The phase 3 Pragmatica-Lung study has broader eligibility criteria than many other trials, expanding access to more patients and clinicians.
Lung Cancer Trial Has Broader Eligibility Criteria, Overcomes Barriers
The National Cancer Institute (NCI) launched the phase 3 Pragmatica-Lung Study (S2302) clinical trial evaluating Cyramza (ramucirumab) plus Keytruda (pembrolizumab) for patients with stage 3 or recurrent non-small cell lung cancer, according to a press release from the agency.
The Pragmatica study got its name due to the “pragmatic” approach to remove barriers to patient participation in clinical trials, according to the NCI, which is a part of the National Institutes of Health.
Pragmatica-Lung and other similar trials have fewer and simpler eligibility criteria than other trials, which often have large groups of patients who are unable to participate due to stringent criteria around factors such as age, health status and the presence of other conditions. These broader criteria will make trials more available to both patients and health care providers.
“These trials will make it easier for physicians who do not work in big academic medical centers to enroll their patients, resulting in participation by more diverse populations. 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.”
– Dr. James H. Doroshow, director of NCI’s division of cancer treatment and diagnosis
Researchers are planning on enrolling up to 700 adults with stage 4 or recurrent non-small cell lung cancer who were previously treated with an immune checkpoint inhibitor and chemotherapy. Participants will be randomly assigned to one of two treatment groups: Cyramza plus Keytruda or standard chemotherapy.
The main goal of the trial is to see if the two-drug combination improves overall survival (time from treatment until death of any cause) over the current standard of care.