ID

35851

Description

Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02228369

Link

https://clinicaltrials.gov/show/NCT02228369

Keywords

Versions (1)
  1. 3/27/19 3/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility EGFR Mutation Positive Advanced Non Small Cell Lung Cancer NCT02228369

English

Eligibility EGFR Mutation Positive Advanced Non Small Cell Lung Cancer NCT02228369

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. obtained written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female aged at least 18 years. aged at least 20 if japanese.
Description

Age | Japanese

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1556094
3. histologically or cytologically confirmed diagnosis of nsclc with single activating egfr mutations (l858r or exon19del).
Description

Non-Small Cell Lung Carcinoma | EGFR Exon 21 L858R Mutation | EGFR Exon 19 Deletion Mutation

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3274204
UMLS CUI [3]
C4289657
4. eastern cooperative oncology group performance status of 0 to1. for lm patients, 0 to 2 is acceptable.
Description

ECOG performance status | Metastatic Malignant Neoplasm to the Leptomeninges

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1704231
5. in part a, prior treatment with at least one line of a single agent egfr tki and at least 1 line of chemotherapy.
Description

Prior Therapy | Epidermal growth factor receptor inhibitor Course Quantity | Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
6. in part b-bm expansion, progressed intracranially following immediate prior treatment of an egfr tki but with stable extracranial disease. for part b-lm expansion, patients who received previous egfr tki treatment must have stable extracranial disease;egfr tki treatment naïve patients can also be enrolled into azd9291 cohorts, or azd3759 cohorts if efficacy signal seen in part a and agreed by safety review committee.
Description

Metastatic malignant neoplasm to brain Expansion | Disease Progression Intracranial | Prior Therapy | Epidermal growth factor receptor inhibitor | Stable Disease Extracranial | Metastatic Malignant Neoplasm to the Leptomeninges Expansion | Epidermal growth factor receptor inhibitor Absent | AZD9291 Cohort | AZD3759 Cohort

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1519678
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0524466
UMLS CUI [3]
C1514463
UMLS CUI [4]
C1443775
UMLS CUI [5,1]
C0677946
UMLS CUI [5,2]
C0580586
UMLS CUI [6,1]
C1704231
UMLS CUI [6,2]
C1519678
UMLS CUI [7,1]
C1443775
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C3896906
UMLS CUI [8,2]
C0599755
UMLS CUI [9,1]
C3896908
UMLS CUI [9,2]
C0599755
7. for patients with neither lm nor measurable bm: at least one measurable extracranial lesion. for patients with measurable bm but without lm: at least one measurable intracranial lesion
Description

Measurable lesion Extracranial Quantity | Measurable lesion Intracranial Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0580586
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0524466
UMLS CUI [2,3]
C1265611
8. for patients with lm: confirmed diagnosis of lm by positive csf cytology.
Description

Metastatic Malignant Neoplasm to the Leptomeninges | Cerebrospinal Fluid Cytology Positive

Data type

boolean

Alias
UMLS CUI [1]
C1704231
UMLS CUI [2,1]
C0007806
UMLS CUI [2,2]
C1305671
UMLS CUI [2,3]
C1514241
9. male patients should be willing to use barrier contraception, i.e., condoms, until 3 months after last study drug is taken.
Description

Gender Barrier Contraception | Condoms, Male

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C0009653
10. females should agree to use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
Description

Gender Contraceptive methods | Breast Feeding Absent | Childbearing Potential Pregnancy test negative | Female infertility

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4]
C0021361
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. for patients with lm and/or bm, cns complications that require urgent neurosurgical intervention
Description

Central nervous system complication | Requirement Neurosurgical Procedures Urgent

Data type

boolean

Alias
UMLS CUI [1]
C0161815
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0524850
UMLS CUI [2,3]
C0439609
2. for patient with lm, inability to undergo collection of csf
Description

Cerebrospinal fluid collection Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0394552
UMLS CUI [1,2]
C1299582
3. treatment with an egfr tki (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is the longer, of the first dose of study treatment.
Description

Epidermal growth factor receptor inhibitor | erlotinib | gefitinib

Data type

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C1135135
UMLS CUI [3]
C1122962
4. any cytotoxic chemotherapy,or other anticancer drugs for the treatment of advanced nsclc from a previous treatment regimen within 14 days of the first dose of study treatment
Description

