The highly anticipated PROSPECT-Lung trial has officially opened, marking a significant step forward in the quest to improve treatment strategies for patients with resectable non-small cell lung cancer. The trial, which is the first to open through the newly formed National Cancer Institute (NCI) Clinical Trials Innovation Unit (CTIU), aims to evaluate the role of immunotherapy before and after surgery in patients with non-small cell lung cancer.
The PROSPECT-Lung trial is a large, multicenter trial developed and led by the Alliance for Clinical Trials in Oncology and the SWOG Cancer Research Network and conducted within the NIH-funded NCI National Clinical Trials Network (NCTN), It is designed to determine whether adding immune checkpoint inhibitors to standard chemotherapy, either before or after surgery, can help patients with resectable, early-stage non-small cell lung cancer live longer and stay cancer-free. The trial will also look at whether perioperative immunotherapy-;given both before and after surgery-;is more effective than just using it after surgery (adjuvant therapy).
Lung cancer is the most common cause of cancer-related deaths in both men and women, making up about 20% of all cancer deaths. It is mainly divided into two types: non-small cell lung cancer, which accounts for 80-85% of cases, and small cell lung cancer. It is often not detected until it is found during imaging tests for another health issue. Even when the cancer is caught early and treated with surgery and chemotherapy, most patients will eventually see the cancer return.
The PROSPECT-Lung trial is a critical milestone in our efforts to improve outcomes for patients with lung cancer. By testing the optimal timing of immunotherapy-;whether before or after surgery-;we hope to provide clearer guidance on how to integrate these new, powerful therapies into the treatment regimens for resectable lung cancer. This trial could have a major impact on how we treat patients and improve survival outcomes in this difficult-to-treat cancer."
Daniel Morgensztern, MD, Alliance Study Co-Chair and Professor in the Division of Medical Oncology at Washington University, Siteman Cancer Center
The trial builds on promising data from earlier studies showing that adding immune checkpoint inhibitors to chemotherapy may improve survival in patients with lung cancer when used in the neoadjuvant, adjuvant, or perioperative settings. However, a critical question remains: Should immune checkpoint inhibitors be given before or after surgical resection? The trial is structured to answer this question.
Raid Aljumaily, MD, SWOG Study Co-Chair and Associate Professor in the Division of Hematology/Oncology at the University of Oklahoma, OU Health Stephenson Cancer Center, emphasized the importance of the trial's design. "This trial is unique because it's designed to reflect real-world treatment decisions and will help define the optimal approach for integrating immunotherapy into standard care for resectable non-small cell lung cancer. By using a pragmatic trial design, we can generate evidence that is both scientifically rigorous and highly applicable to clinical practice."
The trial is part of the CTIU's broader mission to accelerate the development of innovative cancer treatments through collaboration, efficiency, and cutting-edge science. Launched in February 2023, the CTIU aims to advance high-priority clinical research needs. The hope is to put forth simplified trials with broadened eligibility criteria that will be less burdensome to patients and investigators and serve as models for future cancer clinical trials. PROSPECT-Lung is one of the first studies to benefit from the CTIU's commitment to improving the speed and efficacy of clinical trials.
"We are excited to see the PROSPECT-Lung trial get underway as one of the inaugural trials supported by the CTIU," said Michael LeBlanc, PhD, SWOG Group Statistician and Professor of Biostatistics at the Fred Hutchinson Cancer Center.
"This trial will employ an innovative pragmatic design with endpoints and data collection that align with the streamlining data collection initiative of NCI's Clinical Trials and Translational Research Advisory Committee (CTAC), and largely mirrors data collection in the electronic medical record," said Sumithra Mandrekar, PhD, Alliance Group Statistician and Professor of Biostatistics and Oncology at the Mayo Clinic. Of note, Dr. Mandrekar co-chaired the NCI-CTAC Streamlining Clinical Trials Working Group.
"PROSPECT-Lung is investigating a crucial unanswered question regarding the timing of immunotherapy and chemotherapy relative to surgery for stage II-III non-small cell lung cancer," said David Kozono, MD, PhD; Executive Officer of the Alliance Respiratory Committee and Associate Professor of Radiation Oncology at Dana-Farber/Harvard Cancer Center. "This is the type of question that is not necessarily addressed by pharma-sponsored research but is well-suited to the NCI-sponsored National Clinical Trials Network."
Anne Chiang, MD, PhD, Executive Officer of the SWOG Lung Committee and Associate Professor at Yale School of Medicine and Associate Yale Cancer Center Director, Clinical Initiatives, added that "this has been a unique collaborative effort co-led by Alliance and SWOG to answer the NCI call for innovative and pragmatic trials for lung cancer patients."
"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, MD, MPH, Director of the NCI Coordinating Center for Clinical Trials, part of the National Institute of Health. "PROSPECT-Lung is a critical component in NCI's commitment to modernizing clinical trials."
PROSPECT-Lung Patient Advocate Judy Johnson, MBA, shared her view on the possible impact of the trial. "This trial has the potential to answer a very important question for patients with non-small cell lung cancer who are candidates for surgery" she said. "Now, it isn't clear which of two usual treatment approaches may be more likely to keep their cancer from coming back or spreading, either receiving therapy before and after surgery, or receiving therapy only after surgery. [However,] it's critical to take the next important step to identify the most effective, least toxic, and optimum treatment approach for these patients."
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