ID

37245

Descripción

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026); ODM derived from: https://clinicaltrials.gov/show/NCT02041533

Link

https://clinicaltrials.gov/show/NCT02041533

Palabras clave

Versiones (1)
  1. 11/7/19 11/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Stage IV or Recurrent Non-Small Cell Lung Cancer NCT02041533

Inglés

Eligibility Stage IV or Recurrent Non-Small Cell Lung Cancer NCT02041533

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status (ps) ≤ 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed stage iv, or recurrent nsclc with no prior systemic anticancer therapy
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent | Cancer treatment Systemic Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278517
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0332197
measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors version (recist) 1.1 criteria
Descripción

Measurable Disease CT | Measurable Disease MRI

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
pd-l1+ on immunohistochemistry testing performed by central lab
Descripción

PD-L1 Positive Immunohistochemistry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4284303
UMLS CUI [1,2]
C0021044
men and women, ages ≥ 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known epidermal growth factor receptor (egfr) mutations which are sensitive to available targeted inhibitor therapy
Descripción

EGFR gene mutation | Sensitive Inhibitor Targeted Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2,1]
C0332324
UMLS CUI [2,2]
C1999216
UMLS CUI [2,3]
C2985566
known anaplastic lymphoma kinase (alk) translocations
Descripción

ALK Gene Translocation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4329227
untreated central nervous system (cns) metastases
Descripción

CNS metastases Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
previous malignancies
Descripción

Malignant Neoplasms Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
active, known or suspected autoimmune disease
Descripción

Autoimmune Disease | Autoimmune Disease Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0750491
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Similar models

Eligibility Stage IV or Recurrent Non-Small Cell Lung Cancer NCT02041533

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) ≤ 1
boolean
C1520224 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent | Cancer treatment Systemic Absent
Item
histologically confirmed stage iv, or recurrent nsclc with no prior systemic anticancer therapy
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Measurable Disease CT | Measurable Disease MRI
Item
measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors version (recist) 1.1 criteria
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
PD-L1 Positive Immunohistochemistry
Item
pd-l1+ on immunohistochemistry testing performed by central lab
boolean
C4284303 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Age
Item
men and women, ages ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
EGFR gene mutation | Sensitive Inhibitor Targeted Therapy
Item
known epidermal growth factor receptor (egfr) mutations which are sensitive to available targeted inhibitor therapy
boolean
C3266992 (UMLS CUI [1])
C0332324 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C2985566 (UMLS CUI [2,3])
ALK Gene Translocation
Item
known anaplastic lymphoma kinase (alk) translocations
boolean
C4329227 (UMLS CUI [1])
CNS metastases Untreated
Item
untreated central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Malignant Neoplasms Previous
Item
previous malignancies
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Autoimmune Disease | Autoimmune Disease Suspected
Item
active, known or suspected autoimmune disease
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Volver a la parte superior de la página 

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