Oral Iloprost for the Prevention of Lung Cancer In Former Smokers
NCT05411107 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2024-05-17
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.
Conditions
- Bronchial Epithelial Dysplasia
- Chronic Obstructive Pulmonary Disease
- Lung Carcinoma
- Stage I Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Tobacco-Related Carcinoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo collection of sputum sample
- PROCEDURE
-
Bronchial Brush Biopsy
Undergo bronchial brush biopsy
- PROCEDURE
-
Bronchoscopy
Undergo bronchoscopy
- DRUG
-
Iloprost
Given PO
- DRUG
-
Placebo Administration
Given PO
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
York E Miller · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2026-12-01
- Completion
- 2027-06-30
- FDA Drug
- Yes
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