Actively Recruiting
A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Led by Mabscale, LLC · Updated on 2024-08-16
620
Participants Needed
28
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be male or female aged 18 years or older
- Have newly diagnosed or recurrent Stage IIIB/C or IV non-small cell lung cancer
- Have a confirmed diagnosis of predominantly non-squamous NSCLC
- Have an ECOG performance status of 0 or 1
- Be eligible for treatment with bevacizumab, paclitaxel, and carboplatin
- Have at least one measurable tumor per RECIST 1.1 criteria
- Have neutrophil count 21 1.5 �d7 10^9/L
- Have platelet count 21 100 �d7 10^9/L
- Have hemoglobin level 21 90 g/L
- Have bilirubin level 4 1.5 times the upper limit of normal
- Have AST and ALT levels < 3 times the upper limit of normal (< 5 times if liver metastases present)
- Have alkaline phosphatase level < 3 times the upper limit of normal (< 5 times if liver or bone metastases present)
You will not qualify if you...
- Have known sensitizing EGFR mutations or ALK positive translocations
- Have tumors compressing or invading major blood vessels or tumor cavitation likely to bleed
- Have had major surgery within 28 days before study entry
- Have had minor surgery within 7 days before study entry
- Have Stage II or higher neuropathy or ototoxicity (excluding trauma)
- Have a life expectancy less than 6 months
- Have metastases to the central nervous system or carcinomatous meningitis
- Are pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
Actively Recruiting
2
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Actively Recruiting
3
Kaluga Regional Clinical Oncology Dispensary
Kaluga, Russia
Actively Recruiting
4
Regional clinical oncological dispensary n.a.Sigal
Kazan', Russia
Actively Recruiting
5
Burdenko Main Military Clinical Hospital
Moscow, Russia
Actively Recruiting
6
Hadassah Medical Moscow
Moscow, Russia
Withdrawn
7
National Medical Oncology Research Center n.a. N.N. Blokhina
Moscow, Russia
Not Yet Recruiting
8
Murmansk Regional Clinical Hospital
Murmansk, Russia
Actively Recruiting
9
Nizhny Novgorod Regional Oncology Dispensary
Nizhny Novgorod, Russia
Actively Recruiting
10
Novosibirsk oncologic dispensary
Novosibirsk, Russia
Actively Recruiting
11
Omsk clinical oncologic dispensary
Omsk, Russia
Actively Recruiting
12
Perm Edge Clinical Hospital
Perm, Russia
Not Yet Recruiting
13
Perm Regional Clinical Hospital
Perm, Russia
Not Yet Recruiting
14
Euromedservice medical center
Pushkin, Russia
Actively Recruiting
15
Clinical Hospital RZD-Medicine
Saint Petersburg, Russia
Actively Recruiting
16
Euro Cityclinic
Saint Petersburg, Russia
Actively Recruiting
17
Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
Saint Petersburg, Russia
Actively Recruiting
18
Leningrad regional clinical hospital
Saint Petersburg, Russia
Actively Recruiting
19
National Medical Research Center of Oncology N.A. N.N. Petrov
Saint Petersburg, Russia
Actively Recruiting
20
Northwestern Center for Evidence-Based Medicine
Saint Petersburg, Russia
Actively Recruiting
21
Medical University "Reaviz"
Samara, Russia
Actively Recruiting
22
Smolensk oncologic dispensary
Smolensk, Russia
Actively Recruiting
23
Smolensk Regional Clinical Hospital
Smolensk, Russia
Actively Recruiting
24
Tverskoy Regional Oncological Dispensary
Tver', Russia
Actively Recruiting
25
Bashkir State Medical University
Ufa, Russia
Not Yet Recruiting
26
Oblastnoy Clinical Oncological Dispansery
Veliky Novgorod, Russia
Not Yet Recruiting
27
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russia
Actively Recruiting
28
Regional Clinical Oncological Hospital
Yaroslavl, Russia
Actively Recruiting
Research Team
A
Alexander Generalov, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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