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Lung CancerPhase 3NCT02754882

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

A Phase 3 study testing Bevacizumab, SB8 and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer, run by Samsung Bioepis Co., Ltd. at 105 sites in 13 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 study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-small Cell Lung Cancer
What is being tested?
Bevacizumab, SB8 and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
763 participants
Where
105 sitesin 13 countries
Study dates
5 Jul 2016to 9 Oct 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years
  • ECOG performance status of 0-1
  • Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
  • At least one measurable lesion according to RECIST v1.1.
  • Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Who cannot join

  • Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  • Sensitizing EGFR mutations or ALK rearrangements
  • Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  • History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

Trial locations and contacts

105 sites in 13 countries.

105 sites in 13 countries

Russia21 sites

  • State Budgetary Institution of Arkhangelsk Oblast "Arkhangelsk Region Clinical Oncology Center

    Arkhangelsk, 163045

  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"

    Chelyabinsk, 454087

  • State Autonomous Healthcare Institution "Republican Clinical Oncology Center of Ministry of Healthcare of Tatarstan Republic"

    Kazan', 420029

  • State Budgetary Healthcare Institution "Regional Clinical Hospital #1 n.a. professor S.V. Ochapovsky" of Ministry of Healthcare of Krasnodar Region

    Krasnodar, 350086

  • Federal State Budgetary Scientific Institution " N.N. Blokhin Russian Cancer Research Center" of the Ministry of Health of the Russian Federation

    Moscow, 115478

  • State Autonomous Healthcare Institution of Moscow "Moscow City Oncology Hospital # 62 of Healthcare Department of Moscow"

    Moscow, 143423

  • State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"

    Murmansk, 183047

  • State Budgetary Healthcare Institution of Nizhny Novgorod oblast "Nizhny Novgorod Region Oncology Center"

    Nizhny Novgorod, 603081

  • State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncology Center"

    Novosibirsk, 630108

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

    Omsk, 644013

  • Federal Budgetary Healthcare Insittution "Saint-Petersburg Clinical Hospital of RAS"

    Saint Petersburg, 194017

  • State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital

    Saint Petersburg, 194291

  • Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Healthcare of the Russian Federation./ Scientific Research Institute of Pulmonology

    Saint Petersburg, 197022

  • Federal State Budgetary Institution " Scientific Research Institute of Oncology n.a. N.N. Petrov" of Ministry of Healthcare of the Russian Federation

    Saint Petersburg, 197758

  • Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Center"

    Saint Petersburg, 198255

  • Private foundation of Educational establishment of Higher Education Medical University "REAVIZ"

    Samara, 443011

  • State Budgetary Healthcare Institution " Oncology Center #2" of Krasnodar Region Ministry of Healthcare

    Sochi, 354057

  • State Budgetary Healthcare Institution Republican Clinical Oncology Center of Ministry of Healthcare of the Republic of Bashkortostan

    Ufa, 450054

  • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"

    Volzhskiy, 404130

  • State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

    Yaroslavl, 150040

  • State Budgetary Healthcare Institution of Sverdlovskaya Oblast "Sverdlovsk Regional Oncology Center"

    Yekaterinburg, 620036

Other trials in Russia

Romania11 sites

  • Med Life

    Bucharest, 031784

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Medisprof

    Cluj-Napoca, 400058

  • Spitalul Clinic Judetean de Urgenta Constanta

    Constanța, 900591

  • Centrul de Oncologie Sf. Nectarie

    Craiova, 200347

  • Oncolab

    Craiova, 200385

  • Radiotherapy Center CJ radioterapie si chimioterapie adulti

    Floreşti, 407280

  • Centrul de Oncologie Euroclinic

    Iași, 700106

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Pelican Impex

    Oradea, 410469

  • Oncocenter Oncologie Clinica

    Timișoara, 300210

Other trials in Romania

South Korea10 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Gyeongsang National University Hospital

    Jinju, 52727

  • CHA Bundang Medical Center, CHA University

    Seongnam, 13496

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 135-710

  • Catholic University of Korea, St. Vincent's Hospital

    Suwon, 442-723

  • Yonsei Universtiy, Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Spain9 sites

  • C.H. Provincial de Castellón

    Castellon, 12002

  • H.U. Severo Ochoa

    Leganés, 28911

  • H.G.U. G. Marañón

    Madrid, 28007

  • H.U. F. Jiménez Díaz

    Madrid, 28040

  • C.H. de Orense

    Ourense, 32005

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • H.U. Sant Joan de Reus

    Reus, 43204

  • C.H.U. de Canarias

    Santa Cruz de Tenerife, 38320

  • H.U.N. Sra. Valme

    Seville, 41014

Other trials in Spain

Georgia8 sites

  • JSC Maritime Hospital

    Batumi, 6010

  • JSC Saint Nikolozi Surgery Center

    Kutaisi, 4600

  • LTD Research Institute of Clinical Medicine

    Tbilisi, 0112

  • ICO-Institute of Clinical Oncology

    Tbilisi, 0159

  • New Vision University Hospital

    Tbilisi, 0159

  • LTD MediClubGeorgia

    Tbilisi, 0160

  • Institute for Personalized Medicine LTD

    Tbilisi, 0186

  • LTD Chemotherapy and Immunotherapy Clinic Medulla

    Tbilisi, 0186

Other trials in Georgia

Germany8 sites

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, 33611

  • Universitätsklinikum Bonn

    Bonn, 53127

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • University Hospital Homburg

    Homburg, 66421

  • Klinikum Kassel

    Kassel, 34125

  • Universitätsklinikum Leipzig [Pneumologie]

