Bawei Aiguning Granules For Lung Cancer Bone Metastases: A Randomized, Double-blind, Placebo-Controlled Trial...

Bone metastases (BM) frequently lead to skeletal-related events (SREs) and significant pain in lung cancer patients, requiring more effective supportive management strategies. We designed a prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate Bawei Aiguning Granules (BWAGN) in combination with standard bone-targeted therapy. A total of 156 patients will be randomized across six centers. The primary endpoint is the 1-year incidence of SREs. Secondary endpoints include time to first SRE, pain assessment, quality of life, survival, Traditional Chinese Medicine symptom score, and bone turnover markers. Safety will be assessed according to Common Terminology Criteria for Adverse Events v5.0. Alongside the trial protocol, this manuscript presents currently available descriptive observations from a representative participant. During follow-up, no SREs were documented, and serial Electron Computed Tomography (ECT) examinations showed no obvious new imaging abnormalities suggestive of bone progression or SRE-related change. Functional status, symptom burden, and tumor markers showed favorable changes over time, while routine safety assessments remained generally stable, with no adverse events or serious adverse events recorded. These observations are descriptive only and should be interpreted with caution. Definitive conclusions regarding efficacy and safety will require completion of the protocol-defined follow-up and formal analysis of the full study cohort.