A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Recruiting · NCT05654454 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
28 locations listed.
- 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
- Nizhny Novgorod Regional Oncology Dispensary - Nizhny Novgorod, Russia
- Novosibirsk oncologic dispensary - Novosibirsk, Russia
- Omsk clinical oncologic dispensary - Omsk, Russia
- Perm Edge Clinical Hospital - Perm, Russia
- Perm Regional Clinical Hospital - Perm, Russia
- Euromedservice medical center - Pushkin, Russia
- Clinical Hospital RZD-Medicine - Saint Petersburg, Russia
- Euro Cityclinic - Saint Petersburg, Russia
- Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman) - Saint Petersburg, Russia
- Leningrad regional clinical hospital - Saint Petersburg, Russia
- National Medical Research Center of Oncology N.A. N.N. Petrov - Saint Petersburg, Russia
- Northwestern Center for Evidence-Based Medicine - Saint Petersburg, Russia
- Medical University "Reaviz" - Samara, Russia
- Smolensk oncologic dispensary - Smolensk, Russia
- Smolensk Regional Clinical Hospital - Smolensk, Russia
- Tverskoy Regional Oncological Dispensary - Tver', Russia
- Bashkir State Medical University - Ufa, Russia
- Oblastnoy Clinical Oncological Dispansery - Veliky Novgorod, Russia
- Volgograd Regional Clinical Oncology Dispensary - Volgograd, Russia
- Regional Clinical Oncological Hospital - Yaroslavl, Russia