October 2021

ComFluCOV Study Results

The ComFluCOV study looked in to what side effects, such as fever and tiredness, people get when they are given their second dose of the COVID-19 vaccine at the same time as the currently recommended flu vaccines. The study also looked at people’s immune responses to both vaccines when given together.

The ComFluCOV study has shown that there are no safety concerns when COVID-19 and flu vaccines are given at the same time. You can read a summary of the results here and the full publication at The Lancet.

Advanced lung cancer study now in set up

Lung cancer is the most common cause of cancer death worldwide, and the majority of patients in the UK present with advanced disease. Although these new therapies are very good, residual advanced lung cancer persists in most patients after treatment and management of this is variable across the UK. Some patients receive only palliative care, while others may receive more aggressive treatment in the form of surgery, radiotherapy and/or ablation to remove all remaining cancer within the lung and throughout the body. Collectively, these more aggressive treatments are known as ‘local consolidative treatment’ (LCT). LCT is intensive, impacts quality of life and is expensive but, most importantly, we do not know whether it results in a better outcome for patients.

The aim of the RAMON study is to find out whether LCT is worthwhile (or not) for patients with residual advanced lung cancer. RAMON is a pragmatic, multi-centre, parallel group, randomised controlled trial that will run , with the primary outcome for the study being overall survival (minimum follow-up 2 years after randomisation). The set-up phase of the RAMON study began in August 2021 and we aim to recruit 244 patients over 3 years. We hope to recruit our first patient in April 2022!

You can read more on the RAMON study page.

This study is funded by the NIHR Health Technology Assessment Programme The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Study Manager: Chloe Beard

ASTUTE Study Open to Recruitment

Autoimmune uveitis is a rare eye disease where the body’s own immune system causes sight-threatening damage to the retina at the back of the eye. The disease is usually treated with steroids, which are often not tolerated well, and long-term use can have side effects. Adalimumab is a new drug that targets chemicals released by inflamed tissue, limiting their damage to the body. Recent studies suggest adalimumab is an effective way to treat uveitis in some patients.

The ASTUTE trial will identify which patients are most likely to benefit from adalimumab. All trial participants will be given adalimumab for 4 months. Participants who are successfully treated with adalimumab, without the need for high dose steroids, will then either continue adalimumab or switch to a placebo “dummy” treatment. Neither the patient nor their doctor will know which they are receiving. This will allow the trial to find out whether adalimumab is better at preventing recurrence of uveitis than placebo, and whether it is cost-effective. Participants will be followed up for up to 36 months and regular eye examinations, tests and questionnaires will be used to assess how well participants are doing. If a participants condition gets worse during follow-up, they will have the opportunity to restart the trial and switch to the other treatment allocation; this ensures that participants will be able to access adalimumab should they need it.

The trial opened to recruitment in July 2021, with the aim to open 20 sites across England. The recruitment target is 400 patients over 18 months, and the first patients joined the trial in August 2021.

This project is funded by the NIHR-HTA programme (16/24/09). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Study coordinator: Robin Wickens

Twitter: @AstuteTrial