International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer

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