Back to resultsA Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Bevacizumab
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
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
Sites / Locations
- Arkhangelsk Clinical Oncological DispensaryRecruiting
- State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
- Kaluga Regional Medical Oncology DispensaryRecruiting
- Regional clinical oncological dispensary n.a.SigalRecruiting
- Hadassah Medical MoscowRecruiting
- National Medical Oncology Research Center n.a. N.N. Blokhina
- Murmansk Regional Clinical Hospital
- Novosibirsk oncologic dispensaryRecruiting
- Omsk clinical oncologic dispensaryRecruiting
- Clinical Hospital RZD-MedicineRecruiting
- Euro CityclinicRecruiting
- Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)Recruiting
- Leningrad regional clinical hospitalRecruiting
- National Medical Research Center of Oncology N.A. N.N. PetrovRecruiting
- Northwestern Center for Evidence-Based MedicineRecruiting
- Medical University "Reaviz"Recruiting
- Smolensk oncologic dispensary
- Volgograd Regional Clinical Oncology DispensaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab with Paclitaxel and Carboplatin
Avastin® with Paclitaxel and Carboplatin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Overall Survival (OS)
Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
Duration of response (DOR)
Duration of responce was defined as the time from responce to treatment till progression or death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05654454
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabscale, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
620 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab with Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Avastin® with Paclitaxel and Carboplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 15 mg/kg
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m2
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 6
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) at Week 18
Description
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).
Time Frame
18 weeks from randomisation
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
At week 18 and 42 from randomisation
Title
Overall Survival (OS)
Description
Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
Time Frame
At week 18 and 42 from randomisation
Title
Duration of response (DOR)
Description
Duration of responce was defined as the time from responce to treatment till progression or death.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander BORISOV, MD
Phone
+74997149289
Email
borisov.a@benerix.ru
Facility Information:
Facility Name
Arkhangelsk Clinical Oncological Dispensary
City
Arkhangel'sk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chapko
Facility Name
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
City
Ivanovo
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ponomareva
Facility Name
Kaluga Regional Medical Oncology Dispensary
City
Kaluga
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kudryavtsev
Facility Name
Regional clinical oncological dispensary n.a.Sigal
City
Kazan'
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safin
Facility Name
Hadassah Medical Moscow
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kudryavtseva
Facility Name
National Medical Oncology Research Center n.a. N.N. Blokhina
City
Moscow
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laktionov
Facility Name
Murmansk Regional Clinical Hospital
City
Murmansk
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Korelskaya
Facility Name
Novosibirsk oncologic dispensary
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kozlov
Facility Name
Omsk clinical oncologic dispensary
City
Omsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zimina
Facility Name
Clinical Hospital RZD-Medicine
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasiliev
Facility Name
Euro Cityclinic
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orlov
Facility Name
Leningrad regional clinical hospital (prev.Oncological dispensary n.a.Roman)
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osipov
Facility Name
Leningrad regional clinical hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smagina
Facility Name
National Medical Research Center of Oncology N.A. N.N. Petrov
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poltoratsky
Facility Name
Northwestern Center for Evidence-Based Medicine
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schmelev
Facility Name
Medical University "Reaviz"
City
Samara
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kopp
Facility Name
Smolensk oncologic dispensary
City
Smolensk
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Povaga
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kovalenko
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Bevacizumab, Paclitaxel, Carboplatin Compared to Avastin® in Non-Small Cell Lung Cancer
We'll reach out to this number within 24 hrs