Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer
NCT Number: NCT06566443
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: DRUG: Honokiol
Sponsor: The Methodist Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2027-08
Locations: Houston Methodist Neal Cancer Center, Houston, Texas, 77030, United States

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.

Primary Outcome Measures: Maximum Tolerated Dose of Honokiol therapy, To determine the maximum tolerated dose (MTD) of honokiol therapy in patients with stage I NSCLC, less than 4 cm, who will undergo surgical resection. Review the safety data to determine the dose level at which the maximum tolerable level of toxicity is observed and select as the MTD the dose for which the isotonic estimate of the DLT rate is closest to the target DLT rate., From treatment initiation of each patient, assessed up to 21 days after treatment initiation of final patient, up to 2 years after first enrollment.
Secondary Outcome Measures: Dose Limiting Toxicities of Honokiol therapy, To determine the dose-limiting toxicity (DLT) and other toxicities associated with honokiol therapy, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0;, DLT period will start with initial treatment dose until 21 days after.|Recommended Phase 2 Dose of Honokiol therapy, To determine the recommended Phase II dose (RP2D) of honokiol; Bayesian Optimal Interval (BOIN) design will be used for dose finding., From initial treatment dose until 21 days after.|Number of participants with tumor necrosis, To assess for any evidence of tumor necrosis., From screening tissue collection to post-intervention tissue collection, an average of 3 months.|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, To determine the safety and tolerability of honokiol therapy prior to surgery as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0., The safety period will start at baseline and will be assessed through study completion, up to 2 months
Other Outcome Measures: Tissue immune correlative biomarkers of honokiol therapy, To evaluate tissue immune correlative biomarkers of honokiol therapy, including but not limited to Ki67, a good standard for the measurement of cell proliferation., From pre-intervention blood collection to post-intervention blood collection, an average of 2 weeks.