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Objectives Unresectable stage III NSCLC (non–small cell lung cancer) confers a poor prognosis and interest is growing in the use of immunotherapy to improve outcomes for patients with this disease. We investigated the safety and efficacy of maintenance tecemotide, a mucin 1 (MUC1)-specific agent that induces T-cell responses to MUC1, versus placebo in Japanese patients with stage III unresectable NSCLC and no disease progression after primary chemoradiotherapy. Materials and methods Patients aged ≥20 years with unresectable stage III NSCLC, stable disease or clinical response after primary chemoradiotherapy and performance status ≤1, were recruited across 25 centers in Japan. Patients were randomized 2:1 to tecemotide (930 μg as lipopeptide) or placebo subcutaneously once weekly for 8 weeks, then every 6 weeks until disease progression or treatment withdrawal. Cyclophosphamide 300 mg/m 2 (maximum dose 600 mg) was given intravenously 3 days before the first dose of tecemotide. The primary endpoint was overall survival (OS). Secondary endpoints were progression–free survival, time to progression, time to treatment failure and safety. Results The intent–to–treat population comprised 172 patients; 114 received tecemotide and 58 placebo. Baseline characteristics were comparable between treatment arms. Most patients (94%) received primary concurrent chemoradiotherapy. There was no apparent trend toward increased OS time with tecemotide over placebo (median 32.4 versus 32.2 months, hazard ratio 0.95, 95% confidence interval 0.61–1.48; P = 0.83). No improvements in secondary efficacy endpoints were observed. The frequency of treatment–related adverse events was similar, and serious adverse event rates were the same in both arms. There were no new safety signals. Conclusions These results do not support those from a randomized phase III study (START) of improved OS with tecemotide in the subgroup of patients treated with primary concurrent chemoradiotherapy. [ABSTRACT FROM AUTHOR]