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A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Sponsor: Mabscale, LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
620
Start Date
2023-05-31
Completion Date
2027-03
Last Updated
2024-08-16
Healthy Volunteers
No
Conditions
Interventions
Bevacizumab
Bevacizumab 15 mg/kg
Paclitaxel
Paclitaxel 175 mg/m2
Carboplatin
Carboplatin AUC 6
Locations (28)
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Kaluga Regional Clinical Oncology Dispensary
Kaluga, Russia
Regional clinical oncological dispensary n.a.Sigal
Kazan', Russia
Burdenko Main Military Clinical Hospital
Moscow, Russia
Hadassah Medical Moscow
Moscow, Russia
National Medical Oncology Research Center n.a. N.N. Blokhina
Moscow, Russia
Murmansk Regional Clinical Hospital
Murmansk, Russia
Nizhny Novgorod Regional Oncology Dispensary
Nizhny Novgorod, Russia
Novosibirsk oncologic dispensary
Novosibirsk, Russia
Omsk clinical oncologic dispensary
Omsk, Russia
Perm Edge Clinical Hospital
Perm, Russia
Perm Regional Clinical Hospital
Perm, Russia
Euromedservice medical center
Pushkin, Russia
Clinical Hospital RZD-Medicine
Saint Petersburg, Russia
Euro Cityclinic
Saint Petersburg, Russia
Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
Saint Petersburg, Russia
Leningrad regional clinical hospital
Saint Petersburg, Russia
National Medical Research Center of Oncology N.A. N.N. Petrov
Saint Petersburg, Russia
Northwestern Center for Evidence-Based Medicine
Saint Petersburg, Russia
Medical University "Reaviz"
Samara, Russia
Smolensk oncologic dispensary
Smolensk, Russia
Smolensk Regional Clinical Hospital
Smolensk, Russia
Tverskoy Regional Oncological Dispensary
Tver', Russia
Bashkir State Medical University
Ufa, Russia
Oblastnoy Clinical Oncological Dispansery
Veliky Novgorod, Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russia
Regional Clinical Oncological Hospital
Yaroslavl, Russia