A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in 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.

Inclusion Criteria:Written informed consentMale and female patients at least 18 years of ageNewly 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 NSCLCEastern Cooperative Oncology Group (ECOG) performance status 0 or 1Be 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 NSCLCPresence of at least 1 measurable tumour as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)Neutrophils ≥ 1,5 × 10^9/LPlatelets ≥ 100 × 10^9/LHaemoglobin ≥ 90 g/LBilirubin 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)Exclusion Criteria:Known sensitizing EGFR mutations or ALK translocation positive mutationsEvidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleedMajor surgery 28 days before inclusion into the studyMinor surgery 7 days before inclusion into the studyStage II or higher of neuropathy or ototoxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, excluding traumaLife expectancy less than 6 monthsMetastases to central nervous system or carcinomatous meningitisPregnancy or lactation