Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

BACKGROUND: This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases. MATERIALS AND METHODS: Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime. RESULTS: All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks). CONCLUSION: FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.