ID

38582

Description

A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants; ODM derived from: https://clinicaltrials.gov/show/NCT01900652

Lien

https://clinicaltrials.gov/show/NCT01900652

Mots-clés

Versions (1)
  1. 24.10.19 24.10.19 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

24. Oktober 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01900652

Anglais

Eligibility Carcinoma, Non-Small-Cell Lung NCT01900652

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of metastatic stage iv nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
at least 1 measurable extra-central nervous system (cns) lesion
Description

Measurable lesion Quantity | Exception Central nervous system lesion

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0742468
documented radiographic progression while on continuous treatment with erlotinib monotherapy
Description

Disease Progression Radiography | erlotinib

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0034571
UMLS CUI [2]
C1135135
objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (egfrmt) status, at least 12 weeks stable disease
Description

Benefit Clinical Due to Erlotinib | Partial response | In complete remission | Stable Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0814225
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1135135
UMLS CUI [2]
C1521726
UMLS CUI [3]
C0677874
UMLS CUI [4]
C0677946
determined to be met diagnostic positive (+)
Description

MET Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C1417123
UMLS CUI [1,2]
C1514241
availability of a tumor sample post-erlotinib progression
Description

Availability of Tumor tissue sample | Disease Progression | Status post Erlotinib

Type de données

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1135135
eastern cooperative oncology group (ecog) performance status ≤2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
have adequate organ function
Description

Organ function

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
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

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
have previously been treated with ly2875358 or any other met-targeting experimental therapeutic
Description

LY2875358 | Targeted Therapy MET

Type de données

boolean

Alias
UMLS CUI [1]
C2987383
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1417123
have a serious concomitant systemic disorder or significant cardiac disease
Description

Comorbidity Systemic Serious | Heart Disease

Type de données

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

Type de données

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

Type de données

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 initiation of study treatment therapy
Description

Major surgery

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have symptomatic cns metastasis
Description

CNS metastases Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01900652

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
diagnosis of metastatic stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable lesion Quantity | Exception Central nervous system lesion
Item
at least 1 measurable extra-central nervous system (cns) lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0742468 (UMLS CUI [2,2])
Disease Progression Radiography | erlotinib
Item
documented radiographic progression while on continuous treatment with erlotinib monotherapy
boolean
C0242656 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2])
Benefit Clinical Due to Erlotinib | Partial response | In complete remission | Stable Disease
Item
objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (egfrmt) status, at least 12 weeks stable disease
boolean
C0814225 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,4])
C1521726 (UMLS CUI [2])
C0677874 (UMLS CUI [3])
C0677946 (UMLS CUI [4])
MET Positive
Item
determined to be met diagnostic positive (+)
boolean
C1417123 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Availability of Tumor tissue sample | Disease Progression | Status post Erlotinib
Item
availability of a tumor sample post-erlotinib progression
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1135135 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
have adequate organ function
boolean
C0678852 (UMLS CUI [1])
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])
LY2875358 | Targeted Therapy MET
Item
have previously been treated with ly2875358 or any other met-targeting experimental therapeutic
boolean
C2987383 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C1417123 (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 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])
CNS metastases Symptomatic
Item
have symptomatic cns metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
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