Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

Inclusion Criteria: * Verified diagnosis of non-small cell lung cancer * Verified progression of the disease after or during first-line chemotherapy based on platinum drugs * Absence of mutation of EGFR and ALK genes * ECOG score 0-1 * At least one lesion, that is measurable according to RECIST 1.1 criteria * Absence of severe organ pathology * Anticipated live duration more that 12 weeks after screening * Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs Exclusion Criteria: * EGFR and/or ALK mutations * Patients with severe of live-threatening acute complications of the disease * Intersticial lung diseases or pneumonitis * Concomitant diseases that affect safety evaluation * Autoimmune diseases * Endocrine diseases that could not be compensated by hormonal therapy * Patient needs glucocorticoids * Significant liver or renal diseases * Lactate dehydrogenase exceeds upper limit of normal more that 2-fold * More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment * Anti-tumor treatment ending less then 28 days before screening * Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs * Prior therapy with docetaxel * Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma * Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel * Pregnancy and lactation