ID

38427

Beskrivning

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s); ODM derived from: https://clinicaltrials.gov/show/NCT01853826

Länk

https://clinicaltrials.gov/show/NCT01853826

Nyckelord

Versioner (1)
  1. 2019-10-17 2019-10-17 -
Rättsinnehavare

See clinicaltrials.gov

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17 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01853826

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT01853826

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with:
Beskrivning

Patients

Datatyp

boolean

Alias
UMLS CUI [1]
C0030705
locally advanced or metastatic non-small cell lung cancer (nsclc)
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
epidermal growth factor receptor (egfr) mutation-positive result per the institution's testing methodology.
Beskrivning

EGFR mutation Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1514241
adequate organ function, defined as all of the following:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
1. absolute neutrophil count (anc) > 1500/mm3. (anc >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
Beskrivning

Absolute neutrophil count | Cyclic neutropenia Benign

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0221023
UMLS CUI [2,2]
C0205183
2. platelet count >75,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
3. serum creatinine < 1.5 times of the upper limit of normal
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
4. total bilirubin < 1.5 times upper limit of (institutional) normal (patients with gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
Beskrivning

Serum total bilirubin measurement | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
5. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (uln) (if related to liver metastases < five times uln).
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
eastern cooperative oncology group (ecog) score between 0 - 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonisation (ich)- good clinical practice (gcp) guidelines and local law.
Beskrivning

Informed Consent | Informed Consent Legal Guardians

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who or with:
Beskrivning

Patients

Datatyp

boolean

Alias
UMLS CUI [1]
C0030705
prior treatment with an egfr tyrosine kinase inhibitor (tki)
Beskrivning

EGFR Tyrosine Kinase inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1443775
anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
Beskrivning

Cancer treatment | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analog Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002842
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023610
UMLS CUI [3,3]
C0243071
UMLS CUI [3,4]
C0600139
radiotherapy within 14 days prior to drug administration, except as follows:
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
Beskrivning

Exception Palliative course of radiotherapy Organ | Chest Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0475092
UMLS CUI [1,3]
C0178784
UMLS CUI [2,1]
C0817096
UMLS CUI [2,2]
C0332196
2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Beskrivning

Exception Palliative course of radiotherapy Neoplasm Metastasis Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0475092
UMLS CUI [1,3]
C0027627
UMLS CUI [1,4]
C0231220
previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
Beskrivning

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasms In complete remission | Exception Malignant Neoplasms Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C1880198
known pre-existing interstitial lung disease
Beskrivning

Interstitial Lung Disease Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of medication)
Beskrivning

Meningeal Carcinomatosis | Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0220650
UMLS CUI [3,3]
C0231221
UMLS CUI [3,4]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0677946
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01853826

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Patients
Item
patients with:
boolean
C0030705 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic
Item
locally advanced or metastatic non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
EGFR mutation Positive
Item
epidermal growth factor receptor (egfr) mutation-positive result per the institution's testing methodology.
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Organ function
Item
adequate organ function, defined as all of the following:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count | Cyclic neutropenia Benign
Item
1. absolute neutrophil count (anc) > 1500/mm3. (anc >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
boolean
C0948762 (UMLS CUI [1])
C0221023 (UMLS CUI [2,1])
C0205183 (UMLS CUI [2,2])
Platelet Count measurement
Item
2. platelet count >75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
3. serum creatinine < 1.5 times of the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Gilbert Disease
Item
4. total bilirubin < 1.5 times upper limit of (institutional) normal (patients with gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
5. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (uln) (if related to liver metastases < five times uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score between 0 - 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians
Item
written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonisation (ich)- good clinical practice (gcp) guidelines and local law.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patients
Item
patients who or with:
boolean
C0030705 (UMLS CUI [1])
EGFR Tyrosine Kinase inhibitor
Item
prior treatment with an egfr tyrosine kinase inhibitor (tki)
boolean
C1443775 (UMLS CUI [1])
Cancer treatment | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analog Prostate carcinoma
Item
anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0002842 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0023610 (UMLS CUI [3,2])
C0243071 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure
Item
radiotherapy within 14 days prior to drug administration, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative course of radiotherapy Organ | Chest Excluded
Item
1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
boolean
C1705847 (UMLS CUI [1,1])
C0475092 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Exception Palliative course of radiotherapy Neoplasm Metastasis Symptomatic
Item
2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
boolean
C1705847 (UMLS CUI [1,1])
C0475092 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasms In complete remission | Exception Malignant Neoplasms Cured
Item
previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
Interstitial Lung Disease Pre-existing
Item
known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Meningeal Carcinomatosis | Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease
Item
meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of medication)
boolean
C0220654 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1522326 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])
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