Non-Small Cell Lung CancerPhase 3NCT05654454

A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Mabscale, LLC at 28 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Bevacizumab, Paclitaxel and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 620 participants
Where: 28 sitesRussia
Study dates: 31 May 2023to Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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)

Who cannot join

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

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Generalov, MD contact

+74997149289

generalov.a@benerix.ru

City, postcode or hospital

Sites recruiting now only

28 sites in 1 country

Russia28 sites, 27 recruiting

Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk
Chapko
Recruiting
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo
Ponomareva
Recruiting
Kaluga Regional Clinical Oncology Dispensary
Kaluga
Kudryavtsev
Recruiting
Regional clinical oncological dispensary n.a.Sigal
Kazan'
Safin
Recruiting
Burdenko Main Military Clinical Hospital
Moscow
Smolin
Recruiting
Hadassah Medical Moscow
Moscow
Withdrawn
National Medical Oncology Research Center n.a. N.N. Blokhina
Moscow
Breder
Not yet recruiting
Murmansk Regional Clinical Hospital
Murmansk
Korelskaya
Recruiting
Nizhny Novgorod Regional Oncology Dispensary
Nizhny Novgorod
Matrosova
Recruiting
Novosibirsk oncologic dispensary
Novosibirsk
Kozlov
Recruiting
Omsk clinical oncologic dispensary
Omsk
Zimina
Recruiting
Perm Edge Clinical Hospital
Perm
Trefilova
Not yet recruiting
Perm Regional Clinical Hospital
Perm
Trefilova
Not yet recruiting
Euromedservice medical center
Pushkin
Pen'kov
Recruiting
Clinical Hospital RZD-Medicine
Saint Petersburg
Vasiliev
Recruiting
Euro Cityclinic
Saint Petersburg
Orlov
Recruiting
Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
Saint Petersburg
Belogortsev
Recruiting
Leningrad regional clinical hospital
Saint Petersburg
Smagina
Recruiting
National Medical Research Center of Oncology N.A. N.N. Petrov
Saint Petersburg
Poltoratsky
Recruiting
Northwestern Center for Evidence-Based Medicine
Saint Petersburg
Schmelev
Recruiting
Medical University "Reaviz"
Samara
Kopp
Recruiting
Smolensk oncologic dispensary
Smolensk
Povaga
Recruiting
Smolensk Regional Clinical Hospital
Smolensk
Haykin
Recruiting
Tverskoy Regional Oncological Dispensary
Tver'
Dergunov
Recruiting
Bashkir State Medical University
Ufa
Sakaeva
Not yet recruiting
Oblastnoy Clinical Oncological Dispansery
Velikiy Novgorod
Mancirev
Not yet recruiting
Volgograd Regional Clinical Oncology Dispensary
Volgograd
Kovalenko
Recruiting
Regional Clinical Oncological Hospital
Yaroslavl
Belonogov
Recruiting

Other trials in Russia

About this study

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

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.

Read the 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.

Conditions: Non-Small Cell Lung Cancer
Being tested: Bevacizumab, Paclitaxel, Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BevacizumabDrug
Bevacizumab 15 mg/kg
PaclitaxelDrug
Paclitaxel 175 mg/m2
CarboplatinDrug
Carboplatin AUC 6

Study groups in NCT05654454
Study group	Role	What they receive
Bevacizumab with Paclitaxel and Carboplatin	Experimental	Patients 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. Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin
Avastin® with Paclitaxel and Carboplatin	Active comparator	Patients 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. Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 18 weeks from randomisation

Secondary outcomes (3)

Progression-free Survival (PFS)
Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.
Measured: At week 18 and 42 from randomisation
Overall Survival (OS)
Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
Measured: At week 18 and 42 from randomisation
Duration of response (DOR)
Duration of responce was defined as the time from responce to treatment till progression or death.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 2023Mar 2027

First posted16 Dec 2022
Study start31 May 2023
Primary completionDec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 620 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05654454
Sponsor's protocol ID: BEV-III/2022
Status last verified: Aug 2024
First submitted: 8 Dec 2022
Last updated: 16 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05654454
Acronym / sponsor ID: BEV-III/2022
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 620 participants (estimated)
Lead sponsor: Mabscale, LLCIndustry (pharma, biotech, devices)
Study start: 31 May 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 16 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Bevacizumab with Paclitaxel and Carboplatin	Experimental	Drug: Bevacizumab, Drug: Paclitaxel, Drug: CarboplatinPatients 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 comparator	Drug: Bevacizumab, Drug: Paclitaxel, Drug: CarboplatinPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BevacizumabBevacizumab 15 mg/kg	Drug	Avastin® with Paclitaxel and Carboplatin, Bevacizumab with Paclitaxel and Carboplatin
PaclitaxelPaclitaxel 175 mg/m2	Drug	Avastin® with Paclitaxel and Carboplatin, Bevacizumab with Paclitaxel and Carboplatin
CarboplatinCarboplatin AUC 6	Drug	Avastin® with Paclitaxel and Carboplatin, Bevacizumab with Paclitaxel and Carboplatin

Primary outcome

Objective Response Rate (ORR) at Week 18
Time frame: 18 weeks from randomisation
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).

3 secondary outcomes

Progression-free Survival (PFS)
Time frame: At week 18 and 42 from randomisation
Overall Survival (OS)
Time frame: At week 18 and 42 from randomisation
Duration of response (DOR)
Time frame: 48 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Alexander Generalov, MD contact

+74997149289

generalov.a@benerix.ru

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Mabscale, LLC at 28 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Generalov, MD (+74997149289, generalov.a@benerix.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) at Week 18 (time frame: 18 weeks from randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.