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

PHASE3CompletedINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Bevacizumab

Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally)

DRUG

Carboplatin

Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).

Trial Locations (44)

115478

"Institution of Russian Academy of Medical Sciences Russian Cancer Research Center named after N.N. Blokhin", Moscow

143423

"State Health Institution of Moscow Moscow City Oncology Hospital #62 of Moscow Board of Health", Moscow Region

163045

Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk

183047

Murmansk Regional Oncology Dispensary, Murmansk

194044

"Federal State Institution Moscow Institute of Cancer Research named after P.A. Hertsen Ministry of Health of Russian Federation", Moscow

197022

Saint Petersburg City Clinical Oncology Center, Saint Petersburg

St. Petersburg State Medical University n.a. I. P. Pavlov, Saint Petersburg

197758

N.N.Petrov Oncology Research Center, Saint Petersburg

St. Petersburg Research and Practice Center for Secondary Care in Oncology, Saint Petersburg

302020

"Regional State Health Institution Orlov Oncology Dispansary", Oryol

305035

"State Healthcare Facility Kursk Regional Oncology Dispensary", Kursk

314019

"Federal Government Budgetary Institution Rostov Institute of Cancer Research of Ministry of Health of Russian Federation", Rostov-on-Don

354057

Oncology Dispensary 2, Sochi

355047

"State-financed Health Institution Stavropol Region Clinical Oncology Dispansary", Stavropol

394000

"State Health Institution Voronezh Region Clinical Oncology Dispansary", Voronezh

400138

Volgograd District Oncology Dispensary №1, Volgograd

404130

Volgograd Regional Oncology Dispensary №3, Volgograd

440071

"State Health Institution Region Oncology Dispansary", Penza

443031

"State-financed Health Institution Samara Region Clinical Oncology Dispansary", Samara

454000

"Non-governmental Healthcare Institution Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk

560027

HCG Bangalore Institute of Oncology, Bangalore

560054

M.S.Ramaiah Memorial Hospital, Bangalore

560099

Narayana Hrudayalaya Hospitals, Bangalore

603006

"Nizhny Novgorod Region State Budgetary Healthcare Facility Clinical Diagnostics Center", Nizhny Novgorod

614066

Perm Region Oncology Dispensary, Perm

630047

City Clinical Hospital №1, Novosibirsk

Unknown

Brest Regional Clinical Dispensary, Brest

Grodno Regional Clinical Hospital, Grodno

Gomel Regional Clinical Oncology Dispensary, Homyel

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk

"State-financed Health Institution Chelyabinsk Region Clinical Oncology Dispansary", Chelyabinsk

"State Healthcare Facility Nizhny Novgorod Regional Oncology Dispensary", Nizhny Novgorod

Military Medical Academy named after S.M. Kirov, Saint Petersburg

Russian scientific center of radiology and surgery technologies, Saint Petersburg

Donetsk City Oncology Dispensary, Donetsk

Donetsk Regional Antitumor Center, Donetsk

Kharkiv Regional Clinical Oncology Center, Kharkiv

Kryvyi Rih Oncology Dispensary, Kryvyi Rih

Lviv State Regional Cancer Diagnostic and Treatment Center, Lviv

City Hospital № 2, Makiivka

Poltava Regional Clinical Oncology Dispensary, Poltava

Zakarpatskyi Clinical Oncology Dispensary, Uzhhorod

Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia

Zaporizhia Regional Clinical Oncology Dispensary, Zaporizhia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT01763645 - 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 | Biotech Hunter | Biotech Hunter