KEY TAKEAWAYS
- The REFINE-Lung phase III trial aimed to determine the optimal frequency of pembrolizumab in NSCLC by evaluating the frequency-response relationship.
- The primary endpoint is to determine the optimal dose frequency of pembrolizumab. Secondary endpoints include OS, PFS, ORR, DoR, AEs, QoL, and cost-effectiveness.
Conventional trial designs are not ideal for optimizing pembrolizumab dosing due to high costs, toxicity, and the need for multiple trials.
Researchers aimed to determine the optimal frequency of pembrolizumab in non-small cell lung cancer (NSCLC) by evaluating the frequency-response relationship.
The study will include 1,750 patients (pts) aged 18 and older who are free of disease progression after six months of their first-line treatment with pembrolizumab. These pts will be randomly assigned to one of five groups to determine the best dosing frequency. Initially, pts will be divided equally between a control group receiving treatment every 6 weeks (q6w) and an experimental group receiving treatment every 12 weeks (q12w). An interim analysis will occur when 37 disease progression events are observed in the control group. If q12w treatment doesn’t significantly worsen progression-free survival (PFS), the trial will include q9w, q15w, and q18w arms. Pts who progress on a reduced-frequency regimen may return to q6w treatment.
The primary endpoint is determining pembrolizumab’s optimal continuing dose frequency, defined as the longest dose interval non-inferior to standard therapy, using 2-year survival as the primary outcome. Secondary endpoints include overall survival(OS), PFS, overall response rate(ORR), duration of response, adverse events, quality of life(QoL), and cost-effectiveness. An exploratory sub-study will investigate cancer immunotherapy and develop new biomarkers for response, resistance, toxicity, and patient suitability for dose de-escalation.
The study is still enrolling pts and is open at 16 centers.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05085028
Michael Seckl, Ehsan Ghorani, Matteo Quartagno, Fiona Helen Blackhall, Duncan C. Gilbert, Mary E.R. O’Brien, Christian H.H Ottensmeier, Elena Pizzo, James F. Spicer, Alex Williams, Philip David Badman, and Mahesh K. B. Parmar.
DOI: 10.1200/JCO.2023.41.16_suppl.TPS9145 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS9145-TPS9145.
