NCT05654454 A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
| NCT ID | NCT05654454 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mabscale, LLC |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 620 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 620 participants in total. It began in 2023-05-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05654454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05654454 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 620 participants.
Is NCT05654454 currently recruiting?
Yes, NCT05654454 is actively recruiting participants. Contact the research team at generalov.a@benerix.ru for enrollment information.
Where is the NCT05654454 trial being conducted?
This trial is being conducted at Arkhangelsk, Russia, Ivanovo, Russia, Kaluga, Russia, Kazan', Russia and 11 additional locations.
Who is sponsoring the NCT05654454 clinical trial?
NCT05654454 is sponsored by Mabscale, LLC. The trial plans to enroll 620 participants.
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