Pragmatic lung study a streamlined model For Future cancer Clinical Trials commences enrolling pateints

As a component of the National Institutes of Health (NIH), the National Cancer Institute (NCI) has assisted in the beginning of a phase 3 randomised clinical trial (NCT05633602) evaluating a two-drug combination for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The Pragmatica-Lung Study (also known as S2302) is one of the first clinical trials supported by the NCI to employ a trial design that eliminates many of the obstacles that hinder people from participating in clinical trials.

This "pragmatic" strategy tries to make clinical trials more accessible. The research is a component of NIH and the US Food and Drug Administration's (FDA) larger initiative to modernise clinical trials. Clinical studies conducted pragmatically still guarantee patient safety while having fewer and easier eligibility requirements than trials conducted conventionally. It is hoped that this kind of streamlined trial will be less demanding on participants and researchers, enrol people more quickly, be more reflective of the real-world patient population, and act as a template for additional cancer clinical studies.

“This study is designed to eliminate potential barriers to enrollment and provides a model for increasing diversity and enrollment in clinical trials,” said Monica M. Bertagnolli, M.D., director of NCI. “Pragmatica-Lung, with its critical public and private partnerships, reflects the innovative approaches NCI is taking to achieve the Cancer Moonshot? goals, including reducing the cancer death rate by 50% within the next 25 years.” The trial will look at whether combining two FDA-approved drugs, pembrolizumab (Keytruda, made by Merck), and ramucirumab (Cyramza, made by Eli Lilly and Company), improves overall survival (how long people live) in patients with advanced NSCLC whose disease has advanced after receiving prior immunotherapy and chemotherapy.

“These trials will make it easier for physicians who do not work in big academic medical centres to enroll their patients, resulting in participation by more diverse populations,” said James H. Doroshow, M.D., director of NCI’s Division of Cancer Treatment and Diagnosis. “Making trials more accessible, while upholding rigorous scientific and safety standards, means that more health care practitioners and patients will have an opportunity to participate.”

Up to 700 people from all throughout the United States will participate in the experiment. Immune checkpoint inhibitors (a kind of immunotherapy) and chemotherapy were previously used to treat adults 18 years of age and older with stage 4 or recurrent NSCLC. Patients will be randomly randomised to receive either ramucirumab plus pembrolizumab or standard care. The trial, which is anticipated to finish recruitment by the end of 2025, will focus mostly on how long patients in the two groups live.