A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
NCT ID: NCT05654454
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
620 participants
INTERVENTIONAL
2023-05-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bevacizumab with Paclitaxel and Carboplatin
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.
Bevacizumab
Bevacizumab 15 mg/kg
Paclitaxel
Paclitaxel 175 mg/m2
Carboplatin
Carboplatin AUC 6
Avastin® with Paclitaxel and Carboplatin
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.
Bevacizumab
Bevacizumab 15 mg/kg
Paclitaxel
Paclitaxel 175 mg/m2
Carboplatin
Carboplatin AUC 6
Interventions
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Bevacizumab
Bevacizumab 15 mg/kg
Paclitaxel
Paclitaxel 175 mg/m2
Carboplatin
Carboplatin AUC 6
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mabscale, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Chapko
Role: primary
Ponomareva
Role: primary
Kudryavtsev
Role: primary
Safin
Role: primary
Smolin
Role: primary
Breder
Role: primary
Korelskaya
Role: primary
Matrosova
Role: primary
Kozlov
Role: primary
Zimina
Role: primary
Trefilova
Role: primary
Trefilova
Role: primary
Pen'kov
Role: primary
Vasiliev
Role: primary
Orlov
Role: primary
Belogortsev
Role: primary
Smagina
Role: primary
Poltoratsky
Role: primary
Schmelev
Role: primary
Kopp
Role: primary
Povaga
Role: primary
Haykin
Role: primary
Dergunov
Role: primary
Sakaeva
Role: primary
Mancirev
Role: primary
Kovalenko
Role: primary
Belonogov
Role: primary
Other Identifiers
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BEV-III/2022
Identifier Type: -
Identifier Source: org_study_id
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