Age | Japanese
Item
aged at least 18 years. japan patients aged at least 20 years.
boolean
C0001779 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Inappropriate Curative Surgery | Disease Inappropriate Therapeutic radiology procedure
Item
locally advanced/metastatic nsclc not amenable to curative surgery or radiotherapy
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Disease Progression
Item
radiological documentation of disease progression:
boolean
C0242656 (UMLS CUI [1])
First line treatment EGFR Tyrosine Kinase Inhibitor | Prior Therapy EGFR Tyrosine Kinase Inhibitor | Chemotherapy Platinum-Based Double | Disease Progression
Item
following 1st line egfr tki treatment but who have not received further treatment or following prior therapy with an egfr tki and a platinum-based doublet chemotherapy. patients who received prior egfr tki and platinum-based doublet chemotherapy may have also received additional lines of treatment. all patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
boolean
C1708063 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1443775 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
Disease Progression | Status post First line treatment EGFR Tyrosine Kinase Inhibitor | Status post EGFR Tyrosine Kinase Inhibitor | Status post Chemotherapy Platinum-Based Double
Item
disease progression following 1st line egfr tki treatment or following prior egfr tki and platinum-containing doublet chemotherapy.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1443775 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1443775 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C1514162 (UMLS CUI [4,3])
C0205173 (UMLS CUI [4,4])
Neoplasm EGFR-TKI Sensitizing Mutation | EGFR G719X | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | EGFR T790M Mutation Positive Biopsy sample | Therapeutic procedure | Disease Progression
Item
confirmation that the tumour harbours an egfr mutation known to be associated with egfr tki sensitivity (including g719x, exon 19 deletion, l858r, l861q). patients must have central confirmation of tumour t790m mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
boolean
C0027651 (UMLS CUI [1,1])
C3273083 (UMLS CUI [1,2])
C3830332 (UMLS CUI [2])
C3889117 (UMLS CUI [3])
C3274204 (UMLS CUI [4])
C3274186 (UMLS CUI [5])
C3274192 (UMLS CUI [6,1])
C0026882 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
C0677862 (UMLS CUI [6,4])
C0087111 (UMLS CUI [7])
C0242656 (UMLS CUI [8])
WHO performance status scale | Deterioration Absent | Life Expectancy Minimum
Item
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
boolean
C1298650 (UMLS CUI [1])
C1279889 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3,1])
C1524031 (UMLS CUI [3,2])
Measurable lesion Quantity | Prior radiation therapy Absent | Biopsy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Lymph nodes Short axis CT | Lymph nodes Short axis MRI
Item
at least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerised tomography (ct) or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C0552406 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C0552406 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C0024204 (UMLS CUI [6,1])
C0522488 (UMLS CUI [6,2])
C0040405 (UMLS CUI [6,3])
C0024204 (UMLS CUI [7,1])
C0522488 (UMLS CUI [7,2])
C0024485 (UMLS CUI [7,3])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
females of child-bearing potential using contraception; negative pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
EGFR Tyrosine Kinase Inhibitor | Cytotoxic Chemotherapy | Investigational New Drugs | Antineoplastic Agents | AZD9291 | EGFR Tyrosine Kinase Inhibitor Generation Third | Major surgery | Therapeutic radiology procedure Bone Marrow Percentage | Therapeutic radiology procedure Radiation Field Wide | CYP2C8 Inhibitors Strong | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
treatment with an egfr-tki within 8 days of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with azd9291 (or 3rd generation tkis); major surgery within 4 weeks; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks; current treatment with potent inhibitors of cyp2c8 and potent inhibitors/inducers of cyp3a4.
boolean
C1443775 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C3896906 (UMLS CUI [5])
C1443775 (UMLS CUI [6,1])
C0079411 (UMLS CUI [6,2])
C0205437 (UMLS CUI [6,3])
C0679637 (UMLS CUI [7])
C1522449 (UMLS CUI [8,1])
C0005953 (UMLS CUI [8,2])
C0439165 (UMLS CUI [8,3])
C1522449 (UMLS CUI [9,1])
C1882536 (UMLS CUI [9,2])
C0332464 (UMLS CUI [9,3])
C3850061 (UMLS CUI [10,1])
C0442821 (UMLS CUI [10,2])
C3850053 (UMLS CUI [11,1])
C0442821 (UMLS CUI [11,2])
C3850041 (UMLS CUI [12,1])
C0442821 (UMLS CUI [12,2])
Toxicity Due to Prior Therapy | Resolution Lacking
Item
unresolved toxicities from prior therapy.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain Unstable
Item
unstable spinal cord compression/brain metastases.
boolean
C0037926 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Systemic disease Severe | Systemic disease Uncontrolled | Uncontrolled hypertension | Bleeding tendency | Communicable Diseases
Item
severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C1458140 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Bowel resection
Item
refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection.
boolean
C3697880 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0741614 (UMLS CUI [3])
Heart Disease
Item
cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Lung Diseases, Interstitial | Drug-induced interstitial lung disorder | Radiation Pneumonitis Requirement Steroid therapy
Item
past history of ild, drug-induced ild, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
boolean
C0206062 (UMLS CUI [1])
C0348822 (UMLS CUI [2])
C0206063 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0149783 (UMLS CUI [3,3])
Few mature neutrophils in the bone marrow | Organ function Inadequate
Item
inadequate bone marrow reserve or organ function.
boolean
C2748959 (UMLS CUI [1])
C0678852 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])