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

NCT02754882 | Completed Phase 3 Results DMC

• 1 other identifier: SB8-G31-NSCLC
• Study Type: interventional
• Target: 763
• Locations: 13 countries
• Sites: 105

Brief 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).

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Keywords

NSCLC; bevacizumab; avastin

Outcome Measures

Primary Outcomes (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.

  24 weeks from randomisation

Secondary Outcomes (8)

• Progression Free Survival

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

• Overall Survival

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

• Duration of Response (DoR)

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

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

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

• Pharmacokinetics: Trough Level [Ctrough]

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

Other Outcomes (1)

• Best Objective Response Rate by 11 and 17 Weeks

  11 weeks and 17 weeks from randomisation

Study Arms (2)

Bevacizumab (Avastin)

ACTIVE COMPARATOR

Avastin® + Carboplatin/Paclitaxel

Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

SB8 (A proposed bevacizumab biosimilar)

EXPERIMENTAL

SB8 + Carboplatin/Paclitaxel

Drug: SB8; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

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

Also known as: Avastin®

Bevacizumab (Avastin)

SB8 DRUG

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

Also known as: SB8 (A proposed bevacizumab biosimilar)

SB8 (A proposed bevacizumab biosimilar)

Carboplatin DRUG

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

Bevacizumab (Avastin); SB8 (A proposed bevacizumab biosimilar)

Paclitaxel DRUG

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

Also known as: Taxol

Bevacizumab (Avastin); SB8 (A proposed bevacizumab biosimilar)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (105)

Brest Regional Oncology Dispensary

Brest, 224027, Belarus

Location

Grodno Regional Clinical Hospital

Grodno, 230017, Belarus

Location

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

Lesnoy, 223040, Belarus

Location

Minsk city Clinical Oncological Dispensary

Minsk, 220013, Belarus

Location

Mogilev Regional Oncological Dispensary

Mogilev, 212018, Belarus

Location

Vitebsk Regional Clinical Oncological Dispensary

Vitebsk, 210603, Belarus

Location

JSC Maritime Hospital

Batumi, 6010, Georgia

Location

JSC Saint Nikolozi Surgery Center

Kutaisi, 4600, Georgia

Location

LTD Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

ICO-Institute of Clinical Oncology

Tbilisi, 0159, Georgia

Location

New Vision University Hospital

Tbilisi, 0159, Georgia

Location

LTD MediClubGeorgia

Tbilisi, 0160, Georgia

Location

Institute for Personalized Medicine LTD

Tbilisi, 0186, Georgia

Location

LTD Chemotherapy and Immunotherapy Clinic Medulla

Tbilisi, 0186, Georgia

Location

Evangelisches Krankenhaus Bielefeld

Bielefeld, 33611, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

University Hospital Homburg

Homburg, 66421, Germany

Location

Klinikum Kassel

Kassel, 34125, Germany

Location

Universitätsklinikum Leipzig [Pneumologie]

Leipzig, 04103, Germany

Location

Klinik Löwenstein

Löwenstein, 74245, Germany

Location

Klinikum der Stadt Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, 1121, Hungary

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, 1521, Hungary

Location

Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel

Budapest, H-1529, Hungary

Location

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

Deszk, 6772, Hungary

Location

Veszprem Megyei Onkormanyzat Tudogyogyintezete

Farkasgyepű, 8582, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

Szolnok, 5004, Hungary

Location

Markusovszky Egyetemi Oktatókórház

Szombathely, H-9700, Hungary

Location

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, 05-400, Poland

Location

MED-POLONIA Sp.z o.o.

