ID

14000

Beschrijving

Crizotinib Plus Pembrolizumab In Alk-positive Advanced Non Small Cell Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02511184

Link

https://clinicaltrials.gov/show/NCT02511184

Trefwoorden

  1. 21-03-16 21-03-16 -
Geüploaded op

21 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility ALK-positive Advanced NSCLC NCT02511184

Eligibility ALK-positive Advanced NSCLC NCT02511184

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous nsclc that is not suitable for local curative treatment.
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
alk-positive nsclc as determined by a test that is approved or validated for use as a companion diagnostic test.
Beschrijving

Alk-positive nsclc

Datatype

boolean

Alias
UMLS CUI [1,1]
C3888914
UMLS CUI [1,2]
C0007131
no prior systemic therapy for metastatic disease.
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
adjuvant chemotherapy more than 12 months prior to study enrollment.
Beschrijving

Adjuvant chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0085533
Measurable disease as per recist 1.1
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
Ecog ps 0 or 1.
Beschrijving

ECOG

Datatype

text

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to alk receptor tyrosine kinase inhibitor, anti-pd1, anti-pdl1 or any drug targeting t-cell checkpoint pathways.
Beschrijving

ALK receptor tyrosine kinase assay

Datatype

boolean

Alias
UMLS CUI [1]
C3203742
Known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
Beschrijving

Immunologic Deficiency Syndromes

Datatype

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C4039704
Active autoimmune disease that has required systemic treatment in the past 3 months.
Beschrijving

Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
history of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.
Beschrijving

Lung Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0206062

Similar models

Eligibility ALK-positive Advanced NSCLC NCT02511184

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous nsclc that is not suitable for local curative treatment.
boolean
C0007131 (UMLS CUI [1])
Alk-positive nsclc
Item
alk-positive nsclc as determined by a test that is approved or validated for use as a companion diagnostic test.
boolean
C3888914 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
no prior systemic therapy for metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Adjuvant chemotherapy
Item
adjuvant chemotherapy more than 12 months prior to study enrollment.
boolean
C0085533 (UMLS CUI [1])
Measurable Disease
Item
Measurable disease as per recist 1.1
boolean
C1513041 (UMLS CUI [1])
ECOG
Item
Ecog ps 0 or 1.
text
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ALK receptor tyrosine kinase assay
Item
prior exposure to alk receptor tyrosine kinase inhibitor, anti-pd1, anti-pdl1 or any drug targeting t-cell checkpoint pathways.
boolean
C3203742 (UMLS CUI [1])
Immunologic Deficiency Syndromes
Item
Known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
boolean
C0021051 (UMLS CUI [1])
C4039704 (UMLS CUI [2])
Autoimmune Diseases
Item
Active autoimmune disease that has required systemic treatment in the past 3 months.
boolean
C0004364 (UMLS CUI [1])
Lung Diseases
Item
history of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.
boolean
C0206062 (UMLS CUI [1])

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