- Trial ID:
- Michael Kosty
Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system - Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent - Adequate pulmonary and cardiac function to undergo surgical resection - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and end organ function - Negative HIV test at screening - Negative for active HBV and HCV at screening - Adequate tissue for PD-L1 IHC assessment Exclusion criteria: - NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma - Mixed NSCLC and small cell lung cancer histology - Any prior therapy for lung cancer - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome - Non-squamous NSCLC histology with activating ALK and EGFR mutation - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan - Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody - Severe infection within 4 weeks prior to randomization - Significant history of cardiovascular disease
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