A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
STELLA
A Randomized, Multicenter, Multinational, Double-Blind Study to Assess the Efficacy and Safety of MB02 (Bevacizumab Biosimilar Drug) Versus Avastin® in Combination With Carboplatin and Paclitaxel for the Treatment of Subjects With Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
627
18 countries
118
Brief Summary
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Feb 2018
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedResults Posted
Study results publicly available
March 26, 2021
CompletedApril 26, 2021
March 1, 2021
1.4 years
September 19, 2017
February 22, 2021
March 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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). Overall Response (OR) = CR + PR.
18 weeks from randomisation
Secondary Outcomes (4)
Progression-free Survival (PFS)
At Week 52 from randomisation
Overall Survival (OS)
At Week 52 from randomisation
Incidence of Treatment-emergent Adverse Events (TEAEs)
Week 1 to week 52
Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])
At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks
Study Arms (2)
MB02 (Bevacizumab Biosimilar Drug)
EXPERIMENTALMB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel
EU-approved Avastin®
ACTIVE COMPARATOREU-approved Avastin® + Carboplatin/Paclitaxel
Interventions
15 mg/kg IV every 3 weeks on Day 1
15 mg/kg IV every 3 weeks on Day 1
Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles
Eligibility Criteria
You may qualify if:
- Males and female subjects aged ≤ 18 years to ≤ 80 years.
- Signed informed consent must be obtained before initiation of any study-specific procedures or treatment as confirmation of the subject's awareness and willingness to comply with the study requirements.
You may not qualify if:
- Previous radiation therapy if completed \>4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if completed \>2 weeks of randomization.
- Subjects must have at least 1 unidimensional measurable lesion per RECIST version 1.1 (assessed locally).
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at Screening.
- Subjects must have adequate hepatic, renal and hematologic function defined as:
- Hepatic function: bilirubin level \<1.5 the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels\<2.5×ULN.
- Renal function: serum creatinine level \<1.5×ULN, calculated creatinine clearance (CrCl) \>50 mL/min (Cockcroft-Gault formula), urine protein to creatinine ratio \<1. Subjects with urine protein-to-creatinine ratio \>1 may be enrolled if they have \<1 g of protein in 24-hour urine collection.
- Hematological function: Absolute neutrophil count \>1.5×109 /L; platelets \>100×109 /L, hemoglobin (Hb) \>9 g/dL.
- Adequate coagulation parameters such as: INR ≤ 2.0 and aPTT ≤ 1.5 x ULN within 7 days prior to randomization for patients not receiving anticoagulation therapy.
- Eligible subjects must have a systolic blood pressure of ≤ 140 mm Hg and a diastolic blood pressure of ≤90 mm Hg at screening.
- Women of childbearing potential, and their partners, must agree to adhere to pregnancy prevention methods throughout the duration of the study (including the Follow-up visits, where applicable). Women of childbearing potential are defined as those who are not surgically sterile (did not underwent bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and not postmenopausal.
- Subjects and their partners must agree to use a highly effective method of contraception, to avoid women becoming pregnant throughout the course of the study. Medically acceptable forms of birth control can include the following, with approval of the treating physician:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence.
- \. Non fertile women can be included, that is, those who are physiologically incapable of becoming pregnant, because of:
- Hysterectomy.
- Bilateral oophorectomy (ovariectomy).
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
MedRadius
Maceió, Alagoas, Brazil
Instituto do Câncer do Ceará - ICC
Fortaleza, Ceará, Brazil
Centro Brasileiro de Radioterapia Oncologia e Mastologia
Goiânia, Goiás, Brazil
Hospital Erasto Gaertner - Paranaense de Combate ao Câncer
Curitiba, Paraná, Brazil
Instituto Nacional de Cancer- INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Centro de Pesquisa e Educação da Serra Gaúcha (CEPESG)
Caxias do Sul, Rio Grande do Sul, Brazil
IPCEM Universidade de Caxias Do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, Brazil
Instituto do Câncer - Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Pôrto Alegre, Rio Grande do Sul, Brazil
Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Hospital de Base de São José do Rio Preto
São José Do Rio Prêto, São Paulo, Brazil
Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, São Paulo, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, Brazil
Central Hospital Plovdiv
Plovdiv, Bulgaria
Acıbadem City Clinic Cancer Center UMHAT
Sofia, Bulgaria
Specialized Hospital for Active Treatment of Oncology Diseases Sofia District EOOD
Sofia, Bulgaria
Fundación Arturo López Pérez - Instituto Oncológico FALP
Santiago, Chile
Health & Care Spa
Santiago, Chile
Instituto Clinico Oncologico del Sur ICOS
Temuco, Chile
Oncocentro APYS
Viña del Mar, Chile
Cancer Center of Adjara Autonomous Republic
Batumi, Georgia
Acad. F . Todua medical center-research institute of clinical medicine
Tbilisi, Georgia
Consilium Medulla
Tbilisi, Georgia
Institute of Clinical Oncology
Tbilisi, Georgia
LTD Aversi Clinic
Tbilisi, Georgia
LTD Cancer Research Centre
Tbilisi, Georgia
Tbilisi State Medical Universitys First university Clinic
Tbilisi, Georgia
General Hospital of Athens "Ippokratio"
Athens, Greece
Sotiria General Hospital for Chest Diseases
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
Agioi Anargyroi General Oncological Hospital of Kifissia
Nea Kifissia, Greece
General Hospital of Thessaloniki "George Papanikolaou"
Thessaloniki, Greece
National Koranyi Institute of TB and Pulmonology
Budapest, Hungary
Országos Korányi Pulmonológiai Intézet (OKPI)
Budapest, Hungary
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
Deszk, Hungary
Veszprém Megyei Tüdőgyógyinzézet
Farkasgyepű, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Hungary
Zydus Hospital
Ahmedabad, India
Action Cancer Hospital
Delhi, India
Aadhar Health Institute
Hisar, India
NIMS - Nizam's Institute of Medical Sciences
Hyderabad, India
Ganadhipati Purushottam Shekhawati Hospital Research Centre
Jaipur, India
PVS Hospital Pvt Ltd
Kerola, India
Apollo Gleneagles Hospital
Kolkata, India
Netaji Subhas Chandra Bose Cancer Research Institute
Kolkata, India
Shatabdi Super Speciality Hospital
Nashik, India
Deenanath Mangeshkar Hospital & Research Center
Pune, India
Nirmal Hospital Pvt. Ltd.
