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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754882
• Other study ID #: SB8-G31-NSCLC
• Status: Completed
• Phase: Phase 3
• Start date: July 5, 2016
• Est. completion date: October 9, 2018

Study information

• Verified date: January 2019
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: October 9, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Bevacizumab
Avastin® 15 mg/kg IV every 3 weeks on Day 1
• SB8
SB8 15 mg/kg IV every 3 weeks on Day 1
• Carboplatin
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
• Paclitaxel
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Locations

Country	Name	City	State
Belarus	Brest Regional Oncology Dispensary	Brest
Belarus	Grodno Regional Clinical Hospital	Grodno
Belarus	N. N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology	Lesnoy
Belarus	Minsk city Clinical Oncological Dispensary	Minsk
Belarus	Mogilev Regional Oncological Dispensary	Mogilev
Belarus	Vitebsk Regional Clinical Oncological Dispensary	Vitebsk
Georgia	JSC Maritime Hospital	Batumi
Georgia	JSC Saint Nikolozi Surgery Center	Kutaisi
Georgia	ICO-Institute of Clinical Oncology	Tbilisi
Georgia	Institute for Personalized Medicine LTD	Tbilisi
Georgia	LTD Chemotherapy and Immunotherapy Clinic Medulla	Tbilisi
Georgia	LTD MediClubGeorgia	Tbilisi
Georgia	LTD Research Institute of Clinical Medicine	Tbilisi
Georgia	New Vision University Hospital	Tbilisi
Germany	Evangelisches Krankenhaus Bielefeld	Bielefeld
Germany	Universitätsklinikum Bonn	Bonn
Germany	LungenClinic Grosshansdorf GmbH	Grosshansdorf
Germany	University Hospital Homburg	Homburg
Germany	Klinikum Kassel	Kassel
Germany	Universitätsklinikum Leipzig [Pneumologie]	Leipzig
Germany	Klinik Löwenstein	Löwenstein
Germany	Klinikum der Stadt Ludwigshafen	Ludwigshafen
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel	Budapest
Hungary	Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó	Deszk
Hungary	Veszprem Megyei Onkormanyzat Tudogyogyintezete	Farkasgyepu
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint	Szolnok
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju-si
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Catholic University of Korea, St. Vincent's Hospital	Suwon-si
Korea, Republic of	Yonsei Universtiy, Wonju Severance Christian Hospital	Wonju
Poland	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock
Poland	MED-POLONIA Sp.z o.o.	Poznan
Romania	Med Life	Bucuresti
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Medisprof	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Constanta	Constanta
Romania	Centrul de Oncologie Sf. Nectarie	Craiova
Romania	Oncolab	Craiova
Romania	Radiotherapy Center CJ radioterapie si chimioterapie adulti	Floresti
Romania	Centrul de Oncologie Euroclinic	Iasi
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Pelican Impex	Oradea
Romania	Oncocenter Oncologie Clinica	Timisoara
Russian Federation	State Budgetary Institution of Arkhangelsk Oblast "Arkhangelsk Region Clinical Oncology Center	Arkhangelsk
Russian Federation	State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"	Chelyabinsk
Russian Federation	State Autonomous Healthcare Institution "Republican Clinical Oncology Center of Ministry of Healthcare of Tatarstan Republic"	Kazan
Russian Federation	State Budgetary Healthcare Institution "Regional Clinical Hospital #1 n.a. professor S.V. Ochapovsky" of Ministry of Healthcare of Krasnodar Region	Krasnodar
Russian Federation	Federal State Budgetary Scientific Institution " N.N. Blokhin Russian Cancer Research Center" of the Ministry of Health of the Russian Federation	Moscow
Russian Federation	State Autonomous Healthcare Institution of Moscow "Moscow City Oncology Hospital # 62 of Healthcare Department of Moscow"	Moscow
Russian Federation	State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"	Murmansk
Russian Federation	State Budgetary Healthcare Institution of Nizhny Novgorod oblast "Nizhny Novgorod Region Oncology Center"	Nizhniy Novgorod
Russian Federation	State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncology Center"	Novosibirsk
Russian Federation	Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"	Omsk
Russian Federation	Federal Budgetary Healthcare Insittution "Saint-Petersburg Clinical Hospital of RAS"	Saint-Petersburg
