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

A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

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 have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle.
• Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
• 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 use contraception, 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, or previously diagnosed and treated spinal cord compression without evidence that disease 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 recurrent drainage procedures.
• Uncontrolled or symptomatic hypercalcemia.
• Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary 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-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest 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 limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• Significant cardiovascular disease.