NCT02169271

Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules

A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules.

Detailed description

PRIMARY OBJECTIVES: I. The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer. SECONDARY OBJECTIVES: I. The modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters. II. The per-lesion analysis including the evaluation of lung nodule density before and after treatment, the number and size of non target lesions including solid nodules and evaluation of response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive acetylsalicylic acid orally (PO) once daily (QD) for 12 months. ARM II: Patients receive placebo PO QD for 12 months. After completion of study treatment, patients are followed up for 1 month.

Conditions

• Current Smoker
• Former Smoker
• Multiple Pulmonary Nodules
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Given PO

Timeline

• Start date: 2014-11-21
• Primary completion: 2018-07-13
• Completion: 2020-02-14
• First posted: 2014-06-23
• Last updated: 2020-05-21
• Results posted: 2020-05-21

Locations

2 sites across 2 countries: United States, Italy