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)

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 sta

Trial Details

NCT ID
NCT05085028
Phase
PHASE3
Sponsor
Imperial College London
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pembrolizumab 25 MG/ML [Keytruda]
Locations (sample)
  • Bournemouth, United Kingdom|50.72048,-1.8795
  • Brighton, United Kingdom|50.82838,-0.13947
  • Bristol, United Kingdom|51.45523,-2.59665
  • Burton-on-Trent, United Kingdom|52.80728,-1.64263
  • Cambridge, United Kingdom|52.2,0.11667

Key Eligibility 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…

For full eligibility, visit ClinicalTrials.gov.

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