RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-08

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06566443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 3. Stage I Non Small Cell Lung Cancer, tumor less than 4 cm 4. Measurable disease according to the Response evaluation criteria in solid tumors (RECIST 1.1) within 30 days of treatment. 5. Expected life expectancy of at least 6 months 6. Adequate organ and marrow function as defined below: 7. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.	1. 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. 2. 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. 3. Use of agents that target the mitochondrial metabolism. 4. 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. 5. 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). 6. 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. 7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 8. Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2. 9. 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. 10. Active infection requiring systemic therapy. 11. Confirmed positive pregnancy test in women of childbearing potential (WOCBP).

Inclusion Criteria

Exclusion Criteria

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.
3. Stage I Non Small Cell Lung Cancer, tumor less than 4 cm
4. Measurable disease according to the Response evaluation criteria in solid tumors (RECIST 1.1) within 30 days of treatment.
5. Expected life expectancy of at least 6 months
6. Adequate organ and marrow function as defined below:
7. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.

1. 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.
2. 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.
3. Use of agents that target the mitochondrial metabolism.
4. 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.
5. 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).
6. 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.
7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
8. Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
9. 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.
10. Active infection requiring systemic therapy.
11. Confirmed positive pregnancy test in women of childbearing potential (WOCBP).

Contacts and Locations

Study Contact

Jun Zhang, MD

CONTACT

713-441-6698

jzhang22@houstonmethodist.org

Principal Investigator

Jun Zhang, MD

PRINCIPAL_INVESTIGATOR

Houston Methodist Neal Cancer Center

Study Locations (Sites)

Houston Methodist Neal Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Jun Zhang, MD, PRINCIPAL_INVESTIGATOR, Houston Methodist Neal Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-08

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Carcinoma, Non-Small-Cell Lung