Cytotoxic Chemotherapy | Antineoplastic Agents | Therapy Non-Small Cell Lung Carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0003392
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0007131
UMLS CUI [3,3]
C0205179
5. radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment with the exception of patients receiving radiation to more than 30% of the bone marrow which must be completed within 4 weeks of the first dose of study treatment.
Description

Therapeutic radiology procedure Radiation Field Wide | Radiation Field Limited Palliative Care | Exception Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0332464
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0030231
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0005953
UMLS CUI [3,4]
C0439165
6. patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of azd3759/azd9291) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome p450 3a4/5 and potential inhibitors of cytochrome p450 2c8 (for patients to be enrolled into azd9291 cohorts only).
Description

CYP3A4 Inhibitor | CYP3A4 Inducers | CYP3A5 Inhibitors | CYP3A5 Inducers | CYP2C8 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3850041
UMLS CUI [3]
C3850054
UMLS CUI [4]
C3850043
UMLS CUI [5]
C3850061
7. past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Description

Lung Diseases, Interstitial | Drug-induced interstitial lung disorder | Radiation Pneumonitis Requirement Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0348822
UMLS CUI [3,1]
C0206063
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0149783
8. known intracranial haemorrhage which is unrelated to tumour
Description

Intracranial Hemorrhage | Relationship Absent Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0027651
9. refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of azd3759/azd9291
Description

Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Lacking Able to swallow Investigational New Drugs | Bowel resection Excludes Absorption AZD3759 | Bowel resection Excludes Absorption AZD9291

Data type

boolean

Alias
UMLS CUI [1]
C3697880
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0741614
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C3896908
UMLS CUI [5,1]
C0741614
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C3896906
10. any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses
Description

Systemic disease Severe | Systemic disease Uncontrolled | Uncontrolled hypertension | Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1868885
UMLS CUI [4]
C1458140
11. inadequate bone marrow reserve or organ function
Description

Few mature neutrophils in the bone marrow | Organ function Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C0205412
12. clinically significant ecg abnormalities or any factors that increase the risk of corrected qt interval prolongation or risk of arrhythmic events
Description

Electrocardiogram abnormal | Factor At risk Prolonged QTc interval | Factor At risk Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1560305
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0003811
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Similar models

Eligibility EGFR Mutation Positive Advanced Non Small Cell Lung Cancer NCT02228369

