The PROSPECT-Lung trial, a large, multi-center initiative, has commenced to determine the optimal timing of immunotherapy for patients with resectable non-small cell lung cancer (NSCLC). This National Cancer Institute (NCI) Clinical Trials Innovation Unit (CTIU) study seeks to establish whether administering immune checkpoint inhibitors before or after surgery, in conjunction with standard chemotherapy, leads to improved survival rates and reduced cancer recurrence.
Addressing a Critical Question in Lung Cancer Treatment
For early-stage lung cancer, the standard approach has been surgery followed by chemotherapy, which reduces the risk of cancer recurrence by approximately 5%. Recent research indicates that adding immunotherapy to chemotherapy can further decrease recurrence by about 40%. However, it remains unclear whether administering this combined regimen before or after surgery yields better outcomes.
"The PROSPECT-Lung trial is a critical milestone in our efforts to improve outcomes for patients with lung cancer," said Daniel Morgensztern, MD, Alliance Study Co-Chair and Professor at Washington University, Siteman Cancer Center. "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."
Trial Design and Objectives
The PROSPECT-Lung trial will randomly assign 1,100 participants to one of two treatment arms. One group will receive chemotherapy and immunotherapy before surgery, followed by surgical tumor removal and up to a year of additional immunotherapy. The other group will undergo surgery first, followed by chemotherapy and up to a year of immunotherapy. The primary endpoint is to determine which approach results in longer patient survival without cancer recurrence and with fewer severe complications.
"This trial is unique because it is designed to reflect real-world treatment decisions," said Raid Aljumaily, MD, SWOG Study Co-Chair and Associate Professor at the University of Oklahoma, OU Health Stephenson Cancer Center. "We can generate evidence that is both scientifically rigorous and highly applicable to clinical practice."
Significance and Impact
Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for 80-85% of cases. Even with early detection and treatment involving surgery and chemotherapy, many patients experience cancer recurrence. The PROSPECT-Lung trial aims to refine treatment strategies by determining the most effective timing for incorporating immunotherapy.
The trial utilizes three FDA-approved immunotherapy drugs as part of the treatment protocol. These drugs enhance the body's immune system to recognize and eliminate cancer cells, marking a significant advancement in cancer care over the past decade.
Streamlined Approach and Collaboration
As the first trial launched through the CTIU, PROSPECT-Lung represents a move towards more pragmatic studies that yield faster evidence. The CTIU aims to accelerate the development of innovative cancer treatments through collaboration and efficiency. This trial's design reflects real-world treatment decisions, broadening eligibility criteria and reducing the burden on patients and investigators.
The PROSPECT-Lung trial is a collaborative effort between the Alliance for Clinical Trials in Oncology and the SWOG Cancer Research Network, conducted within the NCI's National Clinical Trials Network, and funded by the National Institutes of Health, with participation from the NCI Community Oncology Research Program.
