Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic
Item
1. 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 gene mutation Positive
Item
2. epidermal growth factor receptor (egfr) mutation-positive results per the institution's testing methodology
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Age
Item
3. male or female patients age >=18 years
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
4. adequate organ function, defined as all of the following:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) >1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count>75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
3. serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Serum total bilirubin measurement
Item
4. total bilirubin <1.5 times upper limit of (institutional) normal
boolean
C1278039 (UMLS CUI [1])
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 (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
5. eastern cooperative oncology group (ecog) score between 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Informed Consent Guardian
Item
6. written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonization (ich)- good clinical practice (gcp) guidelines and local law
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Toxicity Prior Therapy Related | Recovery CTCAE Grades | Exception Sensory neuropathy Stable CTCAE Grades | Exception Alopecia
Item
7. recovery from any previous therapy related toxicity to <=ctcae grade 1 at study entry (except for stable sensory neuropathy <=ctcae grade 2 and alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0151313 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1516728 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0002170 (UMLS CUI [4,2])
EGFR Tyrosine Kinase Inhibitor
Item
1. prior treatment with an egfr tyrosine kinase inhibitor (tki)
boolean
C1443775 (UMLS CUI [1])
Hormone Therapy | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analogue Prostate carcinoma
Item
2. hormonal 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
C0279025 (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
3. radiotherapy within 28 days prior to drug administration, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative Radiation Therapy 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])
C3898008 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Exception Palliative Care Dose Single | Exception Palliative Care Neoplasm Metastasis Symptomatic
Item
2. single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling
boolean
C1705847 (UMLS CUI [1,1])
C0030231 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0030231 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0231220 (UMLS CUI [2,4])
Major surgery | Patient scheduled for surgery
Item
4. major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
boolean
C0679637 (UMLS CUI [1])
C3242215 (UMLS CUI [2])
Hypersensitivity Afatinib | Hypersensitivity Afatinib Excipient
Item
5. known hypersensitivity to afatinib or any of its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2987648 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2987648 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction
Item
6. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association (nyha) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting trial treatment
boolean
C0243050 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
7. women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Childbearing Potential
Item
8. childbearing potential who:
boolean
C3831118 (UMLS CUI [1])
Breast Feeding
Item
1. are nursing or
boolean
C0006147 (UMLS CUI [1])
Pregnancy
Item
2. are pregnant or
boolean
C0032961 (UMLS CUI [1])
Contraceptive methods Absent | Pregnancy Tests Rejected
Item
3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032976 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
Condition compromises Protocol Compliance | Condition Interferes with Evaluation Investigational New Drug
Item
9. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Malignant Neoplasms Site Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Ductal carcinoma in situ | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured
Item
10. 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
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
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])
Illicit medication use Discontinue Unsuccessful
Item
11. requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
boolean
C0281875 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Interstitial Lung Disease Pre-existing
Item
12. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Gastrointestinal Diseases Poorly controlled Affecting Absorption Investigational New Drug | Crohn Disease | Ulcerative Colitis | Malabsorption | Diarrhea CTCAE Grades
Item
13. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. crohn¿s disease, ulcerative colitis, malabsorption, or ctc grade =2 diarrhea of any aetiology) based on investigator assessment
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,5])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C3714745 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Hepatitis B | Hepatitis B Surface Antigens Present | Hepatitis B virus DNA Present | Hepatitis C | Hepatitis C virus RNA Present | Human immunodeficiency virus carrier
Item
14. active hepatitis b infection (defined as presence of hepatitis b (hepb) sag and/or hepb dna), active hepatitis c (hep c) infection (defined as presence of hep c rna) and/or known human immunodeficiency virus (hiv) carrier
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0369332 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4])
C0369335 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C0421166 (UMLS CUI [6])
Meningeal Carcinomatosis
Item
15. meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease | Exception Adrenal Cortex Hormones Dose Stable
Item
16. 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 corticosteroid)
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0677946 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])