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) utilising a novel multi-arm frequency-response optimisation design. 

Trial Aim

To determine the optimal continuing dose frequency of pembrolizumab amongst patients with non-small cell lung cancer (NSCLC) who have benefited from and completed 6 months of standard therapy.

Design

Multi-centre randomised open-label, utilising novel multi-arm frequency- response optimisation

ISRCTN70247820

NCT05085028

Information Sheet

REFINE-Lung information sheet

Centres

Eligible patients with NSCLC will initially be recruited from the following centres:

Additional centres may join the study at a later date. If you wish to take part, please speak to your oncologist.

Methods

Patients will be given an appropriate time period to consider participation (at least 24 hours). Written consent will be obtained from those patients who agree to participate and randomisation will be performed using OpenClinica eCRF. At each recruiting centre, a log of all approached and screened patients will be kept. Basic demographic data and reasons for non-eligibility will be recorded. Whilst participant baseline characteristics may vary slightly across recruiting sites, randomised treatment allocation will allow reliable assessment of the effects of reduced frequency treatment on survival rates.

Size of the trial

The trial plans to recruit 1750 patients over a 3.5 year period, initially comparing 6 and 12 weekly frequency of treatment. After interim analysis a further 3 arms will open, 9, 15 and 18 weekly frequencies.

Eligibility

Inclusion criteria

1. Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule
2. Any patient ≥18yrs who has received 6 months of pembrolizumab treatment, with or without chemotherapy, for advanced NSCLC who is planned to continue / move to immunotherapy every 6 weeks because of continued benefit

Exclusion criteria

1. Disease progression or not tolerating treatment at 6 months into therapy
2. Clinician does not intend to continue immunotherapy
3. 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.

Funding

This project was funded by the National Institute for Health Research (NIHR HTA) Programme (NIHR133011).