Part Roman letter
Item
part a only:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Advanced Malignant Solid Neoplasm metastatic | Advanced Malignant Solid Neoplasm unresectable | Standard Curative treatment Unavailable | Standard Palliative Care Unavailable | Standard Curative treatment ineffective | Standard Palliative Care ineffective | Standard therapy Refused
Item
1. patients with histologically confirmed advanced solid tumours that are metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. patients who refuse standard therapy are also eligible.
boolean
C4329281 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C4329281 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1442989 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
C1442989 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0686905 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C3242229 (UMLS CUI [5,3])
C1442989 (UMLS CUI [6,1])
C0030231 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C2936643 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Part Roman letter
Item
part b only:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
2. pathologically confirmed diagnosis of stage iv (m1a or b) non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
EGFR T790M Mutation
Item
3. documented epidermal growth factor receptor (egfr) t790m mutation
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
Disease Progression | Tyrosine kinase inhibitor Reversible
Item
4. progression of disease on a reversible tyrosine kinase inhibitor within 30 days of starting study drug
boolean
C0242656 (UMLS CUI [1])
C1268567 (UMLS CUI [2,1])
C0205343 (UMLS CUI [2,2])
Part Roman letter
Item
parts a and b:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Evaluable Disease
Item
5. evaluable disease by response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1516986 (UMLS CUI [1])
Age
Item
6. age >/= to 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
8. adequate organ function
boolean
C0678852 (UMLS CUI [1])
Toxicity Prior Therapy Related | Patient recovered
Item
9. recovered from any previous therapy-related toxicity to </= to grade 1 at study entry (except for stable sensory neuropathy </= grade 2 and alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Informed Consent
Item
10. written informed consent
boolean
C0021430 (UMLS CUI [1])
Able to swallow Oral medication
Item
11. ability to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Part Roman letter
Item
parts a and b:
boolean
C0449719 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Chemotherapy | Biological treatment | Investigational New Drugs | Exception Erlotinib | Exception Gefitinib
Item
1. chemotherapy, biological therapy, or investigational agents (except erlotinib or gefitinib) within 4 weeks prior to the start of study treatment
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1135135 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1122962 (UMLS CUI [5,2])
Hormone Therapy | Antiandrogen therapy allowed Prostate carcinoma | Gonadorelin Analogue allowed Prostate carcinoma
Item
2. hormonal treatment within 2 weeks prior to the start of study treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer is permitted)
boolean
C0279025 (UMLS CUI [1])
C0279492 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C0023610 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure | Exception Palliative Radiation Therapy Symptom control
Item
3. radiotherapy within two weeks prior to the start of study treatment (except palliative radiotherapy given for symptom control)
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3898008 (UMLS CUI [2,2])
C1274136 (UMLS CUI [2,3])
Gefitinib Recent | Erlotinib Recent | Adverse event Gefitinib Related | Adverse event Erlotinib Related | Patient recovered CTCAE Grades
Item
4. less than 3 days from prior treatment with gefitinib or erlotinib. patients with adverse events related to gefitinib or erlotinib must recover to grade 1 or less to be eligible.
boolean
C1122962 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C1122962 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C1135135 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Major surgery | Major surgery Scheduled
Item
5. major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hypersensitivity Afatinib | Hypersensitivity Investigational New Drug Excipient
Item
6. known hypersensitivity to afatinib or the excipients of any of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C2987648 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (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
7. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting study 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 Sexual Abstinence Unwilling | Females & males of reproductive potential Contraceptive methods Unwilling
Item
8. women of childbearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
boolean
C4034483 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling
Item
9. female patients of childbearing potential who are nursing; are pregnant; are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study; and do not agree to submit to pregnancy testing required by this protocol
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Medical History compromises Protocol Compliance | Condition compromises Protocol Compliance | Medical History Interferes with Evaluation | Condition Interferes with Evaluation
Item
10. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
boolean
C0262926 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0220825 (UMLS CUI [4,3])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured
Item
11. 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])
llicit medication use Required | Illicit medication use Discontinue Unsuccessful
Item
12. required treatment with any of the prohibited medications listed in this protocol that cannot be stopped for the duration of trial participation
boolean
C0281875 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0281875 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Interstitial Lung Disease Pre-existing
Item
13. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Gastrointestinal Diseases Poorly controlled | Involvement with Absorption Investigational New Drugs | Crohn Disease | Ulcerative Colitis | Chronic diarrhea | Malabsorption
Item
14. any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (for example, crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) in the opinion of the investigator
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0010346 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0401151 (UMLS CUI [5])
C3714745 (UMLS CUI [6])
Hepatitis B | Hepatitis B DNA detectable | Hepatitis C | Hepatitis C RNA Present | Human immunodeficiency virus carrier
Item
15. active hepatitis b infection (defined as the presence of hepatitis b dna), active hepatitis c infection (defined as the presence of hepatitis c rna) and/or known human immunodeficiency virus carrier
boolean
C0019163 (UMLS CUI [1])
C1096264 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0855840 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
C0421166 (UMLS CUI [5])
Study Subject Participation Status | Blinded Clinical Study Afatinib
Item
16. prior participation in a blinded afatinib clinical study, unless permission to unblind was granted in consultation with the clinical monitor of the blinded study
boolean
C2348568 (UMLS CUI [1])
C2347038 (UMLS CUI [2,1])
C2987648 (UMLS CUI [2,2])
Meningeal Carcinomatosis
Item
17. meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Adrenal Cortex Hormones Discontinued | Exception Adrenal Cortex Hormones Dose Stable
Item
18. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued use of corticosteroids or have been on stable doses of corticosteroids for at least 4 weeks before starting study treatment. any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment
boolean
C0220650 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0038541 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0001617 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
QTc Interval Screening procedure
Item
19. qtc interval > 0.47 seconds as measured during screening procedures
boolean
C0860814 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])