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

M

Mabscale

Status and phase

Enrolling
Phase 3

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05654454
BEV-III/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

620 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

620 participants in 2 patient groups

Bevacizumab with Paclitaxel and Carboplatin
Experimental group
Description:
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.
Treatment:
Drug: Paclitaxel
Drug: Carboplatin
Drug: Bevacizumab
Avastin® with Paclitaxel and Carboplatin
Active Comparator group
Description:
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.
Treatment:
Drug: Paclitaxel
Drug: Carboplatin
Drug: Bevacizumab

Trial contacts and locations

28

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Central trial contact

Alexander Generalov, MD

Data sourced from clinicaltrials.gov

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