A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
NCT05654454 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620
Last updated 2024-08-16
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.
Conditions
Interventions
- DRUG
-
Bevacizumab 15 mg/kg
- DRUG
-
Paclitaxel 175 mg/m2
- DRUG
-
Carboplatin AUC 6
Sponsors & Collaborators
-
Mabscale, LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-31
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
Countries
- Russia
Study Locations
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