At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 763 enrolled
Drug / intervention
Bevacizumab +3 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.
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
In Brief
A Phase 3 clinical trial evaluating Bevacizumab, SB8, and 2 other interventions for Lung Cancer and Non-small Cell Lung Cancer. Completed, enrolled 763 participants across 105 sites in 13 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Non-small Cell Lung Cancer
CountriesBelarus, Georgia, Germany, Hungary, Poland, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionJan 2018
Study CompletionOct 2018
TodayJul 2026
First PostedApr 28, 2016
Enrollment StartJul 5, 2016
Primary CompletionJan 24, 2018
Study CompletionOct 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago
Interventions
Bevacizumabdrug
Avastin® 15 mg/kg IV every 3 weeks on Day 1
SB8drug
SB8 15 mg/kg IV every 3 weeks on Day 1
Carboplatindrug
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Paclitaxeldrug
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles