Spots Global Cancer Trial Database for A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
Official Title: International Multicenter Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + Carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer (NSCLC) Patients
Study ID: NCT01763645
Conditions
Study Description
Brief Summary: BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Avastin. Also study includes pharmacokinetics assessment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Brest Regional Clinical Dispensary, Brest, , Belarus
Gomel Regional Clinical Oncology Dispensary, Gomel, , Belarus
Grodno Regional Clinical Hospital, Grodno, , Belarus
Vitebsk Regional Clinical Oncology Dispensary, Vitebsk, , Belarus
HCG Bangalore Institute of Oncology, Bangalore, , India
M.S.Ramaiah Memorial Hospital, Bangalore, , India
Narayana Hrudayalaya Hospitals, Bangalore, , India
Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk, , Russian Federation
State-financed Health Institution "Chelyabinsk Region Clinical Oncology Dispansary", Chelyabinsk, , Russian Federation
State Healthcare Facility "Kursk Regional Oncology Dispensary", Kursk, , Russian Federation
State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health", Moscow Region, , Russian Federation
Institution of Russian Academy of Medical Sciences "Russian Cancer Research Center named after N.N. Blokhin", Moscow, , Russian Federation
Federal State Institution "Moscow Institute of Cancer Research named after P.A. Hertsen" Ministry of Health of Russian Federation, Moscow, , Russian Federation
Murmansk Regional Oncology Dispensary, Murmansk, , Russian Federation
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center", Nizhny Novgorod, , Russian Federation
State Healthcare Facility "Nizhny Novgorod Regional Oncology Dispensary", Nizhny Novgorod, , Russian Federation
City Clinical Hospital №1, Novosibirsk, , Russian Federation
Regional State Health Institution "Orlov Oncology Dispansary", Orel, , Russian Federation
State Health Institution "Region Oncology Dispansary", Penza, , Russian Federation
Perm Region Oncology Dispensary, Perm, , Russian Federation
Federal Government Budgetary Institution "Rostov Institute of Cancer Research" of Ministry of Health of Russian Federation, Rostov-on-Don, , Russian Federation
Saint Petersburg City Clinical Oncology Center, Saint Petersburg, , Russian Federation
State-financed Health Institution "Samara Region Clinical Oncology Dispansary", Samara, , Russian Federation
Oncology Dispensary 2, Sochi, , Russian Federation
St. Petersburg State Medical University n.a. I. P. Pavlov, St. Petersburg, , Russian Federation
St. Petersburg Research and Practice Center for Secondary Care in Oncology, St. Petersburg, , Russian Federation
N.N.Petrov Oncology Research Center, St.Petersburg, , Russian Federation
Military Medical Academy named after S.M. Kirov, St.Petersburg, , Russian Federation
Russian scientific center of radiology and surgery technologies, St.Petersburg, , Russian Federation
State-financed Health Institution "Stavropol Region Clinical Oncology Dispansary", Stavropol, , Russian Federation
Volgograd District Oncology Dispensary №1, Volgograd, , Russian Federation
Volgograd Regional Oncology Dispensary №3, Volgograd, , Russian Federation
State Health Institution "Voronezh Region Clinical Oncology Dispansary", Voronezh, , Russian Federation
Donetsk City Oncology Dispensary, Donetsk, , Ukraine
Donetsk Regional Antitumor Center, Donetsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Kryvyi Rih Oncology Dispensary, Kryvyi Rih, , Ukraine
Lviv State Regional Cancer Diagnostic and Treatment Center, Lviv, , Ukraine
City Hospital № 2, Makiivka, , Ukraine
Poltava Regional Clinical Oncology Dispensary, Poltava, , Ukraine
Zakarpatskyi Clinical Oncology Dispensary, Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia, , Ukraine
Zaporizhia Regional Clinical Oncology Dispensary, Zaporizhia, , Ukraine
Contact Details
Name: Yulia Linkova, MD, PhD
Affiliation: Director of Clinical Development Department, BIOCAD
Role: STUDY_DIRECTOR
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