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Reduced frequency of pembrolizumab treatment for advanced lung cancer

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

Phase 3 Interventional Imperial College London · NCT05085028

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

PhasePhase 3
Study typeInterventional
Enrollment1750 (estimated)
Ages18 Years and up
SexAll
SponsorImperial College London Academic / other
Drugs / interventionspembrolizumab, chemotherapy, immunotherapy
Locations37 sites (Bournemouth and 36 other locations)
Trial IDNCT05085028 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While this approach is innovative, previous studies have indicated that reduced dosing schedules may be effective, suggesting potential for success in this trial.

Eligibility criteria

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 this trial is running

Bournemouth and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung Cancer, Nonsmall Cell
Last reviewed 2026-06-13 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.