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

NCT ID: NCT02754882

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

763 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2018-10-09

Brief Summary

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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).

Detailed Description

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

Conditions

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Lung Cancer Non-small Cell Lung Cancer

Keywords

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NSCLC bevacizumab avastin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bevacizumab (Avastin)

Avastin® + Carboplatin/Paclitaxel

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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

SB8 (A proposed bevacizumab biosimilar)

SB8 + Carboplatin/Paclitaxel

Group Type EXPERIMENTAL

SB8

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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

Interventions

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Bevacizumab

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

Intervention Type DRUG

SB8

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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Avastin® SB8 (A proposed bevacizumab biosimilar) Taxol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Reck, M.D.

Role: PRINCIPAL_INVESTIGATOR

LungenClinic Grosshansdorf, Germany

Locations

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Brest Regional Oncology Dispensary

Brest, , Belarus

Site Status

Grodno Regional Clinical Hospital

Grodno, , Belarus

Site Status

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

Lesnoy, , Belarus

Site Status

Minsk city Clinical Oncological Dispensary

Minsk, , Belarus

Site Status

Mogilev Regional Oncological Dispensary

Mogilev, , Belarus

Site Status

Vitebsk Regional Clinical Oncological Dispensary

Vitebsk, , Belarus

Site Status

JSC Maritime Hospital

Batumi, , Georgia

Site Status

JSC Saint Nikolozi Surgery Center

Kutaisi, , Georgia

Site Status

LTD Research Institute of Clinical Medicine

Tbilisi, , Georgia

Site Status

ICO-Institute of Clinical Oncology

Tbilisi, , Georgia

Site Status

New Vision University Hospital

Tbilisi, , Georgia

Site Status

LTD MediClubGeorgia

Tbilisi, , Georgia

Site Status

Institute for Personalized Medicine LTD

Tbilisi, , Georgia

Site Status

LTD Chemotherapy and Immunotherapy Clinic Medulla

Tbilisi, , Georgia

Site Status

Evangelisches Krankenhaus Bielefeld

Bielefeld, , Germany

Site Status

Universitätsklinikum Bonn

Bonn, , Germany

Site Status

LungenClinic Grosshansdorf GmbH

Großhansdorf, , Germany

Site Status

University Hospital Homburg

Homburg, , Germany

Site Status

Klinikum Kassel

Kassel, , Germany

Site Status

Universitätsklinikum Leipzig [Pneumologie]

Leipzig, , Germany

Site Status

Klinik Löwenstein

Löwenstein, , Germany

Site Status

Klinikum der Stadt Ludwigshafen

Ludwigshafen, , Germany

Site Status

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, , Hungary

Site Status

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, , Hungary

Site Status

Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel

Budapest, , Hungary

Site Status

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

Deszk, , Hungary

Site Status

Veszprem Megyei Onkormanyzat Tudogyogyintezete

Farkasgyepű, , Hungary

Site Status

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

Szolnok, , Hungary

Site Status

Markusovszky Egyetemi Oktatókórház

Szombathely, , Hungary

Site Status

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

Olsztyn, , Poland

Site Status

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Site Status

MED-POLONIA Sp.z o.o.

Poznan, , Poland

Site Status

Med Life

Bucharest, , Romania

Site Status

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Site Status

Medisprof

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta Constanta

Constanța, , Romania

Site Status

Centrul de Oncologie Sf. Nectarie

Craiova, , Romania

Site Status

Oncolab

Craiova, , Romania

Site Status

Radiotherapy Center CJ radioterapie si chimioterapie adulti

Floreşti, , Romania

Site Status

Centrul de Oncologie Euroclinic

Iași, , Romania

Site Status

Institutul Regional de Oncologie Iasi

Iași, , Romania

Site Status

Pelican Impex

Oradea, , Romania

Site Status

Oncocenter Oncologie Clinica

Timișoara, , Romania

Site Status

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

Arkhangelsk, , Russia

Site Status

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"

Chelyabinsk, , Russia

Site Status

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

Kazan', , Russia

Site Status

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

Krasnodar, , Russia

Site Status

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

Moscow, , Russia

Site Status

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

Moscow, , Russia

Site Status

State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"

Murmansk, , Russia

Site Status

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

Nizhny Novgorod, , Russia

Site Status

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

Novosibirsk, , Russia

Site Status

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

Omsk, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital

Saint Petersburg, , Russia

Site Status

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, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

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

Samara, , Russia

Site Status

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

Sochi, , Russia

Site Status

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

Ufa, , Russia

Site Status

State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"

Volzhskiy, , Russia

Site Status

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

Yaroslavl, , Russia

Site Status

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

Yekaterinburg, , Russia

Site Status

Military Medical Academy

Belgrade, , Serbia

Site Status

Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

Site Status

Clinical Center Kragujevac, Clinic for Pulmology

Kragujevac, , Serbia

Site Status

Clinical Centre Nis

Niš, , Serbia

Site Status

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

CHA Bundang Medical Center, CHA University

Seongnam, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Catholic University of Korea, St. Vincent's Hospital

Suwon, , South Korea

Site Status

Yonsei Universtiy, Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

C.H. Provincial de Castellón

Castellon, , Spain

Site Status

H.U. Severo Ochoa

Leganés, , Spain

Site Status

H.G.U. G. Marañón

Madrid, , Spain

Site Status

H.U. F. Jiménez Díaz

Madrid, , Spain

Site Status

C.H. de Orense

Ourense, , Spain

Site Status

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status

H.U. Sant Joan de Reus

Reus, , Spain

Site Status

C.H.U. de Canarias

Santa Cruz de Tenerife, , Spain

Site Status

H.U.N. Sra. Valme

Seville, , Spain

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Chang Gung Medical Foundation, Linkou

Taoyuan District, , Taiwan

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

ChiangMai Univerisity

Chiang Mai, , Thailand

Site Status

Chiangrai Prachanukroh Hospital

Chiang Rai, , Thailand

Site Status

Prince of Songkla University

Hat Yai, , Thailand

Site Status

Udonthani Cancer Hospital

Udon Thani, , Thailand

Site Status

Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo

Chernivtsi, , Ukraine

Site Status

Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

Dnipropetrovsk, , Ukraine

Site Status

Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

Kharkiv, , Ukraine

Site Status

Khmelnytskyi oblasnyi onkolohichnyi dyspanser

Khmelnytskyi, , Ukraine

Site Status

Odeskyi oblasnyi onkolohichnyi dyspanser

Odesa, , Ukraine

Site Status

OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"

Sumy, , Ukraine

Site Status

Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser

Vinnytsia, , Ukraine

Site Status

Zaporozhye Regional Clinical Oncology Center

Zaporizhzhya, , Ukraine

Site Status

Countries

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Belarus Georgia Germany Hungary Poland Romania Russia Serbia South Korea Spain Taiwan Thailand Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SB8-G31-NSCLC

Identifier Type: -

Identifier Source: org_study_id