Samsung Bioepis, one of the world's leading biopharmaceutical companies, ran a clinical trial for its own biosimilar product in 13 countries. OCT Clinical was contracted as a local CRO and was responsible for running full-scale clinical trial activities with the recruitment goal of 254 patients across 21 research sites. Whereas the the Global CRO recruited 509 patients at 79 sites in countries, including Germany, Spain, Serbia, Georgia, South Korea and Taiwan.
This was a Phase III, randomized, comparative, double-blind, two-parallel group, multicenter study in subjects with metastatic or recurrent non-squamous non-small cell lung cancer. The aim of the study was to demonstrate the efficacy, safety, pharmacokinetics, and immunogenicity of the of the investigational drug (biosimilar) compared to a comparator during a 24-week chemotherapy period.