Age
Item
patients 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging | Prior Therapy Absent
Item
histologically or cytologically confirmed, stage iv non-squamous nsclc without any prior treatment
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Tumor tissue sample PD-L1 Positive
Item
tumor pd-l1 expression as determined by immunohistochemistry (ihc) assay of archival tumor tissue or tissue obtained at screening
boolean
C0475358 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as defined by response evaluation criteria in solid tumors (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])
CNS metastases CT | CNS metastases Untreated CT | CNS metastases MRI | CNS metastases Untreated MRI
Item
active or untreated central nervous system (cns) metastases as determined by computed tomorgaphy (ct) or magnetic resonance imaging (mri) evaluation
boolean
C0686377 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0686377 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0686377 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Cancer Other | Exception Low Risk Metastasis | Exception Low Risk Death | Exception Curative procedure
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
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0011065 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1276305 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease
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 allowed
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 [6,1])
C1882536 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
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 | Immune system Blockade Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody
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])
C2987634 (UMLS CUI [1,2])
C0020962 (UMLS CUI [2,1])
C0332206 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
Communicable Disease Severe
Item
severe infection within 4 weeks prior to randomization
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiovascular Disease
Item
significant history of cardiovascular disease
boolean
C0007222 (UMLS CUI [1])