Non-Small Cell Lung Carcinoma
Item
1. pathologically or cytologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Malignant Neoplasm TNM clinical staging | Pleural effusion | Pericardial effusion | Recurrent disease
Item
2. stage iv cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. the staging is based on american joint commitee on cancer (ajcc) classification of malignant tumours (tnm) 7th edition (r12-4710)
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
EGFR gene mutation | EGFR Exon 19 Deletion Mutation | EGFR L858R Mutation
Item
3. evidence of common egfr mutation (del 19 and/or l858r)
boolean
C3266992 (UMLS CUI [1])
C4289657 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
Age
Item
4. age = 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status 0-1 (r01- 0787)
boolean
C1520224 (UMLS CUI [1])
Systemic therapy Absent Non-small cell lung cancer metastatic | Systemic therapy Absent Non-small cell lung cancer recurrent
Item
6. no prior systemic therapy for metastatic or recurrent nsclc.
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278987 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278517 (UMLS CUI [2,3])
Inclusion criteria Additional
Item
further inclusion criteria apply.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Study Subject Participation Status | Afatinib
Item
1. prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
boolean
C2348568 (UMLS CUI [1])
C2987648 (UMLS CUI [2])
Therapy, Investigational
Item
2. concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
boolean
C0949266 (UMLS CUI [1])
Therapeutic radiology procedure
Item
3. radiotherapy within 4 weeks prior to start of study treatment, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative Radiation Therapy Organ target(s) | Chest Excluded | Exception Palliative treatment Dose Single | Exception Palliative treatment Neoplasm Metastasis Symptomatic
Item
i.) palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
boolean
C1705847 (UMLS CUI [1,1])
C3898008 (UMLS CUI [1,2])
C0807185 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0030231 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0231220 (UMLS CUI [4,4])
Major surgery | Patient scheduled for surgery
Item
4. 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])
C3242215 (UMLS CUI [2])
Systemic Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs
Item
5. systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
boolean
C1883256 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Male fertility Contraceptive methods Unwilling
Item
6. men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
boolean
C1955321 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Exclusion Criteria Additional
Item
further exclusion criteria apply.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])