib | Afatinib | Epidermal growth factor receptor inhibitor
Item
4. documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other egfr-targeted tyrosine kinase inhibitor
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C1122962 (UMLS CUI [4])
C2987648 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
Body tissue Availability of | Biopsy | Operative Surgical Procedures
Item
5. there must be tissue available from a biopsy or surgical procedure performed after progression on an egfr targeted tyrosine kinase inhibitor. if tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy
boolean
C0040300 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Age
Item
6. age >/=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status </=2
boolean
C1520224 (UMLS CUI [1])
Able to swallow Pills
Item
8. ability to take pills by mouth
boolean
C2712086 (UMLS CUI [1,1])
C0994475 (UMLS CUI [1,2])
organ function | Bone Marrow physiological aspects | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Bilirubin, total measurement
Item
9. patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcl; absolute neutrophil count >/= 1,500/mcl; hemoglobin >/= 9 g/dl; total bilirubin </= 1.5 x institutional upper limit of normal (uln); ast(sgot)/alt(sgpt) </= 2.5 × uln or </= 5 x uln if metastases to the liver; creatinine clearance >/= 45 ml/min
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0019046 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
Metastatic malignant neoplasm to brain Asymptomatic | Anticonvulsants | Steroids | Prednisone | Therapeutic radiology procedure
Item
10. patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. maximum daily dose of steroids should be prednisone 20 mg or equivalent. radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0003286 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C0032952 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Ibrutinib | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy | Males Contraceptive methods
Item
11. the effects of ibrutinib on the developing human fetus are unknown. women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
boolean
C3501358 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
C0086582 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
Informed consent
Item
12. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Epidermal growth factor receptor inhibitor | Pharmaceutical Preparations Against Malignant Neoplasms
Item
1. patients who have received egfr tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
boolean
C1443775 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Prior Therapy Ibrutinib
Item
2. prior treatment with ibrutinib
boolean
C1514463 (UMLS CUI [1,1])
C3501358 (UMLS CUI [1,2])
Hypersensitivity Ibrutinib
Item
3. known hypersensitivity to ibrutinib
boolean
C0020517 (UMLS CUI [1,1])
C3501358 (UMLS CUI [1,2])
Cytochrome P-450 CYP3A Inducers Use Concurrent | Cytochrome P-450 CYP3A Inhibitors Use Concurrent
Item
4. concurrent use of agents that strongly inhibit or induce cyp3a unless use is approved by the medical monitor
boolean
C3850044 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C3850056 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0205420 (UMLS CUI [2,3])
Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | Social situation
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0748872 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
6. pregnant and nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Other | Malignant neoplasm of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Curative treatment
Item
7. patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0007114 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0007124 (UMLS CUI [4])
C1273390 (UMLS CUI [5])
Gastrointestinal Disease Limiting Intestinal Absorption Ibrutinib
Item
8. any gastrointestinal disorder expected to limit absorption of ibrutinib
boolean
C0017178 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021826 (UMLS CUI [1,3])
C3501358 (UMLS CUI [1,4])
Therapeutic procedure Warfarin | Treatment with Vitamin K antagonist
Item
9. treatment with warfarin or other vitamin k antagonist. patients with using warfarin who switch to another form of anticoagulation will be eligible
boolean
C0087111 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C1096489 (UMLS CUI [2])
Persistent atrial fibrillation Uncontrolled
Item
10. patients with persistent and uncontrolled atrial fibrillation.
boolean
C2585653 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])