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:

1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
2. 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
3. Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
4. Adequate pulmonary and cardiac function to undergo surgical resection
5. Measurable disease as defined by RECIST v1.1
6. Adequate hematologic and end organ function
7. Negative HIV test at screening
8. Negative for active HBV and HCV at screening
9. Adequate tissue for PD-L1 IHC assessment

Exclusion criteria:

1. NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
2. Mixed NSCLC and small cell lung cancer histology
3. Any prior therapy for lung cancer
4. 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
5. Non-squamous NSCLC histology with activating ALK and EGFR mutation
6. Pregnant or lactating women
7. History of autoimmune disease
8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
9. 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
10. Severe infection within 4 weeks prior to randomization
11. Significant history of cardiovascular disease