Poznan, 60-693, Poland

Location

Med Life

Bucharest, 031784, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Medisprof

Cluj-Napoca, 400058, Romania

Location

Spitalul Clinic Judetean de Urgenta Constanta

Constanța, 900591, Romania

Location

Centrul de Oncologie Sf. Nectarie

Craiova, 200347, Romania

Location

Oncolab

Craiova, 200385, Romania

Location

Radiotherapy Center CJ radioterapie si chimioterapie adulti

Floreşti, 407280, Romania

Location

Centrul de Oncologie Euroclinic

Iași, 700106, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Pelican Impex

Oradea, 410469, Romania

Location

Oncocenter Oncologie Clinica

Timișoara, 300210, Romania

Location

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

Arkhangelsk, 163045, Russia

Location

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"

Chelyabinsk, 454087, Russia

Location

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

Kazan', 420029, Russia

Location

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

Krasnodar, 350086, Russia

Location

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

Moscow, 115478, Russia

Location

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

Moscow, 143423, Russia

Location

State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"

Murmansk, 183047, Russia

Location

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

Nizhny Novgorod, 603081, Russia

Location

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

Novosibirsk, 630108, Russia

Location

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

Omsk, 644013, Russia

Location

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

Saint Petersburg, 194017, Russia

Location

State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital

Saint Petersburg, 194291, Russia

Location

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, Russia

Location

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, Russia

Location

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

Saint Petersburg, 198255, Russia

Location

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

Samara, 443011, Russia

Location

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

Sochi, 354057, Russia

Location

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

Ufa, 450054, Russia

Location

State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"

Volzhskiy, 404130, Russia

Location

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

Yaroslavl, 150040, Russia

Location

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

Yekaterinburg, 620036, Russia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11070, Serbia

Location

Clinical Center Kragujevac, Clinic for Pulmology

Kragujevac, 34000, Serbia

Location

Clinical Centre Nis

Niš, 18000, Serbia

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Catholic University of Korea, St. Vincent's Hospital

Suwon, 442-723, South Korea

Location

Yonsei Universtiy, Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

C.H. Provincial de Castellón

Castellon, 12002, Spain

Location

H.U. Severo Ochoa

Leganés, 28911, Spain

Location

H.G.U. G. Marañón

Madrid, 28007, Spain

Location

H.U. F. Jiménez Díaz

Madrid, 28040, Spain

Location

C.H. de Orense

Ourense, 32005, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

H.U. Sant Joan de Reus

Reus, 43204, Spain

Location

C.H.U. de Canarias

Santa Cruz de Tenerife, 38320, Spain

Location

H.U.N. Sra. Valme

Seville, 41014, Spain

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

E-Da Hospital

Kaohsiung City, 824, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Chang Gung Medical Foundation, Linkou

Taoyuan District, 33305, Taiwan

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

ChiangMai Univerisity

Chiang Mai, 50200, Thailand

Location

Chiangrai Prachanukroh Hospital

Chiang Rai, 57000, Thailand

Location

Prince of Songkla University

Hat Yai, 90110, Thailand

Location

Udonthani Cancer Hospital

Udon Thani, 41330, Thailand

Location

Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo

Chernivtsi, 58013, Ukraine

Location

Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

Dnipropetrovsk, 49102, Ukraine

Location

Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

Kharkiv, 61070, Ukraine

Location

Khmelnytskyi oblasnyi onkolohichnyi dyspanser

Khmelnytskyi, 29009, Ukraine

Location

Odeskyi oblasnyi onkolohichnyi dyspanser

Odesa, 65055, Ukraine

Location

OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"

Sumy, 40022, Ukraine

Location

Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser

Vinnytsia, 21029, Ukraine

Location

Zaporozhye Regional Clinical Oncology Center

Zaporizhzhya, 69040, Ukraine

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

031-8061-1096

Study Officials

• Martin Reck, M.D.

  LungenClinic Grosshansdorf, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 28, 2016
• Study Start: July 5, 2016
• Primary Completion: January 24, 2018
• Study Completion: October 9, 2018
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (7); BE (6); ES (9); KR (10); TW (5); PL (3); DE (8); RU (21); SE (4); TH (5); UA (8); RO (11); GE (8)