ID

36586

Description

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT02094261

Link

https://clinicaltrials.gov/show/NCT02094261

Keywords

Versions (1)
  1. 5/23/19 5/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT02094261

English

Eligibility Non Small Cell Lung Cancer NCT02094261

1 forms  
Criteria
Description

Criteria

aged at least 18 years. japan patients aged at least 20 years.
Description

Age | Japanese

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1556094
locally advanced/metastatic nsclc not amenable to curative surgery or radiotherapy
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Disease Inappropriate Curative Surgery | Disease Inappropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1522449
radiological documentation of disease progression:
Description

Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
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.
Description

First line treatment EGFR Tyrosine Kinase Inhibitor | Prior Therapy EGFR Tyrosine Kinase Inhibitor | Chemotherapy Platinum-Based Double | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1443775
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1443775
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C0205173
UMLS CUI [4]
C0242656
disease progression following 1st line egfr tki treatment or following prior egfr tki and platinum-containing doublet chemotherapy.
Description

Disease Progression | Status post First line treatment EGFR Tyrosine Kinase Inhibitor | Status post EGFR Tyrosine Kinase Inhibitor | Status post Chemotherapy Platinum-Based Double

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C1443775
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1443775
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C1514162
UMLS CUI [4,4]
C0205173
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3273083
UMLS CUI [2]
C3830332
UMLS CUI [3]
C3889117
UMLS CUI [4]
C3274204
UMLS CUI [5]
C3274186
UMLS CUI [6,1]
C3274192
UMLS CUI [6,2]
C0026882
UMLS CUI [6,3]
C1514241
UMLS CUI [6,4]
C0677862
UMLS CUI [7]
C0087111
UMLS CUI [8]
C0242656
world health organisation (who) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Description

WHO performance status scale | Deterioration Absent | Life Expectancy Minimum

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2,1]
C1279889
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0023671
UMLS CUI [3,2]
C1524031
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0552406
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0552406
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C0024204
UMLS CUI [6,2]
C0522488
UMLS CUI [6,3]
C0040405
UMLS CUI [7,1]
C0024204
UMLS CUI [7,2]
C0522488
UMLS CUI [7,3]
C0024485
females of child-bearing potential using contraception; negative pregnancy test.
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
exclusion:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0003392
UMLS CUI [5]
C3896906
UMLS CUI [6,1]
C1443775
UMLS CUI [6,2]
C0079411
UMLS CUI [6,3]
C0205437
UMLS CUI [7]
C0679637
UMLS CUI [8,1]
C1522449
UMLS CUI [8,2]
C0005953
UMLS CUI [8,3]
C0439165
UMLS CUI [9,1]
C1522449
UMLS CUI [9,2]
C1882536
UMLS CUI [9,3]
C0332464
UMLS CUI [10,1]
C3850061
UMLS CUI [10,2]
C0442821
UMLS CUI [11,1]
C3850053
UMLS CUI [11,2]
C0442821
UMLS CUI [12,1]
C3850041
UMLS CUI [12,2]
C0442821
unresolved toxicities from prior therapy.
Description

Toxicity Due to Prior Therapy | Resolution Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
unstable spinal cord compression/brain metastases.
Description

Compression of spinal cord Unstable | Metastatic malignant neoplasm to brain Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0037926
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0443343
severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
Description

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

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
UMLS CUI [5]
C0009450
refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection.
Description

Intractable nausea and vomiting | Gastrointestinal Diseases chronic | Bowel resection

Data type

boolean

Alias
UMLS CUI [1]
C3697880
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0741614
cardiac disease.
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
past history of ild, drug-induced ild, 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
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
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Similar models

Eligibility Non Small Cell Lung Cancer NCT02094261

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
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