Shparyk, Yaroslav V. and Bondarenko, Igor and Paravisini, Alexandra and Florez, Amalia and Huerga, Camino and Abad, Marta and Bullo, Felicitas and Millan, Susana (2019) Bevacizumab biosimilar and reference bevacizumab in subjects with stage IIIB/IV non-squamous non-small cell lung cancer (STELLA): Design of a confirmatory, double-blind, randomized, controlled study. Journal of Clinical Oncology, 37 (15supp). e20731-e20731. ISSN 1527-7755 (online, version of record) and 0732-183X (print)
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Abstract
Background: MB02 is a bevacizumab biosimilar developed to stringent guidelines, including non-clinical and preclinical investigations and a clinical trial as first-line treatment in metastatic colorectal cancer (Romera A et al. Lancet Gastroenterol Hepatol 2018;3 (12): 845-855). A clinical trial (STELLA) has been initiated to confirm there are no clinically meaningful differences between MB02 and reference bevacizumab (Avastin) in terms of efficacy, safety, and immunogenicity (NCT03296163). Methods: STELLA study is a multinational, double-blind, randomized, parallel-group, equivalence study comparing the efficacy and safety of MB02 vs reference bevacizumab plus chemotherapy in subjects with stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC).
| Item Type: | Article |
|---|---|
| Additional Information: | ARTICLE CITATION DOI: 10.1200/JCO.2019.37.15_suppl.e20731 Journal of Clinical Oncology 37, no. 15_suppl Published online May 26, 2019. |
| Subjects: | Oncology |
| Divisions: | Departments > Department of Oncology and Medical Radiology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 03 Jun 2020 11:52 |
| Last Modified: | 03 Jun 2020 11:52 |
| URI: | http://repo.dma.dp.ua/id/eprint/5429 |
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