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Carcinoma, Non-Small-Cell LungPhase 1NCT06566443

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

A Phase 1 study testing Honokiol in people with Carcinoma, Non-Small-Cell Lung, run by The Methodist Hospital Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Honokiol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
13 Feb 2025to Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed.
  • Male or female, 18 years of age or older, on the day of informed consent signing.
  • Early stage NSCLC eligible for upfront definitive surgical resection
  • Measurable disease according to the Response evaluation criteria in solid tumors (RECIST 1.1) within 30 days of treatment.
  • Expected life expectancy of at least 6 months
  • Adequate organ and marrow function as defined below:
  • Hemoglobin ≥9.0 g/dl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility) Absolute neutrophil count ≥1000/μL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility) Platelet count ≥100,000/μL (without transfusion within 2 weeks of laboratory test used to determine eligibility)- Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB [>1.5 x ULN] is allowed), Aspartate transaminase/alanine transaminase ≤5 x institutional ULN Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min/1.
  • Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.

Who cannot join

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration.
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from Adverse Events (AEs) due to a previously administered agent.
  • Use of agents that target the mitochondrial metabolism.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
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  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
  • Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. If patient received major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the trial treatment.
  • Active infection requiring systemic therapy.
  • Confirmed positive pregnancy test in women of childbearing potential (WOCBP).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Houston Methodist Neal Cancer Center

    Houston, Texas, 77030

    Jun Zhang, MD, 713-441-9948, ccresearch@houstonmethodist.org

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Honokiol
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HonokiolDrug

    Also called Honopure (Dietary supplement)

    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.

Study groups in NCT06566443
Study groupRoleWhat they receive
HonokiolExperimentalApproximately, 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)
Receives: Drug: Honokiol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (4)
  1. 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;

    Measured: DLT period will start with initial treatment dose until 21 days after.

  2. 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.

    Measured: From initial treatment dose until 21 days after.

  3. Number of participants with tumor necrosis

    To assess for any evidence of tumor necrosis.

    Measured: From screening tissue collection to post-intervention tissue collection, an average of 3 months.

  4. 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.

    Measured: The safety period will start at baseline and will be assessed through study completion, up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start13 Feb 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06566443
Sponsor's protocol ID
PRO00037422 (HMCC-LU22-001)
Status last verified
May 2026
First submitted
9 Aug 2024
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hsu PP, Sabatini DM. Cancer cell metabolism: Warburg and beyond. Cell. 2008 Sep 5;134(5):703-7. doi: 10.1016/j.cell.2008.08.021.

    PubMed 18775299
  • Barger JF, Plas DR. Balancing biosynthesis and bioenergetics: metabolic programs in oncogenesis. Endocr Relat Cancer. 2010 Sep 23;17(4):R287-304. doi: 10.1677/ERC-10-0106. Print 2010 Dec.

    PubMed 20699334
  • Cheng G, Zielonka J, Dranka BP, McAllister D, Mackinnon AC Jr, Joseph J, Kalyanaraman B. Mitochondria-targeted drugs synergize with 2-deoxyglucose to trigger breast cancer cell death. Cancer Res. 2012 May 15;72(10):2634-44. doi: 10.1158/0008-5472.CAN-11-3928. Epub 2012 Mar 19.

    PubMed 22431711
  • Liu H, Hu YP, Savaraj N, Priebe W, Lampidis TJ. Hypersensitization of tumor cells to glycolytic inhibitors. Biochemistry. 2001 May 8;40(18):5542-7. doi: 10.1021/bi002426w.

    PubMed 11331019
  • Kurtoglu M, Lampidis TJ. From delocalized lipophilic cations to hypoxia: blocking tumor cell mitochondrial function leads to therapeutic gain with glycolytic inhibitors. Mol Nutr Food Res. 2009 Jan;53(1):68-75. doi: 10.1002/mnfr.200700457.

    PubMed 19072739
  • Lampidis TJ, Bernal SD, Summerhayes IC, Chen LB. Selective toxicity of rhodamine 123 in carcinoma cells in vitro. Cancer Res. 1983 Feb;43(2):716-20.

    PubMed 6848187
  • Pathania D, Millard M, Neamati N. Opportunities in discovery and delivery of anticancer drugs targeting mitochondria and cancer cell metabolism. Adv Drug Deliv Rev. 2009 Nov 30;61(14):1250-75. doi: 10.1016/j.addr.2009.05.010. Epub 2009 Aug 27.

    PubMed 19716393
  • Chen F, Wang T, Wu YF, Gu Y, Xu XL, Zheng S, Hu X. Honokiol: a potent chemotherapy candidate for human colorectal carcinoma. World J Gastroenterol. 2004 Dec 1;10(23):3459-63. doi: 10.3748/wjg.v10.i23.3459.

    PubMed 15526365
  • Tsai TH, Chou CJ, Cheng FC, Chen CF. Pharmacokinetics of honokiol after intravenous administration in rats assessed using high-performance liquid chromatography. J Chromatogr B Biomed Appl. 1994 Apr 22;655(1):41-5. doi: 10.1016/0378-4347(94)00031-x.

    PubMed 8061832
  • Sporn MB, Suh N. Chemoprevention of cancer. Carcinogenesis. 2000 Mar;21(3):525-30. doi: 10.1093/carcin/21.3.525.

    PubMed 10688873
  • Lippman SM, Lee JJ, Sabichi AL. Cancer chemoprevention: progress and promise. J Natl Cancer Inst. 1998 Oct 21;90(20):1514-28. doi: 10.1093/jnci/90.20.1514. No abstract available.

    PubMed 9790544
  • Kelloff GJ, Sigman CC, Greenwald P. Cancer chemoprevention: progress and promise. Eur J Cancer. 1999 Dec;35(14):2031-8. doi: 10.1016/s0959-8049(99)00299-3.

    PubMed 10711244
  • Xu HL, Tang W, Du GH, Kokudo N. Targeting apoptosis pathways in cancer with magnolol and honokiol, bioactive constituents of the bark of Magnolia officinalis. Drug Discov Ther. 2011 Oct;5(5):202-10. doi: 10.5582/ddt.2011.v5.5.202.

    PubMed 22466367
  • Chiang CK, Sheu ML, Hung KY, Wu KD, Liu SH. Honokiol, a small molecular weight natural product, alleviates experimental mesangial proliferative glomerulonephritis. Kidney Int. 2006 Aug;70(4):682-9. doi: 10.1038/sj.ki.5001617.

    PubMed 16807544
  • Pan J, Zhang Q, Liu Q, Komas SM, Kalyanaraman B, Lubet RA, Wang Y, You M. Honokiol inhibits lung tumorigenesis through inhibition of mitochondrial function. Cancer Prev Res (Phila). 2014 Nov;7(11):1149-59. doi: 10.1158/1940-6207.CAPR-14-0091. Epub 2014 Sep 22.

    PubMed 25245764

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Honokiol in people with Carcinoma, Non-Small-Cell Lung, run by The Methodist Hospital Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Zhang, MD (713-441-6698, jzhang22@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose of Honokiol therapy (time frame: From treatment initiation of each patient, assessed up to 21 days after treatment initiation of final patient, up to 2 years after first enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06566443, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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