A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 alani