Success story in Oncology

Therapeutic area: Non-small cell lung cancer

Lung cancer is the most common cause of cancer-related mortality in developed nations, with an estimated 1.2 million new cases diagnosed each year and 1 million deaths annually worldwide. In 2009 were identified 60,337 cases of Non-small cell lung cancer in Russia. The majority of patients with non-small cell lung cancer (NSCLC) present with advanced disease, and first- and second-line chemotherapy yield modest improvements in survival and symptom control, with recent evidence to support similar benefits in the third-line setting in selected patients with epidermal growth factor tyrosine kinase inhibitors.

Study sponsored by: a leading American pharmaceutical company

The controlled study of IMP given in combination with standard paclitaxel/carboplatin chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.

Study design:  a randomized, double blind, placebo controlled study 

Number of involved countries: 8 countries (EU and Russia).

Planned randomized  patients for involved countries: 150 patients
Client goal: enrollment of additional 32 subjects in Russia during 21 days.
Challenge: complex protocol
Number of sites in Russia: 8 site.

 

Results:

1. The recruitment program exceeded expectations of the client, enrolling 32 subjects in only 21 days (see diagram). The sponsor thanked the investigator for granting his support for the study in spite of the short time of his disposal.

2. Our Company had the most number of enrolled subjects - 21%, compared to seven other European countries.