Actively Recruiting
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)
Led by Imperial College London · Updated on 2024-03-07
1750
Participants Needed
37
Research Sites
257 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
N
National Institute for Health Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and willingness to follow the study schedule
- Age 18 years or older
- Received 6 months of pembrolizumab treatment with or without chemotherapy for advanced non-small cell lung cancer
- Planned to continue immunotherapy treatment because of continued benefit
You will not qualify if you...
- Disease progression or intolerance to treatment at 6 months
- Clinician does not plan to continue immunotherapy
- Diagnosis of any new or recurrent cancer since starting pembrolizumab
- Currently receiving or recently participated in a study involving an investigational drug or device within 28 days of randomisation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Actively Recruiting
2
Royal Sussex County Hospital
Brighton, United Kingdom
Actively Recruiting
3
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Actively Recruiting
4
Queen's Hospital
Burton-on-Trent, United Kingdom
Actively Recruiting
5
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Not Yet Recruiting
6
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Actively Recruiting
7
Velindre Cancer Centre
Cardiff, United Kingdom
Actively Recruiting
8
Colchester Hospital
Colchester, United Kingdom
Actively Recruiting
9
Royal Derby Hospital
Derby, United Kingdom
Actively Recruiting
10
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
11
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
12
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
13
New Victoria Hospital
Glasgow, United Kingdom
Actively Recruiting
14
Royal Surrey NHS Foundation Trust
Guildford, United Kingdom
Not Yet Recruiting
15
Calderdale & Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom
Actively Recruiting
16
Ipswich Hospital
Ipswich, United Kingdom
Actively Recruiting
17
Kettering General Hospital
Kettering, United Kingdom
Actively Recruiting
18
NHS Fife
Kirkcaldy, United Kingdom
Not Yet Recruiting
19
Forth Valley Royal Hospital
Larbert, United Kingdom
Actively Recruiting
20
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
21
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
22
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
23
Guys Hospital
London, United Kingdom
Actively Recruiting
24
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
25
North Middlesex University Hospital NHS Trust
London, United Kingdom
Actively Recruiting
26
St Bartholomew's Hospital
London, United Kingdom
Not Yet Recruiting
27
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
28
Northampton General Hospital NHS Trust
Northampton, United Kingdom
Actively Recruiting
29
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Actively Recruiting
30
Peterborough City Hospital
Peterborough, United Kingdom
Actively Recruiting
31
Poole Hospital
Poole, United Kingdom
Actively Recruiting
32
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
Actively Recruiting
33
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Actively Recruiting
34
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
35
Royal Cornwall Hospital
Truro, United Kingdom
Actively Recruiting
36
Worthing Hospital
Worthing, United Kingdom
Actively Recruiting
37
Yeovil Hospital
Yeovil, United Kingdom
Actively Recruiting
Research Team
A
Alex Baker
CONTACT
P
Philip Badman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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