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Limited treatment options are available for stage  IIIB / IV  non‐small cell lung cancer ( NSCLC ). Nivolumab, a programmed cell death‐1 immune checkpoint inhibitor antibody, has been shown to be effective for the treatment of  NSCLC . The present study investigated the effectiveness and safety of nivolumab in Japanese patients with advanced or recurrent squamous  NSCLC  that progressed after platinum‐containing chemotherapy. In this multicenter phase  II  study, patients were treated with nivolumab (3 mg/kg, i.v.) every 2 weeks until progressive disease or unacceptable toxicity was seen. Primary endpoint was overall response rate ( ORR ) assessed by independent radiology review committee ( IRC ) and secondary endpoints included a study site‐assessed  ORR , overall survival ( OS ), progression‐free survival ( PFS ), duration of response, time to response, best overall response ( BOR ), and safety. The study included 35 patients from 17 sites in Japan. Patients had  IRC ‐assessed  ORR  of 25.7% (95%  CI  14.2, 42.1) and the study site‐assessed  ORR  was 20.0% (95%  CI  10.0, 35.9). Median  OS , median time to response and median  PFS  were 16.3 (95%  CI  12.4–25.4), 2.7 (range 1.2–5.5) and 4.2 (95%  CI  1.4–7.1) months, respectively. The  IRC ‐assessed  BOR  was partial response, stable disease, and progressive disease for 25.7%, 28.6%, and 45.7% of patients, respectively. Treatment‐related adverse events were reported in 24 patients (68.6%), most of which resolved with appropriate treatment including steroid therapy or discontinuation of nivolumab. Nivolumab was effective and well tolerated in Japanese patients with advanced or recurrent squamous  NSCLC  that progressed after platinum‐containing chemotherapy. Clinical trial registration number: Japic CTI ‐132072

Efficacy and safety of nivolumab in Japanese patients with advanced or recurrent squamous non‐small cell lung cancer