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.
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.
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.
Parallel
Pembrolizumab 25 MG/ML [Keytruda]
DrugPembrolizumab to be given at 400mg intravenous over 5 different frequencies
Overall survival at 2 years
Survival at 2 years, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination
Overall survival from study entry
Survival, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination
Progression free survival
Progression free survival as assessed by RECIST v1.1, defined as time from study entry to first evidence of disease progression or death due to any cause
Overall response rate
Overall response rate (ORR) as assessed by RECIST v1.1, defined as complete response (CR) or partial response (PR)
Duration of response
Duration of response (DoR) as assessed by RECIST v1.1, defined as time from study entry to change in response from CR or PR to stable disease (SD) or progressive disease (PD)
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Imperial College London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Medical Research Council
Collaborator
University College, London
Collaborator
