EligibleTrials
Conditions › Lung cancer › NCT05085028

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)

Recruiting · NCT05085028 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London

View the official record on ClinicalTrials.gov →
Lung cancer

Interventions studied

Pembrolizumab 25 MG/ML [Keytruda]

What this trial is about

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.

Who can take part

Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

37 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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