Surat, India
Kiran Super Multispeciality Hospital
Sūrat, India
Shree Himalaya Cancer Hospital Research Institute
Vadodara, India
Queen's NRI Hospital Gurudwara Lane
Visakhapatnam, India
Notre Dame de Secours
Byblos, Lebanon
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Institut Perubatan dan Pergigian Termaju Universiti Sains Malaysia
Kepala Batas, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
National Cancer Institute
Putrajaya, Malaysia
Instituto Nacional de Cancerologia
Mexico City, Mexico
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Mexico
Sultan Qaboos University Hospital
Muscat, Oman
Baguio General Hospital & Medical Center
Baguio City, Philippines
Cebu Doctors University Hospital - CDUH
Cebu, Philippines
Perpetual Succour Hospital - PSH
Cebu, Philippines
St. Luke's Medical Center - Global City
City of Taguig, Philippines
De La Salle University Medical Center - DLSUMC
Dasmariñas, Philippines
Davao Doctors Hospital - DDH
Davao City, Philippines
Makati Medical Center
Makati City, Philippines
Philippine General Hospital - PGH
Manila, Philippines
The Medical City
Pasig, Philippines
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
Regional state budgetary Healthcare Institution "Belgorod oncology dispensary"
Belgorod, Russia
State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Kaluga Regional Clinical Oncology center
Kaluga, Russia
Republic Clinical Oncology Dispensary
Kazan', Russia
Kursk Republican Clinical Oncology Dispensary
Kursk, Russia
"VitaMed" LLC
Moscow, Russia
Moscow City Oncology Hospital No 62
Moscow, Russia
N. N. Blokhin Russian Cancer Research Center
Moscow, Russia
University Headache Clinic LLC
Moscow, Russia
GBUZ of SK Pyatigorsk Oncology Dispensary
Pyatigorsk, Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, Russia
City Clinical Oncology Dispensary
Saint Petersburg, Russia
GUZ "Leningrad Regional Clinical Hospital"
Saint Petersburg, Russia
State Budgetary healthcare Institution "Samara regional clinical oncology dispensary"
Samara, Russia
Federal budget Healthcare Institution "Volga District Medical Centre" under Federal Medical and Biological Agency
Veliky Novgorod, Russia
CHC Bezanijska Kosa
Belgrade, Serbia
Institute of Oncology and Radiology of Serbia (IORS)
Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinical center Nis (Clinic for pulmonary diseases)
Niš, Serbia
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Bangkok International Hospital And Wattanosod Hospital
Bangkok, Thailand
Chiang Mai University (CMU) - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Chiang Rai Prachanukroh Hospital
Chiang Rai, Thailand
Songklanagarind Hospital
Hat Yai, Thailand
Buddhachinaraj Hospital
Phitsanulok, Thailand
Istanbul Medeniyet University Medical Faculty
Istanbul, Turkey (Türkiye)
Suat Seren Chest Diseases Hospital
Izmir, Turkey (Türkiye)
Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
Cherkasy, Ukraine
Public Higher Education Insititution of Ukraine "Bukovinian State Medical University"
Chernivtsi, Ukraine
Clinical Oncology Dispensary
Dnipro, Ukraine
Multifield Clinical Hospital No.4
Dnipro, Ukraine
State Institution "Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine"
Kharkiv, Ukraine
State Institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine"
Kharkiv, Ukraine
Medical and Diagnostic Centre Private Enterprise of Private Manufacturing Company "ACINUS"
Kropyvnytskyi, Ukraine
Municipal Institution "Kryviy Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
Kryvyi Rih, Ukraine
National Cancer Institute
Kyiv, Ukraine
National Institute of Cancer
Kyiv, Ukraine
Healthcare facility "Volyn regional Oncological Dispensary"
Lutsk, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center
Lviv, Ukraine
Odessa Regional Clinical Oncology Dispensary
Odesa, Ukraine
Uzhgorod National University
Uzhhorod, Ukraine
Vinnytsia Regional Clinical Oncology Dispensary
Vinnytsia, Ukraine
Communal Institution "Zaporizhzhya Regional Clinical Oncological Dispensary" of Zaporizhzhya regional council
Zaporizhzhya, Ukraine
Related Publications (1)
Trukhin D, Poddubskaya E, Andric Z, Makharadze T, Bellala RS, Charoentum C, Yanez Ruiz EP, Fulop A, Hyder Ali IA, Syrigos K, Katgi N, Lopez Chuken YA, Rumyana I, Reyes-Igama J, Costamilan RC, Del Campo Garcia A, Florez A, Paravisini A, Millan S; STELLA Investigators. Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA). BioDrugs. 2021 Jul;35(4):429-444. doi: 10.1007/s40259-021-00483-w. Epub 2021 Apr 29.
PMID: 33914256DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susana Millan
- Organization
- mAbxience Research SL
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 28, 2017
Study Start
February 6, 2018
Primary Completion
July 3, 2019
Study Completion
February 27, 2020
Last Updated
April 26, 2021
Results First Posted
March 26, 2021
Record last verified: 2021-03