Patients
Item
patients with:
boolean
C0030705 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic
Item
locally advanced or metastatic non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
EGFR mutation Positive
Item
epidermal growth factor receptor (egfr) mutation-positive result per the institution's testing methodology.
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Organ function
Item
adequate organ function, defined as all of the following:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count | Cyclic neutropenia Benign
Item
1. absolute neutrophil count (anc) > 1500/mm3. (anc >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
boolean
C0948762 (UMLS CUI [1])
C0221023 (UMLS CUI [2,1])
C0205183 (UMLS CUI [2,2])
Platelet Count measurement
Item
2. platelet count >75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
3. serum creatinine < 1.5 times of the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Gilbert Disease
Item
4. total bilirubin < 1.5 times upper limit of (institutional) normal (patients with gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
5. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (uln) (if related to liver metastases < five times uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score between 0 - 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians
Item
written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonisation (ich)- good clinical practice (gcp) guidelines and local law.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Patients
Item
patients who or with:
boolean
C0030705 (UMLS CUI [1])
EGFR Tyrosine Kinase inhibitor
Item
prior treatment with an egfr tyrosine kinase inhibitor (tki)
boolean
C1443775 (UMLS CUI [1])
Cancer treatment | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analog Prostate carcinoma
Item
anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0002842 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0023610 (UMLS CUI [3,2])
C0243071 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure
Item
radiotherapy within 14 days prior to drug administration, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative course of radiotherapy Organ | Chest Excluded
Item
1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
boolean
C1705847 (UMLS CUI [1,1])
C0475092 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Exception Palliative course of radiotherapy Neoplasm Metastasis Symptomatic
Item
2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
boolean
C1705847 (UMLS CUI [1,1])
C0475092 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasms In complete remission | Exception Malignant Neoplasms Cured
Item
previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
Interstitial Lung Disease Pre-existing
Item
known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Meningeal Carcinomatosis | Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease
Item
meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of medication)
boolean
C0220654 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1522326 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])