OCT is happy to announce that we have been granted a phase III clinical trial of a biosimilar for treatment of metastatic non-squamous non-small cell lung cancer sponsored by one internationally-renowned pharmaceutical company.
This is a phase III, randomized, comparative, double-blind, two-parallel group, multicenter study assessing the efficacy, safety, pharmacokinetics and immunogenicity of the investigational medicinal product (biosimilar) and the reference drug in subjects with EGFR wild-type metastatic non-squamous non-small cell lung cancer. The Sponsor of this study is a large world-known Asian pharmaceutical company which intends to obtain a marketing authorization for its own biosimilar product in Russia.
A total of 263 patients diagnosed with EGFR wild-type metastatic non-squamous non-small cell lung cancer are expected to be enrolled, 210 of which will be randomized for the current trial. Approximately 17 investigational sites are planned to be initiated in the study in Russia.
OCT is planning to perform the initial submission to the Ministry of Healthcare of the Russian Federation in December 2015. The study is expected to be initiated in April 2016 and to be completed by October 2019. Patients’ enrollment is expected to be completed by February 2018.
This is a full-service clinical project in which OCT will provide full regulatory and investigational support including site selection, regulatory assistance, submissions to local ethics committees, execution of CTAs with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics and quality assurance support, obtaining of an import license for study drug and an export license for biosamples shipment. OCT will be also be managing the selection, contract execution, payments and interaction with warehouses.
OCT has in-depth expertise in organization and conduct of phase III (pivotal) clinical trials. Since its establishment in 2005 OCT has successfully completed 55 phase III studies, including oncology studies in non-small cell lung cancer patients. Our long-term collaboration with leading experts and considerable experience in this therapeutic area allows us to achieve high enrollment rates and best quality of clinical data.