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)

• Status: Not yet recruiting
• Trial end date: 2027-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: Medical Research Council; National Institute for Health Research, United Kingdom; University College, London
• Treatments: Pembrolizumab

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