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
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
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).
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.
Inclusion Criteria:
Exclusion Criteria:
Lesnoy, 223040, Belarus
Arkhangelsk, 163045, Russia
Chelyabinsk, 454087, Russia
Kazan', 420029, Russia
Krasnodar, 350086, Russia
Moscow, 115478, Russia
Moscow, 143423, Russia
Murmansk, 183047, Russia
Nizhny Novgorod, 603081, Russia
Novosibirsk, 630108, Russia
Saint Petersburg, 194017, Russia
Saint Petersburg, 194291, Russia
Saint Petersburg, 197022, Russia
Saint Petersburg, 197758, Russia
Saint Petersburg, 198255, Russia
Samara, 443011, Russia
Sochi, 354057, Russia
Ufa, 450054, Russia
Volzhskiy, 404130, Russia
Yaroslavl, 150040, Russia
Yekaterinburg, 620036, Russia