ID

44259

Description

A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01017874

Link

https://clinicaltrials.gov/show/NCT01017874

Keywords

Versions (2)
  1. 7/15/18 7/15/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT01017874

English

Eligibility Non Small Cell Lung Cancer NCT01017874

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of nsclc with locally advanced or metastatic disease that is of non-squamous histology.
Description

Non-Squamous Non-Small Cell Lung Carcinoma Advanced Locally | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C4288755
participants must be "light ex-smokers" or "never-smokers".
Description

Former light tobacco smoker | Never smoked tobacco

Data type

boolean

Alias
UMLS CUI [1]
C3494627
UMLS CUI [2]
C0425293
"light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
Description

Former light tobacco smoker | Stopped smoking ___ years ago | Smoking cigarettes: ____ pack-years

Data type

boolean

Alias
UMLS CUI [1]
C3494627
UMLS CUI [2]
C3693442
UMLS CUI [3]
C2230126
"never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
Description

Never smoked tobacco | Smoking Cigarette Number Lifetime

Data type

boolean

Alias
UMLS CUI [1]
C0425293
UMLS CUI [2,1]
C0037369
UMLS CUI [2,2]
C0677453
UMLS CUI [2,3]
C0237753
UMLS CUI [2,4]
C4071830
participants must be of east asian ethnicity.
Description

East Asian ethnicity

Data type

boolean

Alias
UMLS CUI [1]
C4540996
no prior systemic therapy for lung cancer.
Description

Systemic therapy Absent Malignant neoplasm of lung

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0242379
eastern cooperative oncology group (ecog) performance status of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Description

Body Fluid Space Third Clinical Significance | Physical Examination | Ascites | Pleural effusion | Drainage Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0005889
UMLS CUI [1,2]
C1883067
UMLS CUI [1,3]
C0205437
UMLS CUI [1,4]
C2826293
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0032227
UMLS CUI [5,1]
C0013103
UMLS CUI [5,2]
C1272705
any evidence of clinically active interstitial lung disease. asymptomatic participants with chronic, stable, radiographic changes are eligible.
Description

Lung Diseases, Interstitial | Participants Asymptomatic | Radiography Change Stable chronic

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2,1]
C0679646
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C0034571
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0205191
participants whose epidermal growth factor receptor (egfr) mutation status is known prior to study entry will be excluded. participants in which egfr mutation testing has not been performed, or whose egfr mutation status is unknown or inconclusive at study entry are eligible.
Description

EGFR gene mutation

Data type

boolean

Alias
UMLS CUI [1]
C3266992
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Similar models

Eligibility Non Small Cell Lung Cancer NCT01017874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Squamous Non-Small Cell Lung Carcinoma Advanced Locally | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Item
histological diagnosis of nsclc with locally advanced or metastatic disease that is of non-squamous histology.
boolean
C4324656 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C4288755 (UMLS CUI [2])
Former light tobacco smoker | Never smoked tobacco
Item
participants must be "light ex-smokers" or "never-smokers".
boolean
C3494627 (UMLS CUI [1])
C0425293 (UMLS CUI [2])
Former light tobacco smoker | Stopped smoking ___ years ago | Smoking cigarettes: ____ pack-years
Item
"light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
boolean
C3494627 (UMLS CUI [1])
C3693442 (UMLS CUI [2])
C2230126 (UMLS CUI [3])
Never smoked tobacco | Smoking Cigarette Number Lifetime
Item
"never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
boolean
C0425293 (UMLS CUI [1])
C0037369 (UMLS CUI [2,1])
C0677453 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C4071830 (UMLS CUI [2,4])
East Asian ethnicity
Item
participants must be of east asian ethnicity.
boolean
C4540996 (UMLS CUI [1])
Systemic therapy Absent Malignant neoplasm of lung
Item
no prior systemic therapy for lung cancer.
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242379 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Body Fluid Space Third Clinical Significance | Physical Examination | Ascites | Pleural effusion | Drainage Unsuccessful
Item
presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
boolean
C0005889 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
C0013103 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
Lung Diseases, Interstitial | Participants Asymptomatic | Radiography Change Stable chronic
Item
any evidence of clinically active interstitial lung disease. asymptomatic participants with chronic, stable, radiographic changes are eligible.
boolean
C0206062 (UMLS CUI [1])
C0679646 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0034571 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
EGFR gene mutation
Item
participants whose epidermal growth factor receptor (egfr) mutation status is known prior to study entry will be excluded. participants in which egfr mutation testing has not been performed, or whose egfr mutation status is unknown or inconclusive at study entry are eligible.
boolean
C3266992 (UMLS CUI [1])
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