Overview
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.
Description
Bevacizumab is a monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Avastin®, which is approved as first line treatment in combination with carboplatin and paclitaxel for patients with unresectable, locally advanced, recurrent or metastatic non-squamous Non-Small Cell Lung Cancer. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
Eligibility
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 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 mutations
- Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed
- Major surgery 28 days before inclusion into the study
- Minor surgery 7 days before inclusion into the study
- Stage II or higher of neuropathy or ototoxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, excluding trauma
- Life expectancy less than 6 months
- Metastases to central nervous system or carcinomatous meningitis
- Pregnancy or lactation