A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer

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

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

Conditions3

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