ID

37245

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02041533

Nyckelord

  1. 2019-07-11 2019-07-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juli 2019

DOI

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Licens

Creative Commons BY 4.0

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

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

Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

ECOG performance status

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Measurable Disease CT | Measurable Disease MRI

Datatyp

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
Beskrivning

PD-L1 Positive Immunohistochemistry

Datatyp

boolean

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

EGFR gene mutation | Sensitive Inhibitor Targeted Therapy

Datatyp

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
Beskrivning

ALK Gene Translocation

Datatyp

boolean

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

CNS metastases Untreated

Datatyp

boolean

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

Malignant Neoplasms Previous

Datatyp

boolean

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

Autoimmune Disease | Autoimmune Disease Suspected

Datatyp

boolean

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

Similar models

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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

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