GCT has been awarded the international multicenter phase III clinical trial of a tumor-starving (anti-angiogenic) therapy. The global enrollment target is 608 patients diagnosed with Non-Small Cell Lung Cancer. The first patient was randomized by GCT in the U.S. beginning of 2021.
Lung cancer is the leading cause of cancer death in the United States and worldwide. NSCLC is a group of lung cancers that behave similarly, such as squamous cell carcinoma and adenocarcinoma.
GCT has identified and qualified over 100 sites globally. Our regional teams have been initiating start-up activities: while working closely with sites on feasibility, SQVs, and agreements, submission dossiers were completed and submitted to several regulatory authorities’ review last month.
“We are honored to run this project, which we hope will get our client’s product to the very competitive market of biosimilars. We did feasibility in 30+ countries and believe that the selected regions will be able to deliver maximum results within the required timelines”, Eugene Selivra, MD, Chief Executive Officer.
The services are being provided by GCT include ex-US regulatory affairs, IRB and local ethics committee submissions, clinical monitoring, project management, vendor management, safety and pharmacovigilance support, medical monitoring, clinical supply logistics support.