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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
620
Bevacizumab 15 mg/kg
Paclitaxel 175 mg/m2
Carboplatin AUC 6
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
RECRUITINGState Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
RECRUITINGKaluga Regional Clinical Oncology Dispensary
Kaluga, Russia
RECRUITINGRegional clinical oncological dispensary n.a.Sigal
Kazan', Russia
Objective Response Rate (ORR) at Week 18
Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).
Time frame: 18 weeks from randomisation
Progression-free Survival (PFS)
Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.
Time frame: At week 18 and 42 from randomisation
Overall Survival (OS)
Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
Time frame: At week 18 and 42 from randomisation
Duration of response (DOR)
Duration of responce was defined as the time from responce to treatment till progression or death.
Time frame: 48 weeks
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Burdenko Main Military Clinical Hospital
Moscow, Russia
RECRUITINGHadassah Medical Moscow
Moscow, Russia
WITHDRAWNNational Medical Oncology Research Center n.a. N.N. Blokhina
Moscow, Russia
NOT_YET_RECRUITINGMurmansk Regional Clinical Hospital
Murmansk, Russia
RECRUITINGNizhny Novgorod Regional Oncology Dispensary
Nizhny Novgorod, Russia
RECRUITINGNovosibirsk oncologic dispensary
Novosibirsk, Russia
RECRUITING...and 18 more locations