OU Faculty Member Co-Leading Innovative National Trial to Advance Lung Cancer Treatment

College of Medicine, is the national co-leader of the PROSPECT-Lung clinical trial that will evaluate the timing of immunotherapy for patients with operable non-small cell lung cancer.

The trial is the first from the National Cancer Institute’s Clinical Trials Innovation Unit (CTIU), which was formed to accelerate the development of studies and to generate findings more applicable to the real-world population.

Lung cancer is the most common cause of cancer-related deaths in both women and men, making up about 20% of all cancer deaths. Non-small cell lung cancer accounts for 80-85% of cases, compared with small cell lung cancer. The burden is especially high in Oklahoma. According to the American Lung Association’s 2024 “State of Lung Cancer” report, Oklahoma ranks 47^th in the nation for survival rates and 50^th in the nation for lung cancer screening.

For many years, early-stage lung cancer was treated with surgery followed by chemotherapy, which reduced the possibility of the cancer returning by about 5%. Over the past few years, research has demonstrated that adding immunotherapy to the chemotherapy regimen reduced the chances of cancer recurrence by about 40%. The immunotherapy-chemotherapy regimen has been administered to patients both before and after surgery, but the medical community does not yet know which approach results in better health outcomes and is better tolerated by patients. The PROSPECT-Lung trial aims to fill that gap in knowledge.

Trial participants will be randomly assigned to two treatment plans, both of which have proved beneficial to patients. In one group, they will receive chemotherapy and immunotherapy, followed by surgery to remove the tumor and up to a year more of immunotherapy. In the other group, patients will have surgery first, followed by chemotherapy and up to a year of immunotherapy.

“From previous large studies, we know these treatments work, but this trial will allow us to compare the two approaches. We want to see which approach is better for helping patients live longer without a return of cancer and without severe complications from treatment,” said Aljumaily, a hematologist-oncologist at OU Health Stephenson Cancer Center.

Three types of immunotherapy, all approved by the U.S. Food and Drug Association, will be part of the treatment protocol. Immunotherapy drugs have revolutionized the treatment of many cancers over the past decade, including lung cancer, because they help the body’s immune system recognize and kill cancer cells. Oncology clinical trials worldwide have incorporated immunotherapy medications, Aljumaily said, and they will likely advance cancer care for years to come.

As the first to open through the Clinical Trials Innovation Unit, the trial marks a significant step toward more pragmatic studies that yield evidence faster. Traditionally, clinical trial development is lengthy, inclusion and exclusion criteria are strict, and the process can be cumbersome. Studies like PROSPECT-Lung suit a streamlined approach because the treatments’ safety and effectiveness are already known.

“The trial is unique because it is designed to reflect real-world treatment decisions,” Aljumaily said. “We can generate evidence that is both scientifically rigorous and highly applicable to clinical practice.”

The PROSPECT-Lung trial will enroll 1,100 patients at numerous sites across the United States, including OU Health Stephenson Cancer Center. Aljumaily is the principal investigator and developed the trial for the SWOG Cancer Research Network, which is partnering with the Alliance for Clinical Trials in Oncology to lead the trial. Daniel Morgensztern, M.D., professor in the Division of Medical Oncology at Washington University, Siteman Cancer Center, is the principal investigator for Alliance. The trial is conducted within the NCI’s National Clinical Trials Network, funded by the National Institutes of Health, with participation from the NCI Community Oncology Research Program.

“PROSPECT-Lung may pave the way toward a future where clinical trials reduce the burden of participation for patients and investigators through real-world, pragmatic designs,” said Sheila Prindiville, M.D., MPH, director of the NCI Coordinating Center for Clinical Trials, part of the NIH. “PROSPECT-Lung is a critical component in NCI’s commitment to modernizing clinical trials.”

###

About the Project

For more information about the PROSPECT-Lung trial (also known as CTIU2317-A82304-S2402), please contact the NCI’s Cancer Information Service at 1-800-4-CANCER or visit the NCI website at https://clinicaltrials.gov/study/NCT06632327 for a list of sites that have the trial open, or learn more at clinicaltrials.gov (NCT06632327).