Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent
Item
locally advanced or metastatic (stage iiib, stage iv, or recurrent) non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3])
Tumor Formalin-fixed paraffin-embedded tissue specimen
Item
representative formalin-fixed paraffin-embedded (ffpe) tumor specimens
boolean
C0027651 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
Tumor status PD-L1 Positive Immunohistochemistry | PD-L1 Expression Immune Cell Tumor infiltration
Item
pd-l1-positive tumor status as determined by an ihc assay based on pd-l1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
boolean
C0475752 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C4284303 (UMLS CUI [2,1])
C4330475 (UMLS CUI [2,2])
C4060690 (UMLS CUI [2,3])
Measurable Disease
Item
measurable disease, as defined by recist v1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Cancer treatment | Chemotherapy | Hormone Therapy
Item
any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Tyrosine kinase inhibitor Treating Non-Small Cell Lung Carcinoma
Item
hormone-replacement therapy or oral contraceptives tkis approved for treatment of nslc discontinued > 7 days prior to cycle 1, day 1
boolean
C1705847 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0009905 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1268567 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0007131 (UMLS CUI [3,4])
CNS disorder | Metastatic malignant neoplasm to brain Treated
Item
central nervous system (cns) disease, including treated brain metastases.
boolean
C0007682 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma | Exception Low Risk Neoplasm Metastasis | Exception Low Risk Death | Exception Curative treatment Malignant Neoplasms
Item
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0011065 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Pneumonia | Drug-induced pneumonitis | Organized pneumonia | Pneumonitis CT scan | Radiation Pneumonitis Radiation Field allowed
Item
history of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening ct scan. history of radiation pneumonitis in the radiation field (fibrosis) id permitted.
boolean
C1800706 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
C1960026 (UMLS CUI [3])
C0264383 (UMLS CUI [4])
C3714636 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C0206063 (UMLS CUI [6,1])
C1882536 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Hepatitis B | Hepatitis C
Item
active hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Prior Therapy | CD137 agonists | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Pathway Targeting Agent
Item
prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
boolean
C1514463 (UMLS CUI [1])
C0214721 (UMLS CUI [2,1])
C0243192 (UMLS CUI [2,2])
C4289973 (UMLS CUI [3])
C4289970 (UMLS CUI [4])
C4289971 (UMLS CUI [5])
C0037080 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C1254351 (UMLS CUI [6,3])