ID

36650

Beschrijving

A Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least Two Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02409368

Link

https://clinicaltrials.gov/show/NCT02409368

Trefwoorden

Versies (2)
  1. 28-05-19 28-05-19 -
  2. 28-05-19 28-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02409368

Engels

Eligibility Non-Small Cell Lung Cancer NCT02409368

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
easter cooperative oncology group (ecog) status: performance status (ps) 0-1 & ps 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
subjects with histologically or cytologically-documented sqnsclc
Beschrijving

Squamous non-small cell lung cancer

Datatype

boolean

Alias
UMLS CUI [1]
C4509816
subjects must have experienced disease progression or recurrence during or after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
Beschrijving

Disease Progression | Recurrence | Status post Chemotherapy Platinum-Based Double | Status post Systemic therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0034897
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1514162
UMLS CUI [3,4]
C0205173
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1515119
UMLS CUI [4,3]
C1265611
subjects must have evaluable disease by ct or mri per response evaluation criteria in solid tumors (recist 1.1) criteria
Beschrijving

Evaluable Disease CT | Evaluable Disease MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516986
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0024485
subjects with treated or asymptomatic cns metastases
Beschrijving

CNS metastases Treated | CNS metastases Asymptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231221
prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
Beschrijving

Palliative course of radiotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0205197
males and females, ages 18 or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with untreated, symptomatic cns metastases
Beschrijving

CNS metastases Untreated | CNS metastases Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
subjects with carcinomatous meningitis
Beschrijving

Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1]
C0220654
subjects with active, known or suspected autoimmune disease
Beschrijving

Autoimmune Disease | Autoimmune Disease Suspected

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0750491
subjects who received prior therapy with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized bms clinical trial for nivolumab or ipilimumab
Beschrijving

Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Monoclonal Antibodies | Targeted Therapy T cell costimulation | Study Subject Participation Status | nivolumab

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C4289970
UMLS CUI [3]
C4289971
UMLS CUI [4,1]
C1705357
UMLS CUI [4,2]
C0003250
UMLS CUI [5,1]
C0214721
UMLS CUI [5,2]
C0003250
UMLS CUI [6]
C4289973
UMLS CUI [7]
C1367202
UMLS CUI [8]
C0003250
UMLS CUI [9,1]
C2985566
UMLS CUI [9,2]
C1622572
UMLS CUI [10]
C2348568
UMLS CUI [11]
C3657270
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02409368

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
easter cooperative oncology group (ecog) status: performance status (ps) 0-1 & ps 2
boolean
C1520224 (UMLS CUI [1])
Squamous non-small cell lung cancer
Item
subjects with histologically or cytologically-documented sqnsclc
boolean
C4509816 (UMLS CUI [1])
Disease Progression | Recurrence | Status post Chemotherapy Platinum-Based Double | Status post Systemic therapy Quantity
Item
subjects must have experienced disease progression or recurrence during or after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
boolean
C0242656 (UMLS CUI [1])
C0034897 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1514162 (UMLS CUI [3,3])
C0205173 (UMLS CUI [3,4])
C0231290 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Evaluable Disease CT | Evaluable Disease MRI
Item
subjects must have evaluable disease by ct or mri per response evaluation criteria in solid tumors (recist 1.1) criteria
boolean
C1516986 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
CNS metastases Treated | CNS metastases Asymptomatic
Item
subjects with treated or asymptomatic cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
Palliative course of radiotherapy Completed
Item
prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
boolean
C0475092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Age
Item
males and females, ages 18 or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases Untreated | CNS metastases Symptomatic
Item
subjects with untreated, symptomatic cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Meningeal Carcinomatosis
Item
subjects with carcinomatous meningitis
boolean
C0220654 (UMLS CUI [1])
Autoimmune Disease | Autoimmune Disease Suspected
Item
subjects with active, known or suspected autoimmune disease
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Monoclonal Antibodies | Targeted Therapy T cell costimulation | Study Subject Participation Status | nivolumab
Item
subjects who received prior therapy with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized bms clinical trial for nivolumab or ipilimumab
boolean
C1514463 (UMLS CUI [1])
C4289970 (UMLS CUI [2])
C4289971 (UMLS CUI [3])
C1705357 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C0214721 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C4289973 (UMLS CUI [6])
C1367202 (UMLS CUI [7])
C0003250 (UMLS CUI [8])
C2985566 (UMLS CUI [9,1])
C1622572 (UMLS CUI [9,2])
C2348568 (UMLS CUI [10])
C3657270 (UMLS CUI [11])
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