A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
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
Mabscale, LLC
620 participants
May 31, 2023
INTERVENTIONAL
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 Criteria13
- 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 Criteria8
- 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
Interventions
Bevacizumab 15 mg/kg
Paclitaxel 175 mg/m2
Carboplatin AUC 6
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05654454