Study of Electroacupuncture Combined With PD-1 Inhibitor Therapy for Older Adults with Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of combining electroacupuncture with PD-1 inhibitor therapy in elderly patients aged 65 and older who have advanced non-small cell lung cancer NSCLC. This multicenter, randomized controlled trial aims to determine if adding electroacupuncture to PD-1 inhibitors improves treatment outcomes and safety compared to PD-1 inhibitors combined with sham electroacupuncture. The study also explores biomarkers to identify which patients may benefit most from this combined approach. Participants will be randomly assigned to one of two groups one receiving electroacupuncture plus PD-1 inhibitor therapy, and the other receiving sham electroacupuncture plus PD-1 inhibitor therapy. The PD-1 inhibitor is given in cycles every 21 days, with 4 to 6 treatment cycles followed by optional maintenance therapy. Electroacupuncture or sham treatments start on the same day as the PD-1 inhibitor cycle, administered once daily for five sessions per cycle, lasting 20 minutes each, targeting specific acupuncture points. During the study, participants will undergo evaluations including progression-free survival as the primary outcome, with additional measures such as response rate, quality of life, immune function, and traditional Chinese medicine syndrome scores. Safety is closely monitored. Peripheral non-coding RNA samples will be collected at the start to study gene expression related to treatment response. The study duration and follow-up span up to 100 months for outcome assessment.

Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC