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

NCT05654454 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2024-08-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab 15 mg/kg

DRUG

Paclitaxel

Paclitaxel 175 mg/m2

DRUG

Carboplatin

Carboplatin AUC 6

Sponsors & Collaborators

  • Mabscale, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654454 on ClinicalTrials.gov