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.
More than 200 patients is to be enrolled in Russia. OCT provided successful enrollment of 50% of patients 3 months earlier than predicted.
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.
The trial is initiated by the international sponsor. 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.