A Phase II Study of Nivolumab in Patients With Advanced Non–small-cell Lung Cancer who Responded to Prior PD-1/L1 Inhibitors: West Japan Oncology Group 9616L (WJOG9616L)

Immune-checkpoint inhibitors (ICIs) play an important role in treatment for advanced non-small-cell lung cancer. Over one-half of patients, however, have relapse. Although rechallenge treatment of anti-cancer drugs that showed efficacy in prior lines of therapy has been broadly accepted in lung cancer, evidence of efficacy of rechallenge of ICIs has been limited to anecdotal case series. We therefore plan a phase II study. The primary endpoint is to assess the overall response rate of nivolumab in patients with advanced non-small-cell lung cancer who responded to prior ICIs. Secondary endpoints are disease control rate, progression-free survival, overall survival, and safety. Sixty patients will be enrolled in this trial. Programmed death-ligand 1 expression level in circulating tumor cells will be evaluated as a surrogate biomarker for the prediction of the efficacy.