At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab 25 MG/ML [Keytruda] (drug)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- Pembrolizumab 25 MG/ML [Keytruda] — drug: Pembrolizumab to be given at 400mg intravenous over 5 different frequencies
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at adults with advanced non-small cell lung cancer (NSCLC) who have already had 6 months of a immunotherapy drug called pembrolizumab, with or without chemotherapy, and are still benefiting from it. It is testing whether giving pembrolizumab less often works as well as the usual schedule. It is a Phase III trial, run by Imperial College London.
Who can take part
- Adults aged 18 or over
- Have had 6 months of pembrolizumab treatment, with or without chemotherapy, for advanced non-small cell lung cancer
- Doctors plan to carry on with immunotherapy because the treatment is still working
- Able and willing to give written consent and follow the study schedule
Who may not be able to
- The cancer has got worse, or the treatment is not being tolerated, at the 6-month point
- Doctors do not plan to carry on with immunotherapy
- Having another cancer at the same time, including a new cancer diagnosis or a previously treated cancer coming back since starting pembrolizumab
- Currently taking part in another study of an experimental drug or device, or have done so within 28 days of joining this study
What taking part involves
- • Pembrolizumab immunotherapy given less often than usual (this is what the study is testing)
- • You will be put into one of two groups by chance (randomised) — this is an open-label study, meaning you and your doctors will know which group you are in
Time commitment: Not stated — ask the trial team about how many visits are needed and how long the study lasts.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,750
- Started
- 2022-06-23
- Last checked
- 2024-03
Plain English Summary
What is this study?
- • Testing a new treatment for lung cancer, nonsmall cell
- • Phase3 - 1,750 participants
- • REFINE-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with lung cancer, nonsmall cell
Where?
- • Bournemouth - Royal Bournemouth Hospital
- • Brighton - Royal Sussex County Hospital
- • Bristol - Bristol Haematology and Oncology Centre
- • Burton-on-Trent - Queen's Hospital
- • +33 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
REFINE-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective. Patients treated with 1st line pembrolizumab who are progression free and otherwise planning to continue therapy at 6 months will be initially randomised to control 6 weekly versus interventional 12 weekly therapy. If an interim analysis shows that the 12 weekly treatment is no less effective, subsequent patients will also be randomised to 9, 15 and 18 weekly treatment frequency arms. Patients who progress on a reduced frequency arm will be offered re-escalation to standard 6 weekly therapy.
More detail
Immunotherapy with pembrolizumab targeting the T cell inhibitory PD-1 receptor has significantly improved outcomes in advanced non-small cell lung cancer (NSCLC). Approximately 3600 new patients are treated in the 1st line setting per year in England alone and up to 25% remain on 6 weekly pembrolizumab for 2 years. However, pharmacological and clinical trial data suggest current frequent dosing for 2 years result in overtreatment. Indeed, pembrolizumab remains bound to its target receptor for up to 100 days following a single dose and studies in multiple tumour types have found no relationship between dose and patient outcome. Moreover, anti-PD1 treated patients who respond but discontinue therapy either as planned after 2 years, or earlier because of toxicity, can either remain in remission and/or be sensitive to re-challenge with pembrolizumab. REFINE-lung will test whether reduced pembrolizumab dose frequency (9, 12, 15, 18 weeks) after 6 months of standard treatment is safe and effective. This UK study represents a unique opportunity to determine whether pembrolizumab dose frequency can be safely reduced in NSCLC, resulting in significant cost benefits to the NHS and globally, in addition to enhanced patient QoL associated with fewer hospital attendances and reduced toxicity.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Written agreement to take part prior to initiation of any study procedures and willingness and ability to comply with the...
Who cannot take part
- ✗Disease progression or not tolerating treatment at 6 months into therapy
- ✗Clinician does not intend to continue treatment that helps your immune system fight cancer
- ✗Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously...
See the full criteria
Where Is This Study? (37 UK sites)
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Queen's Hospital
Burton-on-Trent, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Colchester Hospital
Colchester, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
New Victoria Hospital
Glasgow, United Kingdom
Royal Surrey NHS Foundation Trust
Guildford, United Kingdom
Calderdale & Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
NHS Fife
Kirkcaldy, United Kingdom
Forth Valley Royal Hospital
Larbert, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Guys Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
North Middlesex University Hospital NHS Trust
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Northampton General Hospital NHS Trust
Northampton, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom
Poole Hospital
Poole, United Kingdom
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Worthing Hospital
Worthing, United Kingdom
Yeovil Hospital
Yeovil, United Kingdom
How to Get in Touch
Alex Baker
Sponsor contactCONTACT
Philip Badman
Sponsor contactCONTACT