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

Recruiting now · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05654454

Run by

Mabscale, LLC

People needed

620

Starts

2023-05-31

Expected to finish

2027-03-01

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Regional Clinical Oncological Hospital — Yaroslavl, Russia (enrolling)
• State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary — Ivanovo, Russia (enrolling)
• Kaluga Regional Clinical Oncology Dispensary — Kaluga, Russia (enrolling)
• Regional clinical oncological dispensary n.a.Sigal — Kazan', Russia (enrolling)
• Burdenko Main Military Clinical Hospital — Moscow, Russia (enrolling)
• Medical University "Reaviz" — Samara, Russia (enrolling)
• Smolensk oncologic dispensary — Smolensk, Russia (enrolling)
• Smolensk Regional Clinical Hospital — Smolensk, Russia (enrolling)
• Tverskoy Regional Oncological Dispensary — Tver', Russia (enrolling)
• Volgograd Regional Clinical Oncology Dispensary — Volgograd, Russia (enrolling)
• Arkhangelsk Clinical Oncological Dispensary — Arkhangelsk, Russia (enrolling)
• Murmansk Regional Clinical Hospital — Murmansk, Russia (enrolling)
• Nizhny Novgorod Regional Oncology Dispensary — Nizhny Novgorod, Russia (enrolling)
• Novosibirsk oncologic dispensary — Novosibirsk, Russia (enrolling)
• Omsk clinical oncologic dispensary — Omsk, Russia (enrolling)
• Euromedservice medical center — Pushkin, Russia (enrolling)
• Clinical Hospital RZD-Medicine — Saint Petersburg, Russia (enrolling)
• Euro Cityclinic — Saint Petersburg, Russia (enrolling)
• Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman) — Saint Petersburg, Russia (enrolling)
• Leningrad regional clinical hospital — Saint Petersburg, Russia (enrolling)
• National Medical Research Center of Oncology N.A. N.N. Petrov — Saint Petersburg, Russia (enrolling)
• Northwestern Center for Evidence-Based Medicine — Saint Petersburg, Russia (enrolling)
• Hadassah Medical Moscow — Moscow, Russia
• National Medical Oncology Research Center n.a. N.N. Blokhina — Moscow, Russia
• Perm Edge Clinical Hospital — Perm, Russia

Full record on ClinicalTrials.gov

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