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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)

Study acronym: REFINE-Lung
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 25 to 37v4
  2. Study sites: 4 to 25 Eligibility criteria expanded, about 55 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 55 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Jun 1, 2022 to Jun 23, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 1, 2022 to Jun 23, 2022
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05085028
Lead Sponsor Imperial College London
Collaborators: National Institute for Health Research, United Kingdom, Medical Research Council, University College, London
Conditions Lung Cancer, Nonsmall Cell
Enrollment 1,750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov