World's first participant recruited to vital lung cancer trial led in the East of England

The Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) has become the first site in the world to recruit patients to a clinical trial looking at developing a breath test for earlier diagnosis of lung cancer.

Trevor, 70, from Norwich, is the first patient to take part in the Phase 2 trial being led by CRN East of England and funded by Owlstone Medical (Owlstone). He was recruited by Professor Eleanor Mishra and team at the NIHR Norfolk Clinical Research Facility, hosted by NNUH.

Trevor will take part in the study which could help identify patients with lung cancer at a much earlier stage to increase the chances of curative therapies. This includes the identification of lung cancer in patients without symptoms and in those who have abnormal findings on radiological imaging such as CT scans.

Phase 2 of the EVOLUTION trial will assess the diagnostic performance of a probe for detection of lung cancer. In addition to acting as a screening tool for the early detection of lung cancer, there is potential for the test to be used to differentiate between benign and malignant lung nodules.

The study has also been designed to allow differentiation between individuals with lung cancer and relevant contrast groups such as patients with Chronic Obstructive Pulmonary Disease (COPD). Phase 1 of the EVOLUTION study successfully achieved key safety and proof of concept milestones.

Trevor attended the NIHR Norfolk Clinical Research Facility, based at the Quadram Institute in Norwich, on 5 October 2023. He said: “I had pneumonia at Christmas and ended up having a CT scan which showed something on my lung. Luckily, I’ve been given the all-clear, and they asked if I’d be interested in taking part in this research. I was more than happy because you never know, it might help someone else.”

Prof Mishra, Respiratory Consultant and Principal Investigator, said: “Lung cancer has the highest death rate for any cancer in the UK. The earlier we catch lung cancer, the more likely we are to be able to cure people. This study has the potential to enable much earlier lung cancer diagnosis, and therefore save many lives.”

Billy Boyle, co-founder and CEO at Owlstone Medical, the company behind the breath biopsy technology, said: “With the recruitment of the first patients into Phase 2, we are excited to continue to progress a test that has the potential to transform lung cancer diagnosis by substantially increasing the uptake of testing, leading to more cases of lung cancer being caught early and significantly reducing mortality and costs. Our nodule management test also holds the potential for more effective identification of benign nodules, reducing unnecessary biopsies and surgery.”

Dr Helen Macdonald, CRN East of England Chief Operating Officer, said: “We are immensely grateful to patients like Trevor who generously give their time and efforts to help our research community find better ways to care for people. We also thank Prof Mishra and her team who work tirelessly to find the evidence base needed to improve such vital diagnostics and treatments.”

In total up to 350 people will take part in the study across three sites in Europe and six sites in the UK. Sites in the UK, including NNUH and Royal Papworth Hospital, Cambridge, are supported in delivering this study by NIHR.