    Leipzig, 04103

  • Klinik Löwenstein

    Löwenstein, 74245

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063

Other trials in Germany

Ukraine8 sites

  • Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo

    Chernivtsi, 58013

  • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

    Dnipropetrovsk, 49102

  • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

    Kharkiv, 61070

  • Khmelnytskyi oblasnyi onkolohichnyi dyspanser

    Khmelnytskyi, 29009

  • Odeskyi oblasnyi onkolohichnyi dyspanser

    Odesa, 65055

  • OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"

    Sumy, 40022

  • Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser

    Vinnytsia, 21029

  • Zaporozhye Regional Clinical Oncology Center

    Zaporizhzhya, 69040

Other trials in Ukraine

Hungary7 sites

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1121

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1521

  • Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel

    Budapest, H-1529

  • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

    Deszk, 6772

  • Veszprem Megyei Onkormanyzat Tudogyogyintezete

    Farkasgyepű, 8582

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

    Szolnok, 5004

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, H-9700

Other trials in Hungary

Belarus6 sites

  • Brest Regional Oncology Dispensary

    Brest, 224027

  • Grodno Regional Clinical Hospital

    Grodno, 230017

  • N. N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology

    Lesnoy, 223040

  • Minsk city Clinical Oncological Dispensary

    Minsk, 220013

  • Mogilev Regional Oncological Dispensary

    Mogilev, 212018

  • Vitebsk Regional Clinical Oncological Dispensary

    Vitebsk, 210603

Other trials in Belarus

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-Da Hospital

    Kaohsiung City, 824

  • China Medical University Hospital

    Taichung, 40447

  • Chang Gung Medical Foundation, Linkou

    Taoyuan, 33305

Other trials in Taiwan

Thailand5 sites

  • Siriraj Hospital

    Bangkok, 10700

  • ChiangMai Univerisity

    Chiang Mai, 50200

  • Chiangrai Prachanukroh Hospital

    Chiang Rai, 57000

  • Prince of Songkla University

    Hat Yai, 90110

  • Udonthani Cancer Hospital

    Udon Thani, 41330

Other trials in Thailand

Serbia4 sites

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11070

  • Clinical Center Kragujevac, Clinic for Pulmology

    Kragujevac, 34000

  • Clinical Centre Nis

    Niš, 18000

Other trials in Serbia

Poland3 sites

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • MED-POLONIA Sp.z o.o.

    Poznan, 60-693

Other trials in Poland

About this study

Official title: A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

Read the detailed description

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.

Keywords
NSCLC, bevacizumab, avastin
Medical subject headings
Lung Neoplasms, 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

    Also called Avastin®

    Avastin® 15 mg/kg IV every 3 weeks on Day 1

  • SB8Drug

    Also called SB8 (A proposed bevacizumab biosimilar)

    SB8 15 mg/kg IV every 3 weeks on Day 1

  • CarboplatinDrug

    Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Study groups in NCT02754882
Study groupRoleWhat they receive
Bevacizumab (Avastin)Active comparatorAvastin® + Carboplatin/Paclitaxel
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel
SB8 (A proposed bevacizumab biosimilar)ExperimentalSB8 + Carboplatin/Paclitaxel
Receives: Drug: SB8; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  1. Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks

    The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks.

    CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: 24 weeks from randomisation

Secondary outcomes (8)

  1. Progression Free Survival

    PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease [PD]) or death regardless of the cause of death.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject

  2. Overall Survival

    OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death.

    Subjects who were alive at the time of analysis were censored at the date of last known alive.

    Measured: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject

  3. Duration of Response (DoR)

    DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject

    Measured: from documented tumour response until disease progression up to 12 months from randomisation of the last subject

  4. Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03

    After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.

    Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE

    Measured: AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation.

  5. Pharmacokinetics: Trough Level [Ctrough]

    Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7)

    Measured: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)

  6. Pharmacokinetics: Maximum Plasma Concentration [Cmax]

    Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7)

    Measured: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)

  7. Immunogenicity Assessments (Anti-drug Antibodies)

    Incidence of anti-drug (bevacizumab) antibodies (ADA)

    The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below:

    • 'Positive' for a subject with treatment-induced or treatment-boosted ADA, where treatment-induced ADA indicated at least one positive result after pre-dose of Cycle 1 for subjects with negative ADA at pre-dose of Cycle 1, and treatment-boosted ADA indicated at least one positive result with higher titre level compared to pre-dose of Cycle 1 after pre-dose of Cycle 1 for subjects with positive ADA at pre-dose of Cycle 1.
    • 'Negative' for a subject without positive ADA until Cycle 7 and EOT.
    • 'Inconclusive' for a subject with positive ADA at Cycle 1 and without positive result with higher titre level observed after pre-dose of Cycle 1 up to Cycle 7 and EOT.

    Measured: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.

  8. Immunogenicity Assessments (Neutralizing Antibodies)

    Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF.

    The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary.

    Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies).

    Measured: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.

Timeline

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

  1. First posted28 Apr 2016 (estimated)
  2. Study start5 Jul 2016
  3. Primary completion24 Jan 2018
  4. Study completion9 Oct 2018

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
763 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754882
Sponsor's protocol ID
SB8-G31-NSCLC
Status last verified
Dec 2024
First submitted
24 Mar 2016
Last updated
16 Dec 2024
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, SB8 and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer, run by Samsung Bioepis Co., Ltd. at 105 sites in 13 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 5 inclusion and 4 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Russia, Romania, South Korea, Spain, Georgia and 8 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 16 Dec 2024). 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?

Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks (time frame: 24 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 NCT02754882.

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 Dec 2024.

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