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

Primary Purpose

Lung Cancer, Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
SB8
Carboplatin
Paclitaxel
Sponsored by
Samsung Bioepis Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring NSCLC, bevacizumab, avastin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bevacizumab (Avastin)

SB8 (A proposed bevacizumab biosimilar)

Arm Description

Avastin® + Carboplatin/Paclitaxel

SB8 + Carboplatin/Paclitaxel

Outcomes

Primary Outcome Measures

Best Objective Response Rate by 24 weeks
Any PR or CR prior to the 24th week will be marked as response

Secondary Outcome Measures

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
Overall Survival
OS from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
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
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.
Pharmacokinetics: Trough Level [Ctrough]
Ctrough at selected cycles
Pharmacokinetics: Maximum Plasma Concentration [Cmax]
Cmax at selected cycles
Immunogenicity Assessments (Anti-drug Antibodies)
Incidence of anti-drug (bevacizumab) antibodies (ADA)
Immunogenicity Assessments (Neutralizing Antibodies)
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)

Full Information

First Posted
March 24, 2016
Last Updated
January 2, 2019
Sponsor
Samsung Bioepis Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02754882
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell Lung Cancer
Keywords
NSCLC, bevacizumab, avastin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
763 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab (Avastin)
Arm Type
Active Comparator
Arm Description
Avastin® + Carboplatin/Paclitaxel
Arm Title
SB8 (A proposed bevacizumab biosimilar)
Arm Type
Experimental
Arm Description
SB8 + Carboplatin/Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin®
Intervention Description
Avastin® 15 mg/kg IV every 3 weeks on Day 1
Intervention Type
Drug
Intervention Name(s)
SB8
Other Intervention Name(s)
SB8 (A proposed bevacizumab biosimilar)
Intervention Description
SB8 15 mg/kg IV every 3 weeks on Day 1
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Primary Outcome Measure Information:
Title
Best Objective Response Rate by 24 weeks
Description
Any PR or CR prior to the 24th week will be marked as response
Time Frame
24 weeks from randomisation
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Time Frame
from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Title
Overall Survival
Description
OS from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Time Frame
from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Title
Duration of Response
Description
DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Time Frame
from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Title
Incidence of Treatment-related Adverse Events using CTCAE v4.03
Description
After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
Time Frame
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.
Title
Pharmacokinetics: Trough Level [Ctrough]
Description
Ctrough at selected cycles
Time Frame
Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Title
Pharmacokinetics: Maximum Plasma Concentration [Cmax]
Description
Cmax at selected cycles
Time Frame
Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Title
Immunogenicity Assessments (Anti-drug Antibodies)
Description
Incidence of anti-drug (bevacizumab) antibodies (ADA)
Time Frame
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.)
Title
Immunogenicity Assessments (Neutralizing Antibodies)
Description
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
Time Frame
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.)
Other Pre-specified Outcome Measures:
Title
Best Objective Response Rate by 11 and 17 weeks
Description
Best ORR by 11 weeks and 17 weeks
Time Frame
11 weeks and 17 weeks from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Reck, M.D.
Organizational Affiliation
LungenClinic Grosshansdorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest Regional Oncology Dispensary
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Grodno Regional Clinical Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
N. N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Minsk city Clinical Oncological Dispensary
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Mogilev Regional Oncological Dispensary
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncological Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
JSC Maritime Hospital
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
JSC Saint Nikolozi Surgery Center
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
LTD Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
ICO-Institute of Clinical Oncology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
New Vision University Hospital
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD MediClubGeorgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Institute for Personalized Medicine LTD
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
LTD Chemotherapy and Immunotherapy Clinic Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
LungenClinic Grosshansdorf GmbH
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
University Hospital Homburg
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Universitätsklinikum Leipzig [Pneumologie]
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinik Löwenstein
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1521
Country
Hungary
Facility Name
Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel
City
Budapest
ZIP/Postal Code
H-1529
Country
Hungary
Facility Name
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Veszprem Megyei Onkormanyzat Tudogyogyintezete
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Yonsei Universtiy, Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
MED-POLONIA Sp.z o.o.
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Med Life
City
Bucuresti
ZIP/Postal Code
031784
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Medisprof
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Centrul de Oncologie Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Oncolab
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Radiotherapy Center CJ radioterapie si chimioterapie adulti
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Facility Name
Centrul de Oncologie Euroclinic
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Pelican Impex
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Oncocenter Oncologie Clinica
City
Timisoara
ZIP/Postal Code
300210
Country
Romania
Facility Name
State Budgetary Institution of Arkhangelsk Oblast "Arkhangelsk Region Clinical Oncology Center
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution "Republican Clinical Oncology Center of Ministry of Healthcare of Tatarstan Republic"
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Regional Clinical Hospital #1 n.a. professor S.V. Ochapovsky" of Ministry of Healthcare of Krasnodar Region
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution " N.N. Blokhin Russian Cancer Research Center" of the Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Moscow "Moscow City Oncology Hospital # 62 of Healthcare Department of Moscow"
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center"
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Nizhny Novgorod oblast "Nizhny Novgorod Region Oncology Center"
City
Nizhniy Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncology Center"
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Federal Budgetary Healthcare Insittution "Saint-Petersburg Clinical Hospital of RAS"
City
Saint-Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Center"
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Private foundation of Educational establishment of Higher Education Medical University "REAVIZ"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution " Oncology Center #2" of Krasnodar Region Ministry of Healthcare
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution Republican Clinical Oncology Center of Ministry of Healthcare of the Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center"
City
Volzhskiy
ZIP/Postal Code
404130
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Sverdlovskaya Oblast "Sverdlovsk Regional Oncology Center"
City
Yekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic for Pulmology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Centre Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
C.H. Provincial de Castellón
City
Castelló de la Plana
ZIP/Postal Code
12002
Country
Spain
Facility Name
H.U. Severo Ochoa
City
Leganés
ZIP/Postal Code
28911
Country
Spain
Facility Name
H.G.U. G. Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H.U. F. Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
C.H. de Orense
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
H.U. Sant Joan de Reus
City
Reus
ZIP/Postal Code
43204
Country
Spain
Facility Name
C.H.U. de Canarias
City
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
H.U.N. Sra. Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
E-Da Hospital
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Linkou
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
ChiangMai Univerisity
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Chiangrai Prachanukroh Hospital
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Prince of Songkla University
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Udonthani Cancer Hospital
City
Udon Thani
ZIP/Postal Code
41330
Country
Thailand
Facility Name
Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Khmelnytskyi oblasnyi onkolohichnyi dyspanser
City
Khmelnytskyi
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
Odeskyi oblasnyi onkolohichnyi dyspanser
City
Odesa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser"
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical Oncology Center
City
Zaporozhye
ZIP/Postal Code
69040
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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