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)
Recruiting now · Phase 3
Conditions studied: Lung Cancer, Nonsmall Cell
In brief
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.
Key facts
- Study ID
- NCT05085028
- Run by
- Imperial College London
- People needed
- 1750
- Starts
- 2022-06-23
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2024-03-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule
- Any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced Non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit.
You may not qualify if…
- Disease progression or not tolerating treatment at 6 months into therapy
- Clinician does not intend to continue immunotherapy
- Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment.
- Any patient currently receiving an investigational agent and/or using an investigational device or has participated in a study of an investigational agent and/or used an investigational device within 28 days of randomisation.
Where it is running
- Yeovil Hospital — Yeovil, United Kingdom (enrolling)
- Royal Sussex County Hospital — Brighton, United Kingdom (enrolling)
- Bristol Haematology and Oncology Centre — Bristol, United Kingdom (enrolling)
- Queen's Hospital — Burton-on-Trent, United Kingdom (enrolling)
- The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom (enrolling)
- Royal Cornwall Hospital — Truro, United Kingdom (enrolling)
- Worthing Hospital — Worthing, United Kingdom (enrolling)
- Royal Bournemouth Hospital — Bournemouth, United Kingdom (enrolling)
- East Kent Hospitals University NHS Foundation Trust — Canterbury, United Kingdom (enrolling)
- Velindre Cancer Centre — Cardiff, United Kingdom (enrolling)
- Colchester Hospital — Colchester, United Kingdom (enrolling)
- Royal Derby Hospital — Derby, United Kingdom (enrolling)
- NHS Lothian — Edinburgh, United Kingdom (enrolling)
- Royal Devon and Exeter Hospital — Exeter, United Kingdom (enrolling)
- Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom (enrolling)
- New Victoria Hospital — Glasgow, United Kingdom (enrolling)
- Calderdale & Huddersfield NHS Foundation Trust — Huddersfield, United Kingdom (enrolling)
- Ipswich Hospital — Ipswich, United Kingdom (enrolling)
- Kettering General Hospital — Kettering, United Kingdom (enrolling)
- Forth Valley Royal Hospital — Larbert, United Kingdom (enrolling)
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
- Leicester Royal Infirmary — Leicester, United Kingdom (enrolling)
- The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom (enrolling)
- Guys Hospital — London, United Kingdom (enrolling)
- Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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