15.Jun.2016

Approval obtained for a phase III clinical trial in patients with lung cancer

This is a phase III, randomised, double-blind, multicentre study to estimate the efficacy, safety, pharmacokinetics and immunogenicity of the study drug.

The primary objective of the trial is to demonstrate the equivalence of reference and investigational drugs 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 divided in equal treatment groups. Recruitment is expected to last about 2 years.

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 industrialised 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.

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

A considerable part of OCT’s portfolio is represented by clinical trials in oncology. The team has completed about 60 studies in this nosology and has an in-depth expertise of such projects’ specificity. Find out more about our experience.