Bronchial Arterial Chemoembolization Combined with Tislelizumab for Non-Small Cell Lung Cancer: An Exploratory, Prospective, Single-Arm, Phase II Trial.

[PURPOSE] To assess the effectiveness and safety of bronchial arterial chemoembolization (BACE) combined with tislelizumab for advanced non-small cell lung cancer (NSCLC).

[MATERIALS AND METHODS] In a prospective single-arm, Phase II study, patients with Stage IIIA-IIIC NSCLC who refused or were ineligible for standard treatments were enrolled. Patients received BACE followed by 200-mg tislelizumab every 3 weeks until disease progression, intolerable toxicities, or discontinuation determined by the investigators. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life (QoL).

[RESULTS] Thirty patients (median age, 67 years, 24 men) were enrolled between December 2021 and August 2022. The median follow-up was 23 months (95% CI, 21.5-24.5). At data cutoff (March 1, 2024), median PFS was 10.5 months (95% CI, 7.8-13.2), and median OS was 15.0 months (95% CI, 8.2-21.8). ORR was 60.0% (18 of 30 patients), and DCR was 80.0% (24 of 30 patients). PD-L1 expression, tumor feeding arteries, and previous treatment history were prognostic factors for PFS and OS. Throughout the treatment and follow-up period, no Grade ≥3 treatment-related adverse events (TRAEs) were observed, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Common Grade 1-2 TRAEs were nausea, chest pain, and anemia. QoL (global, physical, and emotional functioning) improved significantly after 1 treatment cycle versus baseline.

[CONCLUSIONS] The prospective study suggests that BACE plus tislelizumab offer promising effectiveness and acceptable safety in advanced NSCLC, supporting further randomized trials.