ARIAN protocol: a phase III study of sacituzumab and zimberelimab for the treatment of patients with non-small cell lung cancer.

Lung cancer remains the leading cause of cancer-related deaths worldwide. Despite advances to improve treatment in resectable early-stage and locally advanced non-small cell lung cancer (NSCLC), survival rates after 5 years remain low, with a high risk of disease progression. Patients who fail to achieve a pathological complete response (pCR) after neoadjuvant treatment have unfavorable outcomes. ARIAN is a phase III, multicenter, open-label, randomized trial evaluating adjuvant treatment in adults with stage IB-IIIB (N2) NSCLC who have undergone neoadjuvant chemo-immunotherapy but did not achieve pCR after completing surgical resection. Patients will be stratified based on programmed death receptor-ligand 1 (PD-L1) tumor expression and randomized (1:1:1) to observation for 10 months (Arm 1), zimberelimab for 13 cycles (Arm 2), or sacituzumab govitecan and zimberelimab for 8 cycles followed by zimberelimab monotherapy for 5 cycles (Arm 3). The primary endpoint is disease-free survival, and secondary endpoints include overall survival and safety.