The preliminary results of observational study focused on clinical efficacy and safety of nivolumab (Nivo) treatment as >2™) line in patients with advanced refractory NSCLC as well as on quality of life (QoL) before and during treatment are presented. Patients and methods. Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w within the Expanded Access Program. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) — using NCI CTCAE v3.0. For QoL assessment pts completed RAND SF-36. For statistical analysis Mann-Whitney, Wilcoxon test and generalized estimating equations (GEE) were used. Overall survival (OS) and progression-free survival (PFS) were evaluated by the Kaplan-Meyer method. Results. The analysis was performed in the group of 176 NSCLC pts enrolled from 7 centers in RF. Median followup — 7.8 mos. Tumor control was confirmed in 59% patients. Median OS was 10.2 mos (95%CI: 6.6-13.7), median PFS — 4.2 mos (95%CI: 3.7-4.7). AEs were revealed in 34% patients; among them 13 (8%) patients with grade 3-4 AEs. Significant QoL impairment was identified in patients before Nivo treatment. Within 12 weeks after treatment start QoL improvement/ stabilization was revealed. Absence of tumor control at first tumor evaluation, poor ECOG, underweight and significant base-line QoL impairment are predictive for worse survival. Conclusion. The data obtained demonstrate satisfactory efficacy and safety of Nivo treatment as Z line in patients with advanced refractory NSCLC within the Expanded Access Program. Before Nivo treatment patients have significant QoL impairment; Nivo treatment leads to meaningful QoL improvement/stabilization in NSCLC pts.