ID

35153

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02514174

Nyckelord

Versioner (1)
  1. 2019-02-20 2019-02-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 februari 2019

DOI

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Licens

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

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT02514174

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

boolean

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

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Inclusion criteria Additional

Datatyp

boolean

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

Exclusion Criteria

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

Study Subject Participation Status | Afatinib

Datatyp

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
Beskrivning

Therapy, Investigational

Datatyp

boolean

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

Therapeutic radiology procedure

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Major surgery | Patient scheduled for surgery

Datatyp

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).
Beskrivning

Systemic Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs

Datatyp

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.
Beskrivning

Male fertility Contraceptive methods Unwilling

Datatyp

boolean

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

Exclusion Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
Tillbaka till toppen

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02514174

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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