Lung Cancer Trial Has Broader Eligibility Criteria, Overcomes Barriers

Researchers hope that the Pragmatica-Lung trial will help more patients become eligible for clinical trials and improve lung cancer outcomes.

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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.

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“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,” said Dr. James H. Doroshow, director of NCI’s division of cancer treatment and diagnosis, said in the release. “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.”

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.

Study authors are hoping to confirm results from the previously conducted phase 2 S1800A trial — also known as Lung-MAP — that found, in a population of 136 patients, that Cyramza plus Keytruda led to better outcomes. According to data presented at the 2022 American Society of Clinical Oncology annual meeting, the average overall survival for Cyramza plus Keytruda was 14.5 months, compared with 11.6 months with the current standard-of-care therapies.

Cyramza and Keytruda are both within a class of drugs called monoclonal antibodies, though they work in different ways. Cyramza — which is approved as a single-agent for liver cancer treatment — blocks the growth of new blood vessels that cancer cells need to grow. Meanwhile, Keytruda works by inhibiting a protein that helps cancer cells hide from the immune system, thereby allowing the immune system to find and fight the cancer.

Members of the NCI are also hoping that this trial will work toward the Cancer Moonshot goal of cutting the cancer-related death rate in half in coming years.

“This study is designed to eliminate potential barriers to enrollment and provides a model for increasing diversity and enrollment in clinical trials,” said Dr. Monica M. Bertagnolli, director of the 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.”

Patients who are interested in participating in Pragmatica-Lung can discuss their eligibility with their health care teams, as the trial is currently active. Researchers plan on completing enrollment by the end of 2025.

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