Russian Federation	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
Russian Federation	Federal State Budgetary Institution " Scientific Research Institute of Oncology n.a. N.N. Petrov" of Ministry of Healthcare of the Russian Federation	Saint-Petersburg
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Center"	Saint-Petersburg
Russian Federation	State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital	Saint-Petersburg
Russian Federation	Private foundation of Educational establishment of Higher Education Medical University "REAVIZ"	Samara
Russian Federation	State Budgetary Healthcare Institution " Oncology Center #2" of Krasnodar Region Ministry of Healthcare	Sochi
Russian Federation	State Budgetary Healthcare Institution Republican Clinical Oncology Center of Ministry of Healthcare of the Republic of Bashkortostan	Ufa
Russian Federation	State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"	Volzhskiy
Russian Federation	State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl
Russian Federation	State Budgetary Healthcare Institution of Sverdlovskaya Oblast "Sverdlovsk Regional Oncology Center"	Yekaterinburg
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Center Kragujevac, Clinic for Pulmology	Kragujevac
Serbia	Clinical Centre Nis	Nis
Spain	C.H. Provincial de Castellón	Castelló de la Plana
Spain	H.U. Severo Ochoa	Leganés
Spain	H.G.U. G. Marañón	Madrid
Spain	H.U. F. Jiménez Díaz	Madrid
Spain	C.H. de Orense	Ourense
Spain	Clínica Universidad de Navarra	Pamplona
Spain	H.U. Sant Joan de Reus	Reus
Spain	C.H.U. de Canarias	Santa Cruz de Tenerife
Spain	H.U.N. Sra. Valme	Sevilla
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chang Gung Medical Foundation, Linkou	Taoyuan
Thailand	Siriraj Hospital	Bangkok
Thailand	ChiangMai Univerisity	Chiang Mai
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai
Thailand	Prince of Songkla University	Hat Yai
Thailand	Udonthani Cancer Hospital	Udon Thani
Ukraine	Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo	Chernivtsi
Ukraine	Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4	Dnipropetrovsk
Ukraine	Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr	Kharkiv
Ukraine	Khmelnytskyi oblasnyi onkolohichnyi dyspanser	Khmelnytskyi
Ukraine	Odeskyi oblasnyi onkolohichnyi dyspanser	Odesa
Ukraine	OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"	Sumy
Ukraine	Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser	Vinnytsia
Ukraine	Zaporozhye Regional Clinical Oncology Center	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Belarus,  Georgia,  Germany,  Hungary,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best Objective Response Rate by 11 and 17 weeks	Best ORR by 11 weeks and 17 weeks	11 weeks and 17 weeks from randomisation
Primary	Best Objective Response Rate by 24 weeks	Any PR or CR prior to the 24th week will be marked as response	24 weeks from randomisation
Secondary	Progression Free Survival	PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject	from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Secondary	Overall Survival	OS from the date of randomisation to the date of death up to 12 months from randomisation of the last subject	from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Secondary	Duration of Response	DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject	from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Secondary	Incidence of Treatment-related Adverse Events using CTCAE v4.03	After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.	AEs will be reported from the time the informed consent form (ICF) is signed until the EOT visit. The expected EOT visit for a final subject is approximately 30 months from study initiation.
Secondary	Pharmacokinetics: Trough Level [Ctrough]	Ctrough at selected cycles	Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Secondary	Pharmacokinetics: Maximum Plasma Concentration [Cmax]	Cmax at selected cycles	Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Secondary	Immunogenicity Assessments (Anti-drug Antibodies)	Incidence of anti-drug (bevacizumab) antibodies (ADA)	Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.)
Secondary	Immunogenicity Assessments (Neutralizing Antibodies)	Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)	Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.)