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Study identifier: NCT05085028 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: RecruitingREFINE-Lung

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)

Condition: Lung Cancer, Nonsmall Cell  ·  Sponsor: Imperial College London

PhasePhase 3
Planned participants1750
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where37 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Alex Baker  ·  020 7594 2180  ·  a.williams@imperial.ac.uk

Philip Badman  ·  philip.badman@imperial.ac.uk

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (37)

Royal Bournemouth HospitalBournemouth, United KingdomRecruiting
Royal Sussex County HospitalBrighton, United KingdomRecruiting
Bristol Haematology and Oncology CentreBristol, United KingdomRecruiting
Queen's HospitalBurton-on-Trent, United KingdomRecruiting
Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomNot Yet Recruiting
East Kent Hospitals University NHS Foundation TrustCanterbury, United KingdomRecruiting
Velindre Cancer CentreCardiff, United KingdomRecruiting
Colchester HospitalColchester, United KingdomRecruiting
Royal Derby HospitalDerby, United KingdomRecruiting
NHS LothianEdinburgh, United KingdomRecruiting
Royal Devon and Exeter HospitalExeter, United KingdomRecruiting
Beatson West of Scotland Cancer CentreGlasgow, United KingdomRecruiting

+ 25 more locations — full list on the registry record.

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