Clinical Design and Objectives

This study is a Phase I clinical trial primarily aimed at determining the maximum tolerated dose (MTD) of the dietary supplement Honokiol. Safety will be monitored after a two‑week pre‑operative administration, and identifying the dose‑limiting threshold is the key endpoint. Early safety data will provide critical justification for the design of subsequent multi‑center expansion trials.

Patient Population and Treatment Setting

Participants are patients with stage I non‑small cell lung cancer (NSCLC) whose tumor diameter is ≤ 4 cm and who are scheduled for surgery. In the United States, tumors > 4 cm are eligible for the newly approved adjunctive therapy and immune checkpoint inhibitor nivolumab; therefore, this study focuses on a cohort of small tumors for which therapeutic options remain limited.

Differentiation and Expected Benefits

Unlike conventional chemotherapy or immunotherapy, Honokiol is a naturally derived compound and is expected to have a relatively favorable safety profile. If safety is confirmed, pre‑operative prophylactic administration could potentially reduce the risk of recurrence.

Future Development and Impact

Should safety data be established, the program could be expanded into multi‑center Phase II/III trials. Success would position Honokiol as a novel preventive strategy for early‑stage lung cancer patients and could positively influence the dietary‑supplement‑based cancer prevention market.