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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06566443
What this study is testing
What is Honokiol?
Honokiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for carcinoma, non-small-cell lung.
Also referred to as Honopure (Dietary supplement).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as...
- 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
You likely can't join if
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an...
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not...
- 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...
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation...
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the...
See the full eligibility criteria
- 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...
- Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Active infection requiring systemic therapy.
- Confirmed positive pregnancy test in women of childbearing potential (WOCBP).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.