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Honokiol for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Jun Zhang, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. The patient provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed.
2. Male or female, 18 years of age or older, on the day of informed consent signing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening tissue collection to post-intervention tissue collection, an average of 3 months.
Awards & highlights

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.

Who is the study for?
This trial is for men and women over 18 with early-stage Non-Small Cell Lung Cancer scheduled for curative surgery. Only patients with stage I lung cancers smaller than 4 cm are eligible, due to recent treatments approved for larger tumors.
What is being tested?
The study tests the safety of honokiol, a dietary supplement, as a preventive treatment for lung cancer. About 15 participants will take honokiol for two weeks before their surgery to find the highest dose they can tolerate without severe side effects.
What are the potential side effects?
Since this is a Phase I trial primarily focused on determining the Maximum Tolerated Dose (MTD) of honokiol, specific side effects are not listed but may include typical reactions to new supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening tissue collection to post-intervention tissue collection, an average of 3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening tissue collection to post-intervention tissue collection, an average of 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose of Honokiol therapy
Secondary study objectives
Dose Limiting Toxicities of Honokiol therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with tumor necrosis
+1 more
Other study objectives
Tissue immune correlative biomarkers of honokiol therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: HonokiolExperimental Treatment1 Intervention
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 and this will be determined using Bayesian Optimal Interval Design (BOIN)

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
279 Previous Clinical Trials
81,269 Total Patients Enrolled
Jun Zhang, MDPrincipal InvestigatorHouston Methodist Neal Cancer Center
2 Previous Clinical Trials
322 Total Patients Enrolled
~10 spots leftby Aug 2026
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