Clinical trial Recruiting at 33 sites Phase 3 Interventional Ages 18 and up

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.

More Lung Cancer, Nonsmall Cell trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1750 (estimated)
SponsorImperial College London
Academic / other
Drugs / interventionspembrolizumab, chemotherapy, immunotherapy
Locations37 sites (Bournemouth and 36 other locations)
StatusRecruiting
StartedJune 23, 2022
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedMarch 7, 2024
Trial IDNCT05085028 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.