ID

22193

Beschreibung

A Study of Pertuzumab in Combination With Erlotinib (Tarceva) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02507375

Link

https://clinicaltrials.gov/show/NCT02507375

Stichworte

Versionen (1)
  1. 22.05.17 22.05.17 -
Hochgeladen am

22. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients greater than or equal to 18 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histological confirmation of non-small cell lung cancer (nsclc)
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
locally advanced or metastatic disease
Beschreibung

Disease Advanced Local | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0027627
failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
Beschreibung

Disease Advanced Local | Neoplasm Metastasis | Chemotherapy Regimen Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
life expectancy of more than or equal to 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
baseline lvef of greater than or equal to 50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
a negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0600109
availability of histological ffpe tumor tissue
Beschreibung

Tumor Formalin-fixed paraffin-embedded tissue Availability of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
prior treatment with any agent which targets growth factors or their receptors
Beschreibung

Pharmaceutical Preparations Targeted Therapy Growth Factor | Pharmaceutical Preparations Targeted Therapy Growth Factor Receptors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0018284
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2985566
UMLS CUI [2,3]
C0206454
patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
Beschreibung

Chemotherapy Effects Reversible | Therapeutic radiology procedure Effects Reversible | Recovery Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0205343
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0205343
UMLS CUI [3,1]
C0237820
UMLS CUI [3,2]
C0332197
history of clinically significant cardiovascular disease
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
history or evidence of central nervous system metastases
Beschreibung

CNS metastases | CNS metastases Evidence of

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332120
treatment with any investigational drug within 28 days of the start of the study (day-8)
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
Beschreibung

Doxorubicin Cumulative Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
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Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients greater than or equal to 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma
Item
histological confirmation of non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Disease Advanced Local | Neoplasm Metastasis
Item
locally advanced or metastatic disease
boolean
C0012634 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2])
Disease Advanced Local | Neoplasm Metastasis | Chemotherapy Regimen Quantity failed
Item
failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
boolean
C0012634 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Life Expectancy
Item
life expectancy of more than or equal to 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
baseline lvef of greater than or equal to 50%
boolean
C0428772 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Willing
Item
a negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Tumor Formalin-fixed paraffin-embedded tissue Availability of
Item
availability of histological ffpe tumor tissue
boolean
C0027651 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Pharmaceutical Preparations Targeted Therapy Growth Factor | Pharmaceutical Preparations Targeted Therapy Growth Factor Receptors
Item
prior treatment with any agent which targets growth factors or their receptors
boolean
C0013227 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0206454 (UMLS CUI [2,3])
Chemotherapy Effects Reversible | Therapeutic radiology procedure Effects Reversible | Recovery Absent
Item
patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
C0237820 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiovascular Disease
Item
history of clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
CNS metastases | CNS metastases Evidence of
Item
history or evidence of central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Investigational New Drugs
Item
treatment with any investigational drug within 28 days of the start of the study (day-8)
boolean
C0013230 (UMLS CUI [1])
Doxorubicin Cumulative Dose
Item
prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
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