ID

35153

Description

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older; ODM derived from: https://clinicaltrials.gov/show/NCT02514174

Link

https://clinicaltrials.gov/show/NCT02514174

Keywords

Versions (1)
  1. 2/20/19 2/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02514174

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02514174

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically or cytologically confirmed nsclc
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. stage iv cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. the staging is based on american joint commitee on cancer (ajcc) classification of malignant tumours (tnm) 7th edition (r12-4710)
Description

Malignant Neoplasm TNM clinical staging | Pleural effusion | Pericardial effusion | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0031039
UMLS CUI [4]
C0277556
3. evidence of common egfr mutation (del 19 and/or l858r)
Description

EGFR gene mutation | EGFR Exon 19 Deletion Mutation | EGFR L858R Mutation

Data type

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2]
C4289657
UMLS CUI [3]
C3274204
4. age = 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. eastern cooperative oncology group (ecog) performance status 0-1 (r01- 0787)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. no prior systemic therapy for metastatic or recurrent nsclc.
Description

Systemic therapy Absent Non-small cell lung cancer metastatic | Systemic therapy Absent Non-small cell lung cancer recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0278987
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0278517
further inclusion criteria apply.
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
Description

Study Subject Participation Status | Afatinib

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2987648
2. concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
Description

Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
3. radiotherapy within 4 weeks prior to start of study treatment, except as follows:
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
i.) palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Description

Exception Palliative Radiation Therapy Organ target(s) | Chest Excluded | Exception Palliative treatment Dose Single | Exception Palliative treatment Neoplasm Metastasis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C3898008
UMLS CUI [1,3]
C0807185
UMLS CUI [2,1]
C0817096
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030231
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205171
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0030231
UMLS CUI [4,3]
C0027627
UMLS CUI [4,4]
C0231220
4. major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
Description

Major surgery | Patient scheduled for surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3242215
5. systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
Description

Systemic Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
6. men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
Description

Male fertility Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1955321
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
further exclusion criteria apply.
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02514174

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. pathologically or cytologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Malignant Neoplasm TNM clinical staging | Pleural effusion | Pericardial effusion | Recurrent disease
Item
2. stage iv cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. the staging is based on american joint commitee on cancer (ajcc) classification of malignant tumours (tnm) 7th edition (r12-4710)
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
EGFR gene mutation | EGFR Exon 19 Deletion Mutation | EGFR L858R Mutation
Item
3. evidence of common egfr mutation (del 19 and/or l858r)
boolean
C3266992 (UMLS CUI [1])
C4289657 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
Age
Item
4. age = 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status 0-1 (r01- 0787)
boolean
C1520224 (UMLS CUI [1])
Systemic therapy Absent Non-small cell lung cancer metastatic | Systemic therapy Absent Non-small cell lung cancer recurrent
Item
6. no prior systemic therapy for metastatic or recurrent nsclc.
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278987 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278517 (UMLS CUI [2,3])
Inclusion criteria Additional
Item
further inclusion criteria apply.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Afatinib
Item
1. prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
boolean
C2348568 (UMLS CUI [1])
C2987648 (UMLS CUI [2])
Therapy, Investigational
Item
2. concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
boolean
C0949266 (UMLS CUI [1])
Therapeutic radiology procedure
Item
3. radiotherapy within 4 weeks prior to start of study treatment, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative Radiation Therapy Organ target(s) | Chest Excluded | Exception Palliative treatment Dose Single | Exception Palliative treatment Neoplasm Metastasis Symptomatic
Item
i.) palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
boolean
C1705847 (UMLS CUI [1,1])
C3898008 (UMLS CUI [1,2])
C0807185 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0030231 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0231220 (UMLS CUI [4,4])
Major surgery | Patient scheduled for surgery
Item
4. major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
boolean
C0679637 (UMLS CUI [1])
C3242215 (UMLS CUI [2])
Systemic Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs
Item
5. systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
boolean
C1883256 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Male fertility Contraceptive methods Unwilling
Item
6. men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
boolean
C1955321 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Exclusion Criteria Additional
Item
further exclusion criteria apply.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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