A Phase 3 interventional study of Pembrolizumab 25 MG/ML [Keytruda] in Lung Cancer, Nonsmall Cell, sponsored by Imperial College London. Recruiting at 37 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Imperial College London · Phase 3, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 1,750 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 weekly pembrolizumab, 400mg intravenous
Drug: Pembrolizumab 25 MG/ML [Keytruda]
9 weekly pembrolizumab, 400mg intravenous
Drug: Pembrolizumab 25 MG/ML [Keytruda]
12 weekly pembrolizumab, 400mg intravenous
Drug: Pembrolizumab 25 MG/ML [Keytruda]
15 weekly pembrolizumab, 400mg intravenous
Drug: Pembrolizumab 25 MG/ML [Keytruda]
18 weekly pembrolizumab, 400mg intravenous
Drug: Pembrolizumab 25 MG/ML [Keytruda]
Pembrolizumab to be given at 400mg intravenous over 5 different frequencies
Overall survival at 2 years
Survival at 2 years, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination
Time frame: 18 months from randomisation
Overall survival from study entry
Survival, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination
Time frame: 2 years
Progression free survival
Progression free survival as assessed by RECIST v1.1, defined as time from study entry to first evidence of disease progression or death due to any cause
Time frame: 2 years
Overall response rate
Overall response rate (ORR) as assessed by RECIST v1.1, defined as complete response (CR) or partial response (PR)
Time frame: 2 years
Duration of response
Duration of response (DoR) as assessed by RECIST v1.1, defined as time from study entry to change in response from CR or PR to stable disease (SD) or progressive disease (PD)
Time frame: 2 years
Incidence of adverse events
Safety and tolerability as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years
Plan to share: No
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Imperial College London