RecruitingPhase 3NCT05654454

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

Sponsor

Mabscale, LLC

Enrollment

620 participants

Start Date

May 31, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a biosimilar version of bevacizumab (a cancer drug) to the original brand-name Avastin® when combined with standard chemotherapy (paclitaxel and carboplatin) for people with advanced or returning non-small cell lung cancer. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with or have recurring stage IIIB/C or stage IV non-small cell lung cancer (non-squamous type) - Your cancer has been confirmed by biopsy - You are well enough to carry out daily activities (ECOG performance status 0 or 1) - You have at least one measurable tumor - Your doctor has determined you are eligible for this combination chemotherapy regimen **You may NOT be eligible if...** - You have squamous cell lung cancer - Your general health status is too poor to receive chemotherapy - You do not have measurable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBevacizumab

Bevacizumab 15 mg/kg

DRUGPaclitaxel

Paclitaxel 175 mg/m2

DRUGCarboplatin

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

View Full Details on ClinicalTrials.gov

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NCT05654454