Actively Recruiting
Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer
Led by The Methodist Hospital Research Institute · Updated on 2025-06-17
15
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient provides written informed consent
- Male or female, 18 years of age or older at consent
- Early stage non-small cell lung cancer eligible for upfront surgical removal
- Measurable tumor within 30 days before treatment according to RECIST 1.1 criteria
- Expected life expectancy of at least 6 months
- Adequate organ and marrow function with specific blood count and liver/kidney test thresholds
- Willing and able to follow study procedures and attend scheduled visits
You will not qualify if you...
- Currently in another study or received investigational therapy/device within 3 weeks before treatment
- Received chemotherapy, targeted therapy, or radiation within 2 weeks before treatment or not recovered from prior side effects
- Use of drugs targeting mitochondrial metabolism
- Having another progressing cancer requiring active treatment, except certain skin or cervical cancers
- Serious or uncontrolled medical conditions such as severe lung disease, low kidney function, major digestive surgery, or chronic bowel disease causing significant diarrhea
- Conditions or treatments interfering with study participation or safety
- Psychiatric or substance abuse disorders affecting cooperation
- ECOG performance status 2 or higher
- Not recovered from adverse effects of prior therapies (except mild neuropathy)
- Active infection needing systemic therapy
- Positive pregnancy test in women able to become pregnant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jun Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
1
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