RecruitingPhase 1NCT06566443

Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer

Phase I Trial Evaluating the Safety of the Dietary Supplement Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer

Sponsor

The Methodist Hospital Research Institute

Enrollment

15 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

This is a Phase I Trial evaluating the safety of the dietary supplement honokiol for lung cancer chemoprevention. Female or male patients aged 18 years, or older, with early stage lung cancer who have been scheduled for curative surgery will be eligible for participation in the study. The study will only enroll patients with stage I lung cancers less than 4 cm, given the recent approval of neoadjuvant chemotherapy and nivolumab for stage IB tumors \> 4 cm. Approximately, 15 patients will be enrolled in the study. They will take the study drug, honokiol, for 2 weeks prior to the surgery. The primary endpoint will be the Maximum Tolerated Dose (MTD) of honokiol.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing honokiol — a natural compound found in magnolia bark — in patients with early-stage non-small cell lung cancer (NSCLC) who are scheduled for surgery, to evaluate whether it is safe and shows any signs of anti-tumor activity before surgery. **You may be eligible if...** - You are 18 or older with early-stage NSCLC that can be surgically removed - Surgery is planned as your main treatment - You have not started other cancer treatment yet - You have adequate blood counts, liver function, and kidney function - Your expected survival is at least 6 months **You may NOT be eligible if...** - You are currently receiving or have recently received another cancer drug or radiation - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems - You have had a prior lung cancer diagnosis or recent major surgery - You have active autoimmune disease requiring high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHonokiol

Honokiol will be given orally at a starting dose of 1 capsule (250 mg/ capsule) per day for 2 weeks. Dose levels will escalate based on dose-limiting toxicity occurrence. We will start at one capsule (250 mg) once daily, dose 0 would be one capsule (250 mg) twice daily, dose +1 would be 500mg in the AM and 250mg in the evening, and +2 would be 500 mg twice daily.

Locations(1)

Houston Methodist Neal Cancer Center

Houston, Texas, United States

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NCT06566443

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