Amgen Canada Obtains Authorization in 8 Weeks for Its First FAST TRACK Study on Lung Cancer at the McGill University Health Centre, Making It the First Site Activated in Canada in 9.8 weeks
Amgen Canada used CATALIS Quebec’s FAST TRACK Evaluation Service for its 20230153 Phase II study on non-small cell lung cancer (NSCLC). Through this initiative, the research team, led by Dr. Benjamin Shieh at the McGill University Health Centre (MUHC), was able to obtain a speedy launch, with an authorization time of 8 weeks and an activation time of 9.8 weeks, making the MUHC the first site activated in Canada. This breakthrough accelerates patient access to promising new treatment options.
“Our first experience with the CATALIS FAST TRACK Evaluation Service was extremely positive, delivering a significant reduction in study approval timelines. We look forward to continuing this partnership and integrating the FAST TRACK evaluation into our processes to accelerate trial activation and bring innovative treatments to patients faster.”
– Dr. Daniel Martinez, Executive Medical Director, Amgen Canada Inc.
At the MUHC: An Innovative Cancer Research Program Combining Cutting-Edge Technologies and Multidisciplinary Approaches
Dr. Benjamin Shieh, a pulmonologist as well as an interventional pulmonary medicine and lung cancer specialist, leads the MUHC research team working on the 20230153 study. The research Institute of the MUHC (The Institute) has an innovative cancer research program that integrates basic, clinical, and evaluative research. Through its use of cutting-edge technologies and a multidisciplinary approach focused on personalized medicine and understanding cancer’s mechanisms, the MUHC plays a key role in improving care and treatment for cancer patients.
“At the MUHC, clinical trials have benefited numerous Quebec patients and have also contributed to changing practice globally. The faster clinical trials can be activated, the greater the opportunity for patients to benefit from these treatments. CATALIS facilitated the activation of this trial in 9.8 weeks, making our site the first to open in Canada. This is a tremendous achievement and provides the opportunity for people in our province to access a new and promising treatment.”
– Benjamin Shieh MD, Associate Investigator, The Institute, Assistant Professor, Department of Medicine, McGill University
An Antitumor Treatment Exploiting the Vulnerability of Lung Cancer Cells
Lung cancer is the leading cause of cancer death in the province, with incidence and mortality rates among the highest in Canada¹, which highlights the urgent need to develop new treatments for this disease. Of the different types of lung cancer, non-small cell lung cancer (NSCLC) accounts for 80-85% of cases¹.
The focus of this study is a treatment Amgen developed that destroys cancer cells with an accumulation of methylthioadenosines (MTAs). MTAs are natural waste products the cell produces and must be detoxified by the methylthioadenosine phosphorylase protein (MTAP). One to two in ten people with NSCLC experience a suppression of the MTAP protein, resulting in an accumulation of MTA². This accumulation is a characteristic of cancer cells and distinguishes them from healthy cells. By specifically targeting this characteristic, the treatment under study could destroy cancer cells while preserving healthy cells.
Amgen’s 20230153 study opens up a promising avenue as an effective antitumor option against a cancer as widespread and deadly as NSCLC in the province. The study aims to recruit 200 people worldwide, including 3 in Quebec.
Are you interested in participating in this clinical trial or in other studies on lung cancer? Clinical Trials Quebec offers a free Personalized Support Service to help guide you in your search for clinical trials. You can also access Clinical Trials Quebec’s information and services hub. This site contains easy-to-understand educational content, infographics, and free tools which will help you better understand clinical research and what happens during a clinical trial. Information on Amgen’s 20230153 clinical study is available through Quebec’s Public Clinical Trials Database on Clinical Trials Quebec, and the ClinicalTrials.gov website.
If you would like more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
¹Gouvernment of Québec (2021). Lung Cancer. Available at: https://www.quebec.ca/en/health/health-issues/cancer/lung-cancer
²Sacher A, et al. Phase 1/2, Dose-expansion study of AMG 193, an MTA-cooperative PRMT5 inhibitor, in MTAP-deleted NSCLC. J Thorac Oncol. 2024;19(10 Suppl):S350-S351.
