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Non-small Cell Lung CancerPhase 3STELLANCT03296163

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin® and Carboplatin in people with Non-small Cell Lung Cancer, run by mAbxience Research S.L. at 118 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin® and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
627 participants
Where
118 sitesin 18 countries
Study dates
6 Feb 2018to 27 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subjects should have newly diagnosed or recurrent Stage IIIB/IV (defined by seventh edition of the Tumor, Node and Metastasis (TNM) classification for Lung Cancer, 2010) non-squamous NSCLC not amenable to curative intent surgery, and not have received any systemic therapy for advanced disease (exclusion criteria 3 and 4). For subjects with recurrent disease, at least 6 months must have elapsed before randomization from previous adjuvant treatment.
  • 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.
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  • 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.
  • 10. Non fertile women can be included, that is, those who are physiologically incapable of becoming pregnant, because of:
  • Hysterectomy.
  • Bilateral oophorectomy (ovariectomy).
  • Bilateral tubal ligation or,
  • Postmenopausal women defined as:
  • Subjects not using hormone replacement therapy (HRT) and have experienced total cessation of menses for ≥ 1 year and be greater than 45 years of age, OR, in questionable cases, have a follicle stimulating hormone >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L).
  • Subjects must discontinue HRT before study enrolment because of the potential for inhibition of cytochrome enzymes that metabolize estrogens and progestins. For most forms of HRT, at least 2 to 4 weeks must elapse between the cessation of HRT and determination of menopausal status; the length of this interval depends on the type and dosage of HRT.
  • If a female subject is determined not to be postmenopausal, that subject must use adequate contraception, as defined immediately above (inclusion 8).

Who cannot join

  • Inability to comply with protocol procedures.
  • Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives of investigational agent before randomization, whichever is longer.
  • Subjects previously treated with monoclonal antibodies or small molecule inhibitors against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.
  • Subjects who have received previous chemotherapy, immunotherapy, targeted therapy, or biological therapy for their lung cancer. Note: Adjuvant and neo- adjuvant therapy are permitted (see: inclusion criterion 3).
  • Subjects who have known central nervous system disease, with the exception of subjects with treated brain metastases who have completed treatment (radiation, surgery or stereotactic surgery) and have not received steroids for at least 4 weeks before randomization. Subjects with central nervous system metastases treated by neurosurgical resection or brain biopsy performed within 8 weeks before randomization will be excluded. Subjects with known or history of brain metastases must undergo brain imaging during screening.
  • Current or recent (within 10 days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other nonsteroidal anti-inflammatory drugs with antiplatelet activity or treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®), or cilostazol (Pletal®).
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  • Current or recent (within 5 days) use of therapeutic anticoagulation or use of thrombolytic agent. Prophylactic use of low molecular weight heparin is allowed.
  • Subjects with an INR >2, unless receiving active anticoagulation treatment, will be excluded.
  • Subjects who have a diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung. Mixed tumors should be categorized according to the predominant histology. If small cell elements are present, the subject will be excluded.
  • Subjects with known tumors that harbor activating epidermal growth factor receptor and anaplastic lymphoma receptor tyrosine kinase (assessed locally).
  • Subjects who have a history of hypersensitivity to the active substance (bevacizumab, carboplatin, and/or paclitaxel) or any of the excipients (such as trehalose dehydrate, sodium phosphate, or polysorbate 20).
  • Subjects with known active viral infection, including but not limited to: hepatitis B, hepatitis C, or HIV.
  • Subjects who are pregnant or breastfeeding. Women of child-bearing potential must have a negative pregnancy test at Screening.
  • Subjects with previous major surgery, open biopsy, open pleurodesis, or significant traumatic injury within 4 weeks before randomization or those anticipated to require major surgery during the study.
  • Subjects who have had a core biopsy taken or have had another minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 1 week of randomization.
  • Subjects with a history of abdominal fistula, GI perforation, intra-abdominal abscess within 6 months of randomization.
  • Subjects with a nonhealing wound, active ulcer, or untreated bone fracture.
  • Subjects with previous history of hypertensive crisis or hypertensive encephalopathy.
  • Subjects with New York Heart Association Grade II or greater congestive heart failure, or angina, myocardial infarction within 6 months before randomization; symptomatic arrhythmia or serious cardiac arrhythmia requiring medication; abnormal left ventricular ejection fraction < 50% assessed by ultrasound or multigated acquisition scan.
  • Subjects with a previous malignancy within 3 years of randomization (other than superficial basal cell and superficial squamous (skin) cell carcinoma, or carcinoma in situ of the uterine cervix, bladder, or prostate).
  • Subjects with history of a significant vascular event within 6 months before randomization (including, but not limited to myocardial infarction and stroke or transient ischemic attack).
  • Subjects with known bleeding diathesis or significant coagulopathy defined as a bleeding event grade ≥ 2 within 3 months before randomization.
  • Subjects with history of grade ≥2 hemoptysis within 6 months before randomization (≥0.5 teaspoons of bright red blood per event).
  • Subjects with a tumor(s) invading or compressing major blood vessels.

