A pioneering clinical trial funded through charitable donations is testing a novel approach to enhance immunotherapy effectiveness by combining it with an anti-inflammatory medication for patients with advanced cancers. The LION trial (Lifting Immune Checkpoints with NSAIDs) represents a significant step forward in the fight against some of the most challenging cancer types.
Novel Approach to Enhance Immunotherapy
The trial focuses on combining celecoxib, a non-steroidal anti-inflammatory drug (NSAID), with standard immunotherapy treatments. This approach targets three specific cancer types: triple-negative breast cancer, non-small cell lung cancer, and renal cell carcinoma. The strategy aims to overcome one of immunotherapy's main limitations - its inconsistent response rates among patients.
Dr. Anne Armstrong, consultant medical oncologist at The Christie NHS Foundation Trust and trial lead, explains: "Based on our preclinical research and that of others, we believe that the addition of celecoxib to standard immune checkpoint blockade treatments will reduce tumour-promoting inflammation and immune-suppression at the tumour, resulting in a more effective immune response."
Trial Design and Implementation
The LION trial has already begun recruiting patients, with 11 participants enrolled thus far. The study aims to include 89 patients newly diagnosed with advanced forms of lung, breast, and renal cancers. Participants receive their standard NHS-approved cancer treatments alongside celecoxib, with regular monitoring through scans and blood sample analysis at the CRUK Manchester Institute and CRUK National Biomarker Centre.
The trial represents a unique collaboration across multiple institutions, with six participating sites including Royal Cornwall Hospital, The Royal United Hospital Bath NHS Foundation Trust, and Weston Park Hospital. Additional sites include Glan Clwyd Hospital and Wrexham Maelor Hospital under the Betsi Cadwaladr University Health Board.
Patient Perspective and Real-World Impact
Annie Fields, a 32-year-old GP from Chorlton, Manchester, offers insight into the patient experience as a trial participant. Diagnosed with triple negative metastatic breast cancer in 2021, Fields joined the LION trial after experiencing a recurrence. She shares, "Celecoxib is a small capsule to take, and if it improves my body's immune response and helps the immunotherapy fight this cancer then I'm all for it."
Research Implications and Future Outlook
Dr. Armstrong highlights the trial's unique approach: "The LION trial marks the first time these three cancer types have been studied together under one trial. Bringing together specialists in breast, lung, and renal cancers allows us to create a unique research platform, one that will guide future studies into multi-tumour treatments."
The Christie Charity has demonstrated its commitment to advancing cancer research by pledging £30m over the next five years. Louise Hadley, chief executive of The Christie Charity, emphasizes their dedication: "We are committed to investing in groundbreaking research that has the potential to revolutionise treatment for some of the most aggressive cancers."
Recruitment for the LION trial is expected to continue until April 2026, marking a significant step toward understanding how anti-inflammatory medications might enhance the effectiveness of immunotherapy in treating advanced cancers.
