Oral Iloprost for the Prevention of Lung Cancer In Former Smokers (NCT05411107) | Clinical Trial Compass
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 range50 Years
SexALL
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…
What they're measuring
1
Change in numerical grade of the worst (highest grade on the WHO scale) dysplastic lesion per subject on bronchoscopy