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RECRUITINGPHASE3

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

NCT05654454•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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent
•Male and female patients at least 18 years of age
•Newly diagnosed Stage IIIB/C or IV non-small cell lung cancer (according to Revised Cancer Staging by American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) 8th edition) or recurrent non-small cell lung cancer (NSCLC)
•Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC
•Presence of at least 1 measurable tumour as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
•Neutrophils ≥ 1,5 × 10\^9/L
•Platelets ≥ 100 × 10\^9/L
•Haemoglobin ≥ 90 g/L
+3 more criteria

Exclusion Criteria

•Known sensitizing EGFR mutations or ALK translocation positive mutations
•Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed
•Major surgery 28 days before inclusion into the study
•Minor surgery 7 days before inclusion into the study
•Stage II or higher of neuropathy or ototoxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, excluding trauma
•Life expectancy less than 6 months
•Metastases to central nervous system or carcinomatous meningitis
•Pregnancy or lactation

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

Key Dates

Start Date

May 31, 2023

Primary Completion Date

December 1, 2026

Completion Date

March 1, 2027

Last Updated

August 16, 2024

Enrollment

620

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Bevacizumab

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

Contacts

Alexander Generalov, MD

CONTACT

+74997149289 generalov.a@benerix.ru

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)