WithdrawnPhase 2

Oral Iloprost for the Prevention of Lung Cancer In Former Smokers

Stopped: Agent is not available

0Started 2024-06-01

Plain-language summary

This phase II trial tests whether oral iloprost works in preventing lung cancer (chemoprevention) in former smokers. Oral iloprost has previously been shown to reduce abnormal lung cells in former smokers, suggesting a clinically significant impact on lung cancer risk. The use of oral iloprost may help keep cancer from forming and reduce abnormal cells in the lung in order to lower the risk of developing lung cancer in former smokers.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must be former smokers (\> 12 months abstinent and confirmed by serum cotinine) with at least a 30 pack-year cigarette history who are at high risk for the development of lung cancer with at least one of the following: * Stage I or II lung cancer survivors, surgically treated with curative intent, who have remained disease free for \> 12 months. Participants may have been treated with adjuvant chemotherapy or targeted therapy \[(e.g. Osimertinib for epidermal growth factor receptor (EGFR) mutation)\], if appropriate, provided they are \> 12 months from the last systemic adjuvant therapy dose. * Patients with chronic obstructive pulmonary disease (COPD), defined as either airflow obstruction (forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] \< 0.70) on spirometry or emphysema (as commented on in a Radiology report) on CT scan. * Patients who display a ground glass opacity (GGO) on CT with a largest diameter =\< 10 mm and \>= 4 mm on axial imaging. The GGO must either be documented to have remained the same size or slowly progressing, but not regressing, over a 6-month period of observation by serial CT scan such that further workup beyond observation is not planned. A solid component of =\< 1/3 of the axial diameter may be present, providing the treating physician(s) do not plan on workup for resection within the next 6 months, taking both the character of the lesion and its rate of growth into consideration…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has been withdrawn — do you know why it was withdrawn, and does that affect whether oral iloprost is still considered a promising option for lung cancer prevention in former smokers?
2Since this was a Phase 2 trial focused on measuring changes in bronchial dysplasia through bronchoscopy, what would that repeated bronchoscopy process actually involve for me, and are there other studies still actively testing similar approaches that I might be eligible for?
3The trial was targeting people with bronchial epithelial dysplasia and a smoking history — given my own diagnosis and lung history, is my situation similar enough that the research behind this trial is still relevant to my care?
4Because this study was measuring dysplasia grade rather than actual lung cancer outcomes, what does that mean for how much we'd really know about whether iloprost prevents cancer — and is there stronger evidence from other sources my doctor could point me to?
5Are there currently approved or standard-of-care options for reducing lung cancer risk in former smokers with COPD or early dysplasia that I should be discussing instead, given that this trial is no longer enrolling?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in numerical grade of the worst (highest grade on the WHO scale) dysplastic lesion per subject on bronchoscopy

Timeframe: Baseline to 6 month follow up

Trial details

NCT IDNCT05411107

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Bronchial Epithelial Dysplasia trials