A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

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