Reduced frequency of pembrolizumab treatment for advanced lung cancer
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
Run by Imperial College London · NCT05085028 · Data updated 2026-11-12
This study is testing if giving pembrolizumab treatment for advanced lung cancer less often can still work well while making life easier for patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1750 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 37 sites (Bournemouth and 36 other locations) |
| Status | Recruiting |
| Started | June 23, 2022 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | March 7, 2024 |
| Trial ID | NCT05085028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have received 6 months of pembrolizumab treatment for advanced NSCLC and are planned to continue therapy due to ongoing benefits.
✕Probably not a fit
Patients who have experienced disease progression or are not tolerating treatment at the 6-month mark will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the safety and effectiveness of reducing the frequency of pembrolizumab treatment in patients with advanced non-small cell lung cancer (NSCLC) who have been progression-free after 6 months of standard therapy. Participants will be randomized to receive either the standard 6-week treatment or a reduced frequency of 12 weeks, with further arms testing 9, 15, and 18 weeks if initial results are promising. The goal is to determine if less frequent dosing can maintain efficacy while reducing treatment burden and costs. The study aims to enhance patient quality of life by minimizing hospital visits and potential side effects associated with more frequent treatments.
Why it matters
Potential benefit: If successful, this approach could lead to significant cost savings and improved quality of life for patients undergoing treatment for advanced lung cancer.
How similar studies have gone: While this approach is innovative, previous studies have indicated that reduced dosing schedules may be effective, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
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Royal Bournemouth Hospital
Bournemouth, United Kingdom Recruiting -
Royal Sussex County Hospital
Brighton, United Kingdom Recruiting -
Bristol Haematology and Oncology Centre
Bristol, United Kingdom Recruiting -
Queen's Hospital
Burton-on-Trent, United Kingdom Recruiting -
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom Recruiting -
Velindre Cancer Centre
Cardiff, United Kingdom Recruiting
Show 31 more locations
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Colchester Hospital
Colchester, United Kingdom Recruiting -
Royal Derby Hospital
Derby, United Kingdom Recruiting -
NHS Lothian
Edinburgh, United Kingdom Recruiting -
Royal Devon and Exeter Hospital
Exeter, United Kingdom Recruiting -
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom Recruiting -
New Victoria Hospital
Glasgow, United Kingdom Recruiting -
Calderdale & Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom Recruiting -
Ipswich Hospital
Ipswich, United Kingdom Recruiting -
Kettering General Hospital
Kettering, United Kingdom Recruiting -
Forth Valley Royal Hospital
Larbert, United Kingdom Recruiting -
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom Recruiting -
Leicester Royal Infirmary
Leicester, United Kingdom Recruiting -
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom Recruiting -
Guys Hospital
London, United Kingdom Recruiting -
Imperial College Healthcare NHS Trust
London, United Kingdom Recruiting -
North Middlesex University Hospital NHS Trust
London, United Kingdom Recruiting -
The Christie NHS Foundation Trust
Manchester, United Kingdom Recruiting -
Northampton General Hospital NHS Trust
Northampton, United Kingdom Recruiting -
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom Recruiting -
Peterborough City Hospital
Peterborough, United Kingdom Recruiting -
Poole Hospital
Poole, United Kingdom Recruiting -
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom Recruiting -
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom Recruiting -
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom Recruiting -
Royal Cornwall Hospital
Truro, United Kingdom Recruiting -
Worthing Hospital
Worthing, United Kingdom Recruiting -
Yeovil Hospital
Yeovil, United Kingdom Recruiting -
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom Not yet recruiting -
Royal Surrey NHS Foundation Trust
Guildford, United Kingdom Not yet recruiting -
NHS Fife
Kirkcaldy, United Kingdom Not yet recruiting -
St Bartholomew's Hospital
London, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Michael Seckl — Imperial College London
- Study coordinator: Alex Baker
- Email: a.williams@imperial.ac.uk
- Phone: 020 7594 2180
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.