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

August 15, 2024 updated by: Mabscale, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Recruiting
        • Arkhangelsk Clinical Oncological Dispensary
        • Contact:
          • Chapko
      • Ivanovo, Russian Federation
        • Recruiting
        • State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
        • Contact:
          • Ponomareva
      • Kaluga, Russian Federation
        • Recruiting
        • Kaluga Regional Clinical Oncology Dispensary
        • Contact:
          • Kudryavtsev
      • Kazan', Russian Federation
        • Recruiting
        • Regional clinical oncological dispensary n.a.Sigal
        • Contact:
          • Safin
      • Moscow, Russian Federation
        • Not yet recruiting
        • National Medical Oncology Research Center n.a. N.N. Blokhina
        • Contact:
          • Breder
      • Moscow, Russian Federation
        • Recruiting
        • Burdenko Main Military Clinical Hospital
        • Contact:
          • Smolin
      • Moscow, Russian Federation
        • Withdrawn
        • Hadassah Medical Moscow
      • Murmansk, Russian Federation
        • Recruiting
        • Murmansk Regional Clinical Hospital
        • Contact:
          • Korelskaya
      • Nizhny Novgorod, Russian Federation
        • Recruiting
        • Nizhny Novgorod Regional Oncology Dispensary
        • Contact:
          • Matrosova
      • Novosibirsk, Russian Federation
        • Recruiting
        • Novosibirsk oncologic dispensary
        • Contact:
          • Kozlov
      • Omsk, Russian Federation
        • Recruiting
        • Omsk clinical oncologic dispensary
        • Contact:
          • Zimina
      • Perm, Russian Federation
        • Not yet recruiting
        • Perm Regional Clinical Hospital
        • Contact:
          • Trefilova
      • Perm, Russian Federation
        • Not yet recruiting
        • Perm Edge Clinical Hospital
        • Contact:
          • Trefilova
      • Pushkin, Russian Federation
        • Recruiting
        • Euromedservice medical center
        • Contact:
          • Pen'kov
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Euro Cityclinic
        • Contact:
          • Orlov
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
        • Contact:
          • Belogortsev
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Leningrad Regional Clinical Hospital
        • Contact:
          • Smagina
      • Saint Petersburg, Russian Federation
        • Recruiting
        • National Medical Research Center of Oncology N.A. N.N. Petrov
        • Contact:
          • Poltoratsky
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Northwestern Center for Evidence-Based Medicine
        • Contact:
          • Schmelev
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Clinical Hospital RZD-Medicine
        • Contact:
          • Vasiliev
      • Samara, Russian Federation
        • Recruiting
        • Medical University "Reaviz"
        • Contact:
          • Kopp
      • Smolensk, Russian Federation
        • Recruiting
        • Smolensk Regional Clinical Hospital
        • Contact:
          • Haykin
      • Smolensk, Russian Federation
        • Recruiting
        • Smolensk oncologic dispensary
        • Contact:
          • Povaga
      • Tver, Russian Federation
        • Recruiting
        • Tverskoy Regional Oncological Dispensary
        • Contact:
          • Dergunov
      • Ufa, Russian Federation
        • Not yet recruiting
        • Bashkir State Medical University
        • Contact:
          • Sakaeva
      • Veliki Nóvgorod, Russian Federation
        • Not yet recruiting
        • Oblastnoy Clinical Oncological Dispansery
        • Contact:
          • Mancirev
      • Volgograd, Russian Federation
        • Recruiting
        • Volgograd Regional Clinical Oncology Dispensary
        • Contact:
          • Kovalenko
      • Yaroslavl, Russian Federation
        • Recruiting
        • Regional Clinical Oncological Hospital
        • Contact:
          • Belonogov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Bilirubin level ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) levels < 3 × ULN (< 5 × ULN for patients with liver metastases)
  • Alkaline phosphatase level < 3 × ULN (< 5 × ULN for patients with liver or bone metastases)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab with Paclitaxel and Carboplatin

Patients will begin Period 1 receiving bevacizumab combination therapy (Bevacizumab 15 mg/kg IV + Paclitaxel 175 mg/m2 + IV Carboplatin AUC 6 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (produced by Mabscale, LLC).

In Period 2, eligible patients will continue to receive bevacizumab (produced by Mabscale, LLC) every 3 weeks as monotherapy.
Drug: Bevacizumab
Bevacizumab 15 mg/kg
Drug: Paclitaxel
Paclitaxel 175 mg/m2
Drug: Carboplatin
Carboplatin AUC 6
Active Comparator: Avastin® with Paclitaxel and Carboplatin

Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin® 15 mg/kg IV + Paclitaxel 175 mg/m2 IV + Carboplatin AUC 6 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin®).

In Period 2, eligible patients will continue to receive bevacizumab (Avastin®) every 3 weeks as monotherapy.
Drug: Bevacizumab
Bevacizumab 15 mg/kg
Drug: Paclitaxel
Paclitaxel 175 mg/m2
Drug: Carboplatin
Carboplatin AUC 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) at Week 18
Time Frame: 18 weeks from randomisation
Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).
18 weeks from randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: At week 18 and 42 from randomisation
Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.
At week 18 and 42 from randomisation
Overall Survival (OS)
Time Frame: At week 18 and 42 from randomisation
Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
At week 18 and 42 from randomisation
Duration of response (DOR)
Time Frame: 48 weeks
Duration of responce was defined as the time from responce to treatment till progression or death.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabscale, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEV-III/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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