a study of atezolizumab in high pd-l1 expression, chemotherapy-naïve patients with stage iv non-squamous or squamous non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: 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.


Eligibility criteria:
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.