A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

Inclusion Criteria:

• ECOG performance status of 0 or 1.

• Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC.

• No prior treatment for Stage IV non-squamous or squamous NSCLC.

• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy,or chemo-radiotherapy with curative intent for non-metastatic disease must haveexperienced a treatment free interval of at least 6 months from enrollment since thelast chemotherapy, radiotherapy, or chemo-radiotherapy cycle.

• Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory onpreviously obtained archival tumor tissue or tissue obtained from a biopsy atscreening.

• Measurable disease, as defined by RECIST v1.1.

• Adequate hematologic and end-organ function.

• Life expectancy ≥3 months.

• For women of childbearing potential: agreement to remain abstinent or usecontraception, and agreement to refrain from donating.

Exclusion Criteria:

• Known sensitizing mutation in the EGFR gene or ALK fusion oncogene.

• Symptomatic, untreated, or actively progressing CNS metastases.

• Spinal cord compression not definitively treated with surgery and/or radiation, orpreviously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for ≥2 weeks prior to enrollment.

• Current leptomeningeal disease.

• Uncontrolled tumor-related pain.

• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures.

• Uncontrolled or symptomatic hypercalcemia.

• Malignancies other than NSCLC within 5 years prior to enrollment, with the exceptionof those with a negligible risk of metastasis or death treated with expectedcurative outcome.

• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatmentor within at least 5 months after the last dose of atezolizumab.

• History of severe allergic, anaphylactic, or other hypersensitivity reactions tochimeric or humanized antibodies or fusion proteins.

• Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamsterovary cells or any component of the atezolizumab formulation.

• Active or history of autoimmune disease or immune deficiency.

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screeningchest CT scan.

• Positive human immunodeficiency virus (HIV) test result at screening.

• Patients with active hepatitis B or active hepatitis C at screening.

• Active tuberculosis.

• Severe infections within 4 weeks prior to randomization, including, but not limitedto, hospitalization for complications of infection, bacteremia, or severe pneumonia.

• Significant cardiovascular disease.