Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of Bevacizumab (Mabscale LLC, Russia) + Paclitaxel + Carboplatin to Avastin® + Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer
BEV-III/2022 is a double-blind randomized multicenter clinical trial comparing efficacy of bevacizumab (manufactured by Mabscale, LLC) and paclitaxel plus carboplatin to Avastin® and paclitaxel plus carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC. The purpose of the study is to demonstrate equivalence of efficacy and safety of bevacizumab (manufactured by Mabscale, LLC) to Avastin®. Study includes pharmacokinetics assessment.
• Written informed consent
• Male and female patients at least 18 years of age
• Newly diagnosed Stage IIIB/C or IV non-small cell lung cancer (according to Revised Cancer Staging by American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) 8th edition) or recurrent non-small cell lung cancer (NSCLC)
• Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC
• Presence of at least 1 measurable tumour as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Neutrophils ≥ 1,5 × 10\^9/L
• Platelets ≥ 100 × 10\^9/L
• Haemoglobin ≥ 90 g/L
• Bilirubin level ≤ 1.5 × upper limit of normal (ULN)
• Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) levels \< 3 × ULN (\< 5 × ULN for patients with liver metastases)
• Alkaline phosphatase level \< 3 × ULN (\< 5 × ULN for patients with liver or bone metastases)