CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 353 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01763645
NCT01763645Phase 3Completed
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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

Biocad·interventional·Posted Jan 9, 2013·Updated Jan 11, 2024

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Paclitaxel, and 1 other intervention for Non-small Cell Lung Cancer. Completed, enrolled 353 participants across 44 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesBelarus, India, Russia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2013
Enrollment StartOct 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.5 years ago

Interventions

Bevacizumabdrug

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).

Paclitaxeldrug

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)

Carboplatindrug

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).