Trial locations and contacts

118 sites in 18 countries.

118 sites in 18 countries

Russia16 sites

  • SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk

  • Regional state budgetary Healthcare Institution "Belgorod oncology dispensary"

    Belgorod

  • State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary

    Ivanovo

  • Kaluga Regional Clinical Oncology center

    Kaluga

  • Republic Clinical Oncology Dispensary

    Kazan'

  • Kursk Republican Clinical Oncology Dispensary

    Kursk

  • "VitaMed" LLC

    Moscow

  • Moscow City Oncology Hospital No 62

    Moscow

  • N. N. Blokhin Russian Cancer Research Center

    Moscow

  • University Headache Clinic LLC

    Moscow

  • GBUZ of SK Pyatigorsk Oncology Dispensary

    Pyatigorsk

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan

  • City Clinical Oncology Dispensary

    Saint Petersburg

  • GUZ "Leningrad Regional Clinical Hospital"

    Saint Petersburg

  • State Budgetary healthcare Institution "Samara regional clinical oncology dispensary"

    Samara

  • Federal budget Healthcare Institution "Volga District Medical Centre" under Federal Medical and Biological Agency

    Velikiy Novgorod

Other trials in Russia

Ukraine16 sites

  • Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council

    Cherkasy

  • Public Higher Education Insititution of Ukraine "Bukovinian State Medical University"

    Chernivtsi

  • Clinical Oncology Dispensary

    Dnipro

  • Multifield Clinical Hospital No.4

    Dnipro

  • State Institution "Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine"

    Kharkiv

  • State Institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine"

    Kharkiv

  • Medical and Diagnostic Centre Private Enterprise of Private Manufacturing Company "ACINUS"

    Kropyvnytskyi

  • Municipal Institution "Kryviy Rih Oncology Dispensary" of Dnipropetrovsk Regional Council

    Kryvyi Rih

  • National Cancer Institute

    Kyiv

  • National Institute of Cancer

    Kyiv

  • Healthcare facility "Volyn regional Oncological Dispensary"

    Lutsk

  • Lviv State Oncology Regional Treatment and Diagnostic Center

    Lviv

  • Odessa Regional Clinical Oncology Dispensary

    Odesa

  • Uzhgorod National University

    Uzhhorod

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnytsia

  • Communal Institution "Zaporizhzhya Regional Clinical Oncological Dispensary" of Zaporizhzhya regional council

    Zaporizhzhya

Other trials in Ukraine

Brazil15 sites

  • Hospital de Câncer de Barretos

    Barretos, São Paulo

  • Centro de Pesquisa e Educação da Serra Gaúcha (CEPESG)

