ID

15711

Beskrivning

A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer [IMpower 150]; ODM derived from: https://clinicaltrials.gov/show/NCT02366143

Länk

https://clinicaltrials.gov/show/NCT02366143

Nyckelord

  1. 2016-06-09 2016-06-09 -
Uppladdad den

9 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02366143

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02366143

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed, treatment-naïve stage iv non-squamous nsclc
Beskrivning

Therapy naive Nonsquamous nonsmall cell neoplasm of lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C2585890
previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
Beskrivning

Tumor tissue sample Biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
measurable disease as defined by recist v1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate hematologic and end organ function
Beskrivning

Hematologic function | organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or untreated central nervous system (cns) metastases
Beskrivning

CNS metastases untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Beskrivning

Malignant Neoplasms | Non-Small Cell Lung Carcinoma | At risk Neoplasm Metastasis | At risk Cessation of life

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0011065
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of autoimmune disease
Beskrivning

Autoimmune Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Beskrivning

Idiopathic Pulmonary Fibrosis | Organized pneumonia | Drug-induced pneumonitis | Pneumonitis idiopathic | Pneumonitis Chest CT | Radiation Pneumonitis | Radiation Field | Fibrosis

Datatyp

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2]
C0264383
UMLS CUI [3]
C1960026
UMLS CUI [4,1]
C3714636
UMLS CUI [4,2]
C0332240
UMLS CUI [5,1]
C3714636
UMLS CUI [5,2]
C0202823
UMLS CUI [6]
C0206063
UMLS CUI [7]
C1882536
UMLS CUI [8]
C0016059
positive test for human immunodeficiency virus (hiv)
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
active hepatitis b or hepatitis c
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti pd1, and anti-pd-l1 therapeutic antibody
Beskrivning

CD137 agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0214721
UMLS CUI [1,2]
C0243192
severe infection within 4 weeks prior to randomization
Beskrivning

Communicable Diseases Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
significant history of cardiovascular disease
Beskrivning

Cardiovascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222

Similar models

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02366143

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Therapy naive Nonsquamous nonsmall cell neoplasm of lung
Item
histologically or cytologically confirmed, treatment-naïve stage iv non-squamous nsclc
boolean
C0919936 (UMLS CUI [1,1])
C2585890 (UMLS CUI [1,2])
Tumor tissue sample Biopsy
Item
previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease as defined by recist v1.1
boolean
C1513041 (UMLS CUI [1])
Hematologic function | organ function
Item
adequate hematologic and end organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
CNS metastases untreated
Item
active or untreated central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Malignant Neoplasms | Non-Small Cell Lung Carcinoma | At risk Neoplasm Metastasis | At risk Cessation of life
Item
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
boolean
C0006826 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1444641 (UMLS CUI [4,1])
C0011065 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Diseases
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Organized pneumonia | Drug-induced pneumonitis | Pneumonitis idiopathic | Pneumonitis Chest CT | Radiation Pneumonitis | Radiation Field | Fibrosis
Item
history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
boolean
C1800706 (UMLS CUI [1])
C0264383 (UMLS CUI [2])
C1960026 (UMLS CUI [3])
C3714636 (UMLS CUI [4,1])
C0332240 (UMLS CUI [4,2])
C3714636 (UMLS CUI [5,1])
C0202823 (UMLS CUI [5,2])
C0206063 (UMLS CUI [6])
C1882536 (UMLS CUI [7])
C0016059 (UMLS CUI [8])
HIV Seropositivity
Item
positive test for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
CD137 agonists
Item
prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti pd1, and anti-pd-l1 therapeutic antibody
boolean
C0214721 (UMLS CUI [1,1])
C0243192 (UMLS CUI [1,2])
Communicable Diseases Severe
Item
severe infection within 4 weeks prior to randomization
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiovascular Diseases
Item
significant history of cardiovascular disease
boolean
C0007222 (UMLS CUI [1])

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