ID

15709

Beschreibung

A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Nab-Paclitaxel in Patients With Non-Squamous Non-Small Cell Lung Cancer [IMpower 130]; ODM derived from: https://clinicaltrials.gov/show/NCT02367781

Link

https://clinicaltrials.gov/show/NCT02367781

Stichworte

Versionen (1)
  1. 09.06.16 09.06.16 -
Hochgeladen am

9. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02367781

Englisch

Eligibility Non-Small Cell Lung Cancer NCT02367781

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Therapy naive Nonsquamous nonsmall cell neoplasm of lung

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C2585890
measurable disease, as defined by recist v1.1
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
previously obtained archival tumor or tissue obtained from a biopsy at screening
Beschreibung

Tumor tissue sample Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
adequate hematologic and end organ function
Beschreibung

Hematologic function | organ function

Datentyp

boolean

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

Exclusion Criteria

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

CNS metastases untreated

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Autoimmune Diseases

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

HIV Seropositivity

Datentyp

boolean

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

Hepatitis B | Hepatitis C

Datentyp

boolean

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

Prior Therapy CD137 agonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0214721
UMLS CUI [1,3]
C0243192
severe infection within 4 weeks prior to randomization
Beschreibung

Communicable Diseases Severe

Datentyp

boolean

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

Cardiovascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
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Ähnliche Modelle

Eligibility Non-Small Cell Lung Cancer NCT02367781

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Therapy naive Nonsquamous nonsmall cell neoplasm of lung
Item
histologically or cytologically confirmed, treatment-naive stage iv non-squamous nsclc
boolean
C0919936 (UMLS CUI [1,1])
C2585890 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease, as defined by recist v1.1
boolean
C1513041 (UMLS CUI [1])
Tumor tissue sample Biopsy
Item
previously obtained archival tumor or tissue obtained from a biopsy at screening
boolean
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
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])
Prior Therapy CD137 agonists
Item
prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti-pd-1, and anti-pd-l1 therapeutic antibody
boolean
C1514463 (UMLS CUI [1,1])
C0214721 (UMLS CUI [1,2])
C0243192 (UMLS CUI [1,3])
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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