    Caxias do Sul, Rio Grande do Sul

  • IPCEM Universidade de Caxias Do Sul

    Caxias do Sul, Rio Grande do Sul

  • Hospital Erasto Gaertner - Paranaense de Combate ao Câncer

    Curitiba, Paraná

  • Instituto do Câncer do Ceará - ICC

    Fortaleza, Ceará

  • Centro Brasileiro de Radioterapia Oncologia e Mastologia

    Goiânia, Goiás

  • Hospital de Caridade de Ijuí

    Ijuí, Rio Grande do Sul

  • MedRadius

    Maceió, Alagoas

  • Instituto do Câncer - Hospital São Vicente de Paulo

    Passo Fundo, Rio Grande do Sul

  • Hospital São Lucas da PUCRS

    Pôrto Alegre, Rio Grande do Sul

  • Instituto Nacional de Cancer- INCA

    Rio de Janeiro, Rio de Janeiro

  • Hospital de Base de São José do Rio Preto

    São José Do Rio Prêto, São Paulo

  • Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC

    São Paulo, São Paulo

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, São Paulo

  • Hospital Santa Marcelina

    São Paulo

Other trials in Brazil

India14 sites

  • Zydus Hospital

    Ahmedabad

  • Action Cancer Hospital

    Delhi

  • Aadhar Health Institute

    Hisar

  • NIMS - Nizam's Institute of Medical Sciences

    Hyderabad

  • Ganadhipati Purushottam Shekhawati Hospital Research Centre

    Jaipur

  • PVS Hospital Pvt Ltd

    Kerola

  • Apollo Gleneagles Hospital

    Kolkata

  • Netaji Subhas Chandra Bose Cancer Research Institute

    Kolkata

  • Shatabdi Super Speciality Hospital

    Nashik

  • Deenanath Mangeshkar Hospital & Research Center

    Pune

  • Nirmal Hospital Pvt. Ltd.

    Surat

  • Kiran Super Multispeciality Hospital

    Sūrat

  • Shree Himalaya Cancer Hospital Research Institute

    Vadodara

  • Queen's NRI Hospital Gurudwara Lane

    Visakhapatnam

Other trials in India

Philippines9 sites

  • Baguio General Hospital & Medical Center

    Baguio City

  • Cebu Doctors University Hospital - CDUH

    Cebu

  • Perpetual Succour Hospital - PSH

    Cebu

  • St. Luke's Medical Center - Global City

    City of Taguig

  • De La Salle University Medical Center - DLSUMC

    Dasmariñas

  • Davao Doctors Hospital - DDH

    Davao City

  • Makati Medical Center

    Makati City

  • Philippine General Hospital - PGH

    Manila

  • The Medical City

    Pasig

Other trials in Philippines

Georgia7 sites

  • Cancer Center of Adjara Autonomous Republic

    Batumi

  • Acad. F . Todua medical center-research institute of clinical medicine

    Tbilisi

  • Consilium Medulla

    Tbilisi

  • Institute of Clinical Oncology

    Tbilisi

  • LTD Aversi Clinic

    Tbilisi

  • LTD Cancer Research Centre

    Tbilisi

  • Tbilisi State Medical Universitys First university Clinic

    Tbilisi

Other trials in Georgia

Malaysia7 sites

  • Hospital Pulau Pinang

    George Town, Pulau Pinang

  • Institut Perubatan dan Pergigian Termaju Universiti Sains Malaysia

    Kepala Batas

  • Hospital Kuala Lumpur

    Kuala Lumpur

  • Pusat Perubatan Universiti Kebangsaan Malaysia

    Kuala Lumpur

  • University Malaya Medical Centre

    Kuala Lumpur

  • Hospital Umum Sarawak

    Kuching

  • National Cancer Institute

    Putrajaya

Other trials in Malaysia

Greece5 sites

  • General Hospital of Athens "Ippokratio"

    Athens

  • Sotiria General Hospital for Chest Diseases

    Athens

  • University General Hospital of Larissa

    Larissa

  • Agioi Anargyroi General Oncological Hospital of Kifissia

    Nea Kifissia

  • General Hospital of Thessaloniki "George Papanikolaou"

    Thessaloniki

Other trials in Greece

Hungary5 sites

  • National Koranyi Institute of TB and Pulmonology

    Budapest

  • Országos Korányi Pulmonológiai Intézet (OKPI)

