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RECRUITING
NCT05654454
PHASE3

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

Sponsor: Mabscale, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Bevacizumab

Bevacizumab 15 mg/kg

DRUG

Paclitaxel

Paclitaxel 175 mg/m2

DRUG

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