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A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Sponsor: Imperial College London
Summary
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.
Official title: A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Utilising a Novel Multi-arm Frequency-response Optimisation Design
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1750
Start Date
2022-06-23
Completion Date
2027-05-31
Last Updated
2024-03-07
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab 25 MG/ML [Keytruda]
Pembrolizumab to be given at 400mg intravenous over 5 different frequencies
Locations (37)
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, 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, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Worthing Hospital
Worthing, United Kingdom
Yeovil Hospital
Yeovil, United Kingdom