12.Oct.2016

First-patient-in milestone reached in a phase III clinical oncological trial

This is a phase III, randomised, double-blind, multicenter study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of the investigational medicinal drug.

The primary objective of the study is to demonstrate the equivalence of the investigational drug to the reference medication in terms of the best overall response rate by 24 weeks of chemotherapy in subjects with metastatic or recurrent non-squamous non-small cell lung cancer.

A total of approximately 700 patients will be enrolled into this study and equally divided into treatment arms. The recruitment is expected to last about 2 years. As of now, 13 investigational sites have been initiated and about 30 patients have been randomized. 

Lung cancer is the second most common cancer in men and the third most common in women, accounting for about 13% of cancer diagnoses, but it is the leading cause of cancer-related deaths in industrialized countries. In Europe 2012, estimated new cases of lung cancer are 410,000 and deaths from lung cancer are 353,000. The 5-year relative survival rate varies depending on the stage at diagnosis, from 22.9% to 2.8% for patients with local and distant stage disease, respectively.According to the publications, the vast majority (85%) of cases of lung cancer are due to long-term tobacco smoking. About 10–15% of cases occur in people who have never smoked. These cases are often caused by a combination of genetic factors and exposure to radon gas, asbestos, second-hand smoke, or other forms of air pollution.

In this project the OCT team is responsible for regulatory support and logistic issues, meetings of investigators, project management, clinical monitoring and cooperation with investigational sites.

Oncological trials make up a considerable part of OCT’s portfolio with more than 60 successfully completed research projects in this therapeutic area. In 11 years of work, OCT conducted over 200 clinical trials for a wide variety of indications. Our range of services covers a full spectrum of activities related to organization and conduct of phase I-IV trials and BE trials.