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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
620

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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