Clinical trial NCT05654454: A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Mabscale, LLC
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Bevacizumab is a monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Avastin®, which is approved as first line treatment in combination with carboplatin and paclitaxel for patients with unresectable, locally advanced, recurrent or metastatic non-squamous Non-Small Cell Lung Cancer. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

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

Primary outcomes:
measure: Objective Response Rate (ORR) at Week 18
timeFrame: 18 weeks from randomisation
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: At week 18 and 42 from randomisation
measure: Overall Survival (OS)
timeFrame: At week 18 and 42 from randomisation
measure: Duration of response (DOR)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
city: Ivanovo
country: Russian Federation
facility: State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Dispensary
city: Kazan'
country: Russian Federation
facility: Regional clinical oncological dispensary n.a.Sigal
city: Moscow
country: Russian Federation
facility: Burdenko Main Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Hadassah Medical Moscow
city: Moscow
country: Russian Federation
facility: National Medical Oncology Research Center n.a. N.N. Blokhina
city: Murmansk
country: Russian Federation
facility: Murmansk Regional Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Oncology Dispensary
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk oncologic dispensary
city: Omsk
country: Russian Federation
facility: Omsk clinical oncologic dispensary
city: Perm
country: Russian Federation
facility: Perm Edge Clinical Hospital
city: Perm
country: Russian Federation
facility: Perm Regional Clinical Hospital
city: Pushkin
country: Russian Federation
facility: Euromedservice medical center
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital RZD-Medicine
city: Saint Petersburg
country: Russian Federation
facility: Euro Cityclinic
city: Saint Petersburg
country: Russian Federation
facility: Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
city: Saint Petersburg
country: Russian Federation
facility: Leningrad regional clinical hospital
city: Saint Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov
city: Saint Petersburg
country: Russian Federation
facility: Northwestern Center for Evidence-Based Medicine
city: Samara
country: Russian Federation
facility: Medical University "Reaviz"
city: Smolensk
country: Russian Federation
facility: Smolensk oncologic dispensary
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Tver
country: Russian Federation
facility: Tverskoy Regional Oncological Dispensary
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Veliki Nóvgorod
country: Russian Federation
facility: Oblastnoy Clinical Oncological Dispansery
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncological Hospital
Study officials:
References: