Clinical trial NCT02754882: A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: NSCLC
bevacizumab
avastin
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks
timeFrame: 24 weeks from randomisation
Secondary outcomes:
measure: Progression Free Survival
timeFrame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
measure: Overall Survival
timeFrame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
measure: Duration of Response (DoR)
timeFrame: from documented tumour response until disease progression up to 12 months from randomisation of the last subject
measure: Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
timeFrame: AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation.
measure: Pharmacokinetics: Trough Level [Ctrough]
timeFrame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax]
timeFrame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
measure: Immunogenicity Assessments (Anti-drug Antibodies)
timeFrame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.
measure: Immunogenicity Assessments (Neutralizing Antibodies)
timeFrame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.
Other outcomes:
measure: Best Objective Response Rate by 11 and 17 Weeks
timeFrame: 11 weeks and 17 weeks from randomisation
Locations:
city: Brest
country: Belarus
facility: Brest Regional Oncology Dispensary
city: Grodno
country: Belarus
facility: Grodno Regional Clinical Hospital
city: Lesnoy
country: Belarus
facility: N. N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
city: Minsk
country: Belarus
facility: Minsk city Clinical Oncological Dispensary
city: Mogilev
country: Belarus
facility: Mogilev Regional Oncological Dispensary
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncological Dispensary
city: Batumi
country: Georgia
facility: JSC Maritime Hospital
city: Kutaisi
country: Georgia
facility: JSC Saint Nikolozi Surgery Center
city: Tbilisi
country: Georgia
facility: LTD Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: ICO-Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: New Vision University Hospital
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: Institute for Personalized Medicine LTD
city: Tbilisi
country: Georgia
facility: LTD Chemotherapy and Immunotherapy Clinic Medulla
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH
city: Homburg
country: Germany
facility: University Hospital Homburg
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig [Pneumologie]
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Löwenstein
country: Germany
facility: Klinik Löwenstein
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Budapest
country: Hungary
facility: Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel
city: Deszk
country: Hungary
facility: Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon-si
country: Korea, Republic of
facility: Catholic University of Korea, St. Vincent's Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei Universtiy, Wonju Severance Christian Hospital
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Poznan
country: Poland
facility: MED-POLONIA Sp.z o.o.
city: Bucuresti
country: Romania
facility: Med Life
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Cluj-Napoca
country: Romania
facility: Medisprof
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Constanta
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
city: Craiova
country: Romania
facility: Oncolab
city: Floresti
country: Romania
facility: Radiotherapy Center CJ radioterapie si chimioterapie adulti
city: Iasi
country: Romania
facility: Centrul de Oncologie Euroclinic
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Oradea
country: Romania
facility: Pelican Impex
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica
city: Arkhangelsk
country: Russian Federation
facility: State Budgetary Institution of Arkhangelsk Oblast "Arkhangelsk Region Clinical Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"
city: Kazan
country: Russian Federation
facility: State Autonomous Healthcare Institution "Republican Clinical Oncology Center of Ministry of Healthcare of Tatarstan Republic"
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution "Regional Clinical Hospital #1 n.a. professor S.V. Ochapovsky" of Ministry of Healthcare of Krasnodar Region
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution " N.N. Blokhin Russian Cancer Research Center" of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Autonomous Healthcare Institution of Moscow "Moscow City Oncology Hospital # 62 of Healthcare Department of Moscow"
city: Murmansk
country: Russian Federation
facility: State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of Nizhny Novgorod oblast "Nizhny Novgorod Region Oncology Center"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncology Center"
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"
city: Saint-Petersburg
country: Russian Federation
facility: Federal Budgetary Healthcare Insittution "Saint-Petersburg Clinical Hospital of RAS"
city: Saint-Petersburg
country: Russian Federation
facility: State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: 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
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution " Scientific Research Institute of Oncology n.a. N.N. Petrov" of Ministry of Healthcare of the Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Center"
city: Samara
country: Russian Federation
facility: Private foundation of Educational establishment of Higher Education Medical University "REAVIZ"
city: Sochi
country: Russian Federation
facility: State Budgetary Healthcare Institution " Oncology Center #2" of Krasnodar Region Ministry of Healthcare
city: Ufa
country: Russian Federation
facility: State Budgetary Healthcare Institution Republican Clinical Oncology Center of Ministry of Healthcare of the Republic of Bashkortostan
city: Volzhskiy
country: Russian Federation
facility: State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
city: Yekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovskaya Oblast "Sverdlovsk Regional Oncology Center"
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic for Pulmology
city: Nis
country: Serbia
facility: Clinical Centre Nis
city: Castelló de la Plana
country: Spain
facility: C.H. Provincial de Castellón
city: Leganés
country: Spain
facility: H.U. Severo Ochoa
city: Madrid
country: Spain
facility: H.G.U. G. Marañón
city: Madrid
country: Spain
facility: H.U. F. Jiménez Díaz
city: Ourense
country: Spain
facility: C.H. de Orense
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Reus
country: Spain
facility: H.U. Sant Joan de Reus
city: Santa Cruz de Tenerife
country: Spain
facility: C.H.U. de Canarias
city: Sevilla
country: Spain
facility: H.U.N. Sra. Valme
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: ChiangMai Univerisity
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
city: Udon Thani
country: Thailand
facility: Udonthani Cancer Hospital
city: Chernivtsi
country: Ukraine
facility: Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo
city: Dnipropetrovsk
country: Ukraine
facility: Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
city: Kharkiv
country: Ukraine
facility: Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi oblasnyi onkolohichnyi dyspanser
city: Odesa
country: Ukraine
facility: Odeskyi oblasnyi onkolohichnyi dyspanser
city: Sumy
country: Ukraine
facility: OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"
city: Vinnytsia
country: Ukraine
facility: Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser
city: Zaporozhye
country: Ukraine
facility: Zaporozhye Regional Clinical Oncology Center
Study officials:
affiliation: LungenClinic Grosshansdorf, Germany
name: Martin Reck, M.D.
role: PRINCIPAL_INVESTIGATOR
References: