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

RecruitingPhase 3Ages 18 Years - anyAllMabscale, LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Bevacizumab
  • Paclitaxel
  • Carboplatin
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Where

28 sites
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Kaluga Regional Clinical Oncology Dispensary
Kaluga, Russia
Regional clinical oncological dispensary n.a.Sigal
Kazan', Russia
Burdenko Main Military Clinical Hospital
Moscow, Russia
Hadassah Medical Moscow
Moscow, Russia
National Medical Oncology Research Center n.a. N.N. Blokhina
Moscow, Russia
Murmansk Regional Clinical Hospital
Murmansk, Russia

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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