Electro-Acupuncture in Lung cancER : EALER Study

This multicenter, randomized controlled clinical trial designed to evaluate the efficacyand safety of electro‐acupuncture (EA) as an adjunctive therapy, combined with PD‐1inhibitors and chemotherapy, as a first‐line treatment for advanced NSCLC. This trialplans to enroll 424 patients with advanced NSCLC who are negative for actionable drivergene mutations, including but not limited to EGFR and ALK, and a PD‐L1 tumor proportionscore (TPS) below 50%. Through a central randomization system, participants will beallocated in a 1:1 ratio to either the EA group or the sham‐acupuncture control group.The intervention will be administered concurrently with the induction‐phase chemotherapycombined with PD‐1 inhibitor therapy, for a total of 4 to 6 cycles.The primary endpoint is progression‐free survival (PFS), defined as the time fromrandomization to the first documented disease progression or death. Secondary efficacyendpoints include overall survival (OS), objective response rate (ORR), disease controlrate (DCR), and duration of response (DoR). The symptom burden and health‐related qualityof life, will be assessed using the Lung Cancer Symptom Scale (LCSS) and the EuropeanOrganization for the Research and Treatment of Cancer Quality of Life Questionnaire‐Core30 (EORTC QLQ‐C30) with its lung cancer‐specific module (QLQ‐LC13). Safety andtolerability will be evaluated based on the incidence, severity, and causality of adverseevents, graded according to the Common Terminology Criteria for Adverse Events (CTCAE).Immune‐related adverse events (irAEs) will be specifically managed per the NCCNGuidelines for Management of Immunotherapy‐Related Toxicities. Efficacy analyses will beperformed on the full analysis set (FAS) following the intention‐to‐treat (ITT)principle. Sensitivity analyses will be conducted on the per‐protocol set (PPS) to assessthe robustness of the primary findings.