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.
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.
