ID

38619

Description

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01897480

Link

https://clinicaltrials.gov/show/NCT01897480

Keywords

Versions (1)
  1. 10/28/19 10/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01897480

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT01897480

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of metastatic stage iv nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
have at least 1 measurable lesion whose presence is assessable using standard techniques by response evaluation criteria in solid tumors (recist version 1.1)
Description

Measurable lesion Quantity | Assessment Using Standard Technique

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C1442989
UMLS CUI [2,4]
C0449851
have molecular evidence of an epidermal growth factor receptor mutation (egfrmt) known to be associated with egfr tyrosine kinase inhibitor (tki) drug sensitivity (g719x, exon 19 deletion, l858r, l861q)
Description

EGFR gene mutation Associated with Hypersensitivity EGFR Tyrosine Kinase inhibitor | EGFR G719X | EGFR Exon 19 Deletion Mutation | EGFR L858R | EGFR L861Q

Data type

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C1443775
UMLS CUI [2]
C3830332
UMLS CUI [3]
C4289657
UMLS CUI [4]
C3274204
UMLS CUI [5]
C3274186
eastern cooperative oncology group (ecog) performance status of ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
haven't received any prior systemic chemotherapy for stage iv nsclc (unless received as neoadjuvant or adjuvant therapy for early-stage nsclc disease and completed therapy at least 6 months prior to enrollment)
Description

Systemic Chemotherapy Absent NSCLC TNM clinical staging | Exception Neoadjuvant Therapy Early stage NSCLC | Exception Adjuvant therapy Early stage NSCLC | Exception Treatment completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0007131
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C2363430
UMLS CUI [2,4]
C0007131
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0677850
UMLS CUI [3,3]
C2363430
UMLS CUI [3,4]
C0007131
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0580352
availability of adequate tumor material (block or slides)
Description

Availability of Tumor tissue sample | Block | Slide

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C1533157
UMLS CUI [3]
C1705201
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
have previously completed or withdrawn from this study or any other study investigating ly2875358
Description

Study Subject Participation Status | Scientific investigation LY2875358

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0683933
UMLS CUI [2,2]
C2987383
have a serious concomitant systemic disorder or significant cardiac disease
Description

Comorbidity Systemic Serious | Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0018799
have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
Description

Pneumonia, Interstitial | Interstitial lung fibrosis | Pleural effusion | Pericardial effusion | Ascites | Requirement Drainage Frequency

Data type

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C3887486
UMLS CUI [3]
C0032227
UMLS CUI [4]
C0031039
UMLS CUI [5]
C0003962
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0013103
UMLS CUI [6,3]
C0439603
have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
Description

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Recurrent disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0280100
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0277556
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
have major surgery less than 2 weeks prior to the initiation of study treatment therapy
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01897480

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed diagnosis of metastatic stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable lesion Quantity | Assessment Using Standard Technique
Item
have at least 1 measurable lesion whose presence is assessable using standard techniques by response evaluation criteria in solid tumors (recist version 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C1442989 (UMLS CUI [2,3])
C0449851 (UMLS CUI [2,4])
EGFR gene mutation Associated with Hypersensitivity EGFR Tyrosine Kinase inhibitor | EGFR G719X | EGFR Exon 19 Deletion Mutation | EGFR L858R | EGFR L861Q
Item
have molecular evidence of an epidermal growth factor receptor mutation (egfrmt) known to be associated with egfr tyrosine kinase inhibitor (tki) drug sensitivity (g719x, exon 19 deletion, l858r, l861q)
boolean
C3266992 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C1443775 (UMLS CUI [1,4])
C3830332 (UMLS CUI [2])
C4289657 (UMLS CUI [3])
C3274204 (UMLS CUI [4])
C3274186 (UMLS CUI [5])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Systemic Chemotherapy Absent NSCLC TNM clinical staging | Exception Neoadjuvant Therapy Early stage NSCLC | Exception Adjuvant therapy Early stage NSCLC | Exception Treatment completed
Item
haven't received any prior systemic chemotherapy for stage iv nsclc (unless received as neoadjuvant or adjuvant therapy for early-stage nsclc disease and completed therapy at least 6 months prior to enrollment)
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C2363430 (UMLS CUI [2,3])
C0007131 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C2363430 (UMLS CUI [3,3])
C0007131 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0580352 (UMLS CUI [4,2])
Availability of Tumor tissue sample | Block | Slide
Item
availability of adequate tumor material (block or slides)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1533157 (UMLS CUI [2])
C1705201 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Study Subject Participation Status | Scientific investigation LY2875358
Item
have previously completed or withdrawn from this study or any other study investigating ly2875358
boolean
C2348568 (UMLS CUI [1])
C0683933 (UMLS CUI [2,1])
C2987383 (UMLS CUI [2,2])
Comorbidity Systemic Serious | Heart Disease
Item
have a serious concomitant systemic disorder or significant cardiac disease
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2])
Pneumonia, Interstitial | Interstitial lung fibrosis | Pleural effusion | Pericardial effusion | Ascites | Requirement Drainage Frequency
Item
have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
boolean
C0206061 (UMLS CUI [1])
C3887486 (UMLS CUI [2])
C0032227 (UMLS CUI [3])
C0031039 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C1514873 (UMLS CUI [6,1])
C0013103 (UMLS CUI [6,2])
C0439603 (UMLS CUI [6,3])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Recurrent disease Free Duration
Item
have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0280100 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0277556 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Major surgery
Item
have major surgery less than 2 weeks prior to the initiation of study treatment therapy
boolean
C0679637 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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