A Single-Arm Phase II Study of Bronchial Artery Chemoembolization (BACE) Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Without Standard Treatment Options

This prospective, open-label, single-arm Phase II study is designed to investigate BACE-based combination therapy in patients with advanced non-small cell lung cancer who have exhausted, progressed after, or are unable to tolerate available standard systemic treatments. The study focuses on patients with clinically relevant intrathoracic tumor lesions that remain technically suitable for bronchial arterial intervention.

BACE is intended to provide concentrated locoregional treatment to lung tumors through the bronchial arterial circulation. During the procedure, tumor-feeding bronchial arteries will be identified by angiography and selectively catheterized in accordance with the protocol. Protocol-specified chemotherapeutic agents will then be administered through the target arteries, followed by embolization of the tumor-feeding vessels. This approach is intended to increase drug exposure within the tumor while reducing arterial blood supply and inducing tumor ischemia and necrosis.

BACE will be administered in combination with protocol-defined systemic anti-tumor treatment. The systemic treatment include chemotherapy, immune checkpoint inhibition, targeted therapy, or another protocol-permitted regimen, as appropriate for the participant's tumor molecular profile, previous treatment history, organ function, clinical condition, and prior treatment tolerance. The timing and administration of systemic therapy in relation to BACE will follow the study protocol. There is no control group or placebo treatment in this study.

Before treatment, participants will undergo protocol-specified baseline clinical, laboratory, and imaging assessments. Contrast-enhanced chest computed tomography will be used to document measurable intrathoracic lesions and establish the baseline tumor burden. Follow-up imaging will be performed at protocol-defined intervals to evaluate changes in target lung lesions and overall disease status according to RECIST criteria. Local progression of the treated intrathoracic lesions will be distinguished from progression occurring at other pulmonary or extrapulmonary sites.

Safety monitoring will cover both procedure-related complications and toxicities associated with the combined systemic treatment. Clinical symptoms, laboratory abnormalities, imaging findings, and adverse events will be evaluated throughout treatment and during the protocol-defined safety follow-up period. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. Investigators will assess the relationship of each adverse event to BACE, embolization, intra-arterial chemotherapy, and concomitant systemic anti-tumor therapy.