Pragmatica-Lung Cancer Treatment Trial
What is the Pragmatica-Lung cancer trial?
Pragmatica-Lung is a phase 3 clinical trial for people with non-small cell lung cancer that has spread beyond the lungs (stage 4 cancer). People in the trial will be assigned by chance (randomly) to receive either standard chemotherapy or a combination of the drugs ramucirumab (Cyramza) and pembrolizumab (Keytruda). These drugs have already been approved by the Food and Drug Administration (FDA) to treat certain types of cancer, including some types of lung cancer. Ramucirumab is a targeted drug that works by preventing new blood vessels from growing, and pembrolizumab is an immunotherapy that helps the body’s immune system attack the cancer.
Who is eligible to participate?
People aged 18 or older with stage 4 non-small cell lung cancer whose cancer has continued growing after treatment with immunotherapy and chemotherapy may be eligible to participate. Researchers hope to enroll 700 people to the trial.
What are the goals of Pragmatica-Lung?
The goal of the Pragmatica-Lung trial is to see if this combination of drugs can help those with advanced lung cancer live longer than with standard chemotherapy.
The combination of ramucirumab and pembrolizumab that is being studied in Pragmatica-Lung was tested in an earlier phase 2 clinical trial that was part of the Lung-MAP precision medicine trial. In that trial, the combination seemed to help certain people with stage 4 lung cancer live longer. Pragmatica-Lung will enroll more and a wider variety of participants than the previous trial to confirm if the combination of pembrolizumab and ramucirumab helps patients live longer than if they were on standard chemotherapy.
Why is the Pragmatica-Lung clinical trial important?
Pragmatica-Lung is designed to remove many of the barriers that prevent people from joining clinical trials. Many trials restrict who can join based on how well they can perform the functions of daily life, a measure called performance status. Pragmatica-Lung allows the participation of people with lower performance status, who are more representative of people with advanced lung cancer.
The trial designers also cut out many of the extra tests, data collections, and secondary study goals that are often included in clinical trials. Although researchers can learn a lot from these other tests and side studies, they tend to place a large burden on study doctors, as well as on patients. Because ramucirumab and pembrolizumab are already FDA approved for many cancer indications, their side effects are well known. Therefore, the only side effects data trial investigators will collect is information on severe side effects from the two-drug combination.
Who is sponsoring the Pragmatica-Lung study?
Pragmatica-Lung is sponsored by the National Cancer Institute and being led by the SWOG Cancer Research Network in collaboration with the Alliance for Clinical Trials in Oncology. The study will be conducted with participation of the four US NCI National Clinical Trials Network (NCTN) groups that focus on cancer in adults. Pharmaceutical companies Merck and Eli Lilly and Co. are each providing one of the study drugs and additional trial funding.
This trial is part of a broader effort by NCI and FDA to modernize clinical trials. The hope is that this type of simplified trial can be less burdensome to patients and investigators and serve as a model for future cancer clinical trials.
How can I learn more about Pragmatica-Lung?
People interested in learning more about the Pragmatica-Lung trial should speak with their doctor. They may also view the protocol abstract to see detailed eligibility criteria, participating locations, and study outline, which they can share with their health care team.
The Pragmatica-Lung trial is indexed on Clinical Trials.gov under the identifier NCT05633602 and is also identified by the study number SWOG-S2302.