It’s positive that a new cancer trial is about to start in the US, but it’s not out of the ordinary, right? This trial is one of the first to be conducted in a real-world clinical setting and will serve as a new model for future clinical trials.
The National Cancer Institute (NCI) helped launch the Pragmatica-Lung Study, a Phase 3 clinical trial investigating the use of two-drug therapy for patients with advanced (stage 4) non-small cell lung cancer (NSCLC) . What makes this exam different is that it was one of the first to take a “hands-on” approach.
Practical clinical trials (PCTs) are designed to evaluate the efficacy of therapeutic interventions in real-world clinical situations, whereas descriptive trials are designed to test whether interventions work under ideal conditions. test. The way PCT is performed yields results that can be generalized and applied to everyday settings.
Randomized controlled trials (RCTs), which are more common and tend to be more descriptive than pragmatic, are the gold standard for researching therapeutic and preventive interventions, but are costly. A 2018 review of the costs of RCTs found that the estimated total costs of RCTs ranged from US$43,000 to US$103,254 per patient.
The National Institutes of Health (NIH), of which NCI participates, and the FDA are working together to use the PCT model to remove many barriers to human participation and modernize clinical trials.
“This study is designed to eliminate potential barriers to enrollment and provides a model for increasing diversity and enrollment in clinical trials,” said NCI Director Monica Bertagnoli. rice field.
Because PCT is performed in a healthcare setting such as a hospital, nursing home, clinic, or doctor’s office, it produces rigorous, clinically applicable evidence to guide healthcare decision makers. Importantly, despite the relaxed registration criteria, the PCT remains committed to the safety of its participants.
James Doroshow, director of NCI’s Division of Cancer Treatment and Diagnostics, said:
The Pragmatica-Lung Study enrolled up to 700 participants and demonstrated that the combination of two FDA-approved drugs, ramucirumab (Cyramza) and pembrolizumab (Keytruda), became the standard of care for patients with advanced NSCLC who had failed prior chemotherapy and immunotherapy to assess whether it improves overall survival over conservative chemotherapy. .
Ramucirumab is a targeted therapy drug called a monoclonal antibody developed to treat solid tumors. It prevents the growth of new blood vessels that are necessary for tumor growth. Pembrolizumab is a type of immunotherapy that stimulates the body’s immune system to fight cancer cells.
By taking a pragmatic approach in the Pragmatica-Lung study, researchers hope to see promising results from the first NCI-sponsored lung cancer precision medicine trial, a randomized Phase 2 clinical trial. increase.
“With significant public-private partnerships, Pragmatica-Lung reflects the innovative approach NCI is taking to meet its Cancer Moonshot goals, which include reducing cancer mortality within the next 25 years. This includes reducing the cost by 50%,” said Bertagnolli.
Source: National Cancer Institute
