ID

15710

Description

A Phase III Study of MPDL3280A (Anti-PD-L1) in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-paclitaxel Compared With Carboplatin + Nab-paclitaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower 131]; ODM derived from: https://clinicaltrials.gov/show/NCT02367794

Link

https://clinicaltrials.gov/show/NCT02367794

Keywords

Versions (1)
  1. 6/9/16 6/9/16 -
Uploaded on

June 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02367794

English

Eligibility Non-Small Cell Lung Cancer NCT02367794

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Description

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Therapy naive Lung squamous cell carcinoma stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0854994
previously obtained archival tumor tissue or tissue obtained from biopsy at screening
Description

Tumor tissue sample Biopsy

Data type

boolean

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

Measurable Disease

Data type

boolean

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

Hematologic function | organ function

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or untreated central nervous system (cns) metastasis
Description

CNS metastases untreated

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Autoimmune Diseases

Data type

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
Description

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

Data type

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)
Description

HIV Seropositivity

Data type

boolean

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

Hepatitis B | Hepatitis C

Data type

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
Description

CD137 agonists

Data type

boolean

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

Communicable Diseases Severe

Data type

boolean

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

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02367794

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years 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 Lung squamous cell carcinoma stage IV
Item
histologically or cytologically confirmed, treatment-naïve stage iv squamous nsclc
boolean
C0919936 (UMLS CUI [1,1])
C0854994 (UMLS CUI [1,2])
Tumor tissue sample Biopsy
Item
previously obtained archival tumor tissue or tissue obtained from 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) metastasis
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 pd-1, 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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