    Budapest

  • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza

    Deszk

  • Veszprém Megyei Tüdőgyógyinzézet

    Farkasgyepű

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc

Other trials in Hungary

Serbia5 sites

  • CHC Bezanijska Kosa

    Belgrade

  • Institute of Oncology and Radiology of Serbia (IORS)

    Belgrade

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz

  • Clinical Center Kragujevac

    Kragujevac

  • Clinical center Nis (Clinic for pulmonary diseases)

    Niš

Other trials in Serbia

Thailand5 sites

  • Bangkok International Hospital And Wattanosod Hospital

    Bangkok

  • Chiang Mai University (CMU) - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital

    Chiang Mai

  • Chiang Rai Prachanukroh Hospital

    Chiang Rai

  • Songklanagarind Hospital

    Hat Yai

  • Buddhachinaraj Hospital

    Phitsanulok

Other trials in Thailand

Chile4 sites

  • Fundación Arturo López Pérez - Instituto Oncológico FALP

    Santiago

  • Health & Care Spa

    Santiago

  • Instituto Clinico Oncologico del Sur ICOS

    Temuco

  • Oncocentro APYS

    Viña del Mar

Other trials in Chile

Bulgaria3 sites

  • Central Hospital Plovdiv

    Plovdiv

  • Acıbadem City Clinic Cancer Center UMHAT

    Sofia

  • Specialized Hospital for Active Treatment of Oncology Diseases Sofia District EOOD

    Sofia

Other trials in Bulgaria

Mexico2 sites

  • Instituto Nacional de Cancerologia

    Mexico City

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey

Other trials in Mexico

Turkey (Türkiye)2 sites

  • Istanbul Medeniyet University Medical Faculty

    Istanbul

  • Suat Seren Chest Diseases Hospital

    Izmir

Other trials in Turkey (Türkiye)

Lebanon1 site

  • Notre Dame de Secours

    Byblos

Other trials in Lebanon

Oman1 site

  • Sultan Qaboos University Hospital

    Muscat

Other trials in Oman

Spain1 site

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid

Other trials in Spain

About this study

Official title: 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)

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

Read the detailed description

Efficacy parameters, safety profiles and immunogenicity will be compared between MB02 (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®

Being tested
MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin, Paclitaxel
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.

  • MB02 (Bevacizumab Biosimilar Drug)Drug

    Also called Bevacizumab

    15 mg/kg IV every 3 weeks on Day 1

  • EU-approved Avastin®Drug

    Also called Bevacizumab

    15 mg/kg IV every 3 weeks on Day 1

  • CarboplatinDrug

    Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles

Study groups in NCT03296163
Study groupRoleWhat they receive
MB02 (Bevacizumab Biosimilar Drug)ExperimentalMB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel
Receives: Drug: MB02 (Bevacizumab Biosimilar Drug); Drug: Carboplatin; Drug: Paclitaxel
EU-approved Avastin®Active comparatorEU-approved Avastin® + Carboplatin/Paclitaxel
Receives: Drug: EU-approved Avastin®; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  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.

    Measured: 18 weeks from randomisation

Secondary outcomes (4)

  1. 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 52 from randomisation

  2. Overall Survival (OS)

    Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.

    Measured: At Week 52 from randomisation

  3. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);

    Measured: Week 1 to week 52

  4. Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])

    Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.

    Measured: 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

Timeline

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

  1. First posted28 Sep 2017
  2. Study start6 Feb 2018
  3. Primary completion3 Jul 2019
  4. Study completion27 Feb 2020

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
627 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296163
Sponsor's protocol ID
MB02-C-02-17
Acronym
STELLA
Status last verified
Mar 2021
First submitted
19 Sep 2017
Last updated
26 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33914256

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin® and Carboplatin in people with Non-small Cell Lung Cancer, run by mAbxience Research S.L. at 118 sites in 18 countries.

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 23 inclusion and 24 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Russia, Ukraine, Brazil, India, Philippines and 13 more countries. 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?

Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT03296163, which also lists 1 linked publication.

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 26 Apr 2021.

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STELLA Clinical Trial NCT03296163 | AzTrials