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. obtained written informed consent
boolean
C0021430 (UMLS CUI [1])
Age | Japanese
Item
2. male or female aged at least 18 years. aged at least 20 if japanese.
boolean
C0001779 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma | EGFR Exon 21 L858R Mutation | EGFR Exon 19 Deletion Mutation
Item
3. histologically or cytologically confirmed diagnosis of nsclc with single activating egfr mutations (l858r or exon19del).
boolean
C0007131 (UMLS CUI [1])
C3274204 (UMLS CUI [2])
C4289657 (UMLS CUI [3])
ECOG performance status | Metastatic Malignant Neoplasm to the Leptomeninges
Item
4. eastern cooperative oncology group performance status of 0 to1. for lm patients, 0 to 2 is acceptable.
boolean
C1520224 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Prior Therapy | Epidermal growth factor receptor inhibitor Course Quantity | Chemotherapy Quantity
Item
5. in part a, prior treatment with at least one line of a single agent egfr tki and at least 1 line of chemotherapy.
boolean
C1514463 (UMLS CUI [1])
C1443775 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Expansion | Disease Progression Intracranial | Prior Therapy | Epidermal growth factor receptor inhibitor | Stable Disease Extracranial | Metastatic Malignant Neoplasm to the Leptomeninges Expansion | Epidermal growth factor receptor inhibitor Absent | AZD9291 Cohort | AZD3759 Cohort
Item
6. in part b-bm expansion, progressed intracranially following immediate prior treatment of an egfr tki but with stable extracranial disease. for part b-lm expansion, patients who received previous egfr tki treatment must have stable extracranial disease;egfr tki treatment naïve patients can also be enrolled into azd9291 cohorts, or azd3759 cohorts if efficacy signal seen in part a and agreed by safety review committee.
boolean
C0220650 (UMLS CUI [1,1])
C1519678 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0524466 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3])
C1443775 (UMLS CUI [4])
C0677946 (UMLS CUI [5,1])
C0580586 (UMLS CUI [5,2])
C1704231 (UMLS CUI [6,1])
C1519678 (UMLS CUI [6,2])
C1443775 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C3896906 (UMLS CUI [8,1])
C0599755 (UMLS CUI [8,2])
C3896908 (UMLS CUI [9,1])
C0599755 (UMLS CUI [9,2])
Measurable lesion Extracranial Quantity | Measurable lesion Intracranial Quantity
Item
7. for patients with neither lm nor measurable bm: at least one measurable extracranial lesion. for patients with measurable bm but without lm: at least one measurable intracranial lesion
boolean
C1513041 (UMLS CUI [1,1])
C0580586 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0524466 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Metastatic Malignant Neoplasm to the Leptomeninges | Cerebrospinal Fluid Cytology Positive
Item
8. for patients with lm: confirmed diagnosis of lm by positive csf cytology.
boolean
C1704231 (UMLS CUI [1])
C0007806 (UMLS CUI [2,1])
C1305671 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Gender Barrier Contraception | Condoms, Male
Item
9. male patients should be willing to use barrier contraception, i.e., condoms, until 3 months after last study drug is taken.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
Gender Contraceptive methods | Breast Feeding Absent | Childbearing Potential Pregnancy test negative | Female infertility
Item
10. females should agree to use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0021361 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Central nervous system complication | Requirement Neurosurgical Procedures Urgent
Item
1. for patients with lm and/or bm, cns complications that require urgent neurosurgical intervention
boolean
C0161815 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0524850 (UMLS CUI [2,2])
C0439609 (UMLS CUI [2,3])
Cerebrospinal fluid collection Unable
Item
2. for patient with lm, inability to undergo collection of csf
boolean
C0394552 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Epidermal growth factor receptor inhibitor | erlotinib | gefitinib
Item
3. treatment with an egfr tki (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is the longer, of the first dose of study treatment.
boolean
C1443775 (UMLS CUI [1])
C1135135 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
Cytotoxic Chemotherapy | Antineoplastic Agents | Therapy Non-Small Cell Lung Carcinoma Advanced
Item
4. any cytotoxic chemotherapy,or other anticancer drugs for the treatment of advanced nsclc from a previous treatment regimen within 14 days of the first dose of study treatment
boolean
C0677881 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
Therapeutic radiology procedure Radiation Field Wide | Radiation Field Limited Palliative Care | Exception Therapeutic radiology procedure Bone Marrow Percentage
Item
5. radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment with the exception of patients receiving radiation to more than 30% of the bone marrow which must be completed within 4 weeks of the first dose of study treatment.
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0332464 (UMLS CUI [1,3])
C1882536 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0030231 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0005953 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
CYP3A4 Inhibitor | CYP3A4 Inducers | CYP3A5 Inhibitors | CYP3A5 Inducers | CYP2C8 Inhibitors
Item
6. patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of azd3759/azd9291) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome p450 3a4/5 and potential inhibitors of cytochrome p450 2c8 (for patients to be enrolled into azd9291 cohorts only).
boolean
C3830624 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
C3850054 (UMLS CUI [3])
C3850043 (UMLS CUI [4])
C3850061 (UMLS CUI [5])
Lung Diseases, Interstitial | Drug-induced interstitial lung disorder | Radiation Pneumonitis Requirement Steroid therapy
Item
7. past medical history of interstitial lung disease, drug-induced interstitial lung disease, 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])
Intracranial Hemorrhage | Relationship Absent Neoplasm
Item
8. known intracranial haemorrhage which is unrelated to tumour
boolean
C0151699 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Lacking Able to swallow Investigational New Drugs | Bowel resection Excludes Absorption AZD3759 | Bowel resection Excludes Absorption AZD9291
Item
9. refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of azd3759/azd9291
boolean
C3697880 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0741614 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C3896908 (UMLS CUI [4,4])
C0741614 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C3896906 (UMLS CUI [5,4])
Systemic disease Severe | Systemic disease Uncontrolled | Uncontrolled hypertension | Bleeding tendency
Item
10. any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses
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])
Few mature neutrophils in the bone marrow | Organ function Inadequate
Item
11. inadequate bone marrow reserve or organ function
boolean
C2748959 (UMLS CUI [1])
C0678852 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Electrocardiogram abnormal | Factor At risk Prolonged QTc interval | Factor At risk Cardiac Arrhythmia
Item
12. clinically significant ecg abnormalities or any factors that increase the risk of corrected qt interval prolongation or risk of arrhythmic events
boolean
C0522055 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0003811 (UMLS CUI [3,3])
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