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Comparing a new version of Bevacizumab with Avastin for lung cancer treatment

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

Phase 3 Interventional Mabscale, LLC · NCT05654454

This study is testing a new version of a lung cancer drug called bevacizumab to see if it works as well and is just as safe as the current drug Avastin when used with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment620 (estimated)
Ages18 Years and up
SexAll
SponsorMabscale, LLC Industry-sponsored
Drugs / interventionsbevacizumab
Locations28 sites (Arkhangelsk and 27 other locations)
Trial IDNCT05654454 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, randomized, multicenter study that evaluates the safety and efficacy of a new version of bevacizumab, developed by Mabscale, LLC, compared to the established drug Avastin® in combination with paclitaxel and carboplatin for treating advanced non-squamous non-small cell lung cancer (NSCLC). The study aims to demonstrate that the new bevacizumab is equivalent in effectiveness and safety to Avastin®. Participants will undergo pharmacokinetics assessments to further understand the drug's behavior in the body.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or recurrent stage IIIB/C or IV non-squamous NSCLC.

Not a fit: Patients with squamous cell lung cancer or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective and potentially more affordable treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Previous studies have shown success with similar biosimilar approaches, indicating potential for this trial's success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Arkhangelsk and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.