In recent years, immunotherapy has become an innovative technology for cancer therapy with the discovery of immunological checkpoints. It has shown great potential in a variety of advanced cancer treatments. Particularly, significant progress has been achieved in the understanding of programmed death-1/programmed death ligand-1 (PD-1/ PD-L1) pathway. Nivolumab, a human immunoglobulin (Ig)G4 PD-1 monoclonal antibody, was the first PD-1 inhibitor approved in the treatment of advanced non–small-cell lung cancer (NSCLC). Nivolumab has become a mainstay of first-line treatment of advanced/metastatic NSCLC without targetable genetic alterations. However, there are some questions in clinic that lacking of identifying biomarkers to predict the PD-1 immune checkpoint inhibition response. In this review, we summarize the results from recent clinical trials that have evaluated the nivolumab as first- or second- line treatment as monotherapy, in combination with chemotherapy and other immunotherapies. Also, we discuss the function of potential predicted biomarkers such as PD-L1 expression and tumor mutation burden in cancer treatment.