A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
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
1 other identifier
interventional
620
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started May 2023
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
August 16, 2024
August 1, 2024
3.5 years
December 8, 2022
August 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) at Week 18
Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).
18 weeks from randomisation
Secondary Outcomes (3)
Progression-free Survival (PFS)
At week 18 and 42 from randomisation
Overall Survival (OS)
At week 18 and 42 from randomisation
Duration of response (DOR)
48 weeks
Study Arms (2)
Bevacizumab with Paclitaxel and Carboplatin
EXPERIMENTALPatients will begin Period 1 receiving bevacizumab combination therapy (Bevacizumab 15 mg/kg IV + Paclitaxel 175 mg/m2 + IV Carboplatin AUC 6 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (produced by Mabscale, LLC). In Period 2, eligible patients will continue to receive bevacizumab (produced by Mabscale, LLC) every 3 weeks as monotherapy.
Avastin® with Paclitaxel and Carboplatin
ACTIVE COMPARATORPatients will begin Period 1 receiving bevacizumab combination therapy ( Avastin® 15 mg/kg IV + Paclitaxel 175 mg/m2 IV + Carboplatin AUC 6 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin®). In Period 2, eligible patients will continue to receive bevacizumab (Avastin®) every 3 weeks as monotherapy.
Interventions
Bevacizumab 15 mg/kg
Paclitaxel 175 mg/m2
Carboplatin AUC 6
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mabscale, LLClead
Study Sites (28)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2022
First Posted
December 16, 2022
Study Start
May 31, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
August 16, 2024
Record last verified: 2024-08