A Clinical Trial of Low Dose Aspirin versus Placebo in High-Risk Individuals of Lung Cancer.

Phase 1

• Conditions: ung cancer increased risk in current or former heavy smokers, with CT SCAN screen detected subsolid lung nodules (Cosmos Project); MedDRA version: 17.0Level: PTClassification code 10025065Term: Lung carcinoma cell type unspecified recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-004862-32-IT
• Lead Sponsor: Istituto Europeo Oncologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

•Asymptomatic current or former smokers (having stopped within the last 20 years),
•Age > 50 years (risk of lung cancer in subjects under 50 is low thus screening is not indicated by actual international guidelines).
•Smoking history > 20 pack/years, subjects must be included in an ongoing annual screening with low dose CT scan (Cosmos 1 or Cosmos 2).
•Subjects must have subsolid (non solid or partially solid) nodules with size between 4 and 10 mm with any Volume Doubling Time (VDT) and/or
subsolid (non solid or partially solid) nodule larger than 10 mm with VDT higher than 400 days and not candidate to surgical excision.
•All nodules should be persistent at least after three months follow up with ld-CT
•ECOG performance status =1 (Karnofsky =70%; see Appendix A)
•Participants must have normal organ and marrow function
•Ability to understand and the willingness to sign a written informed consent document.
•Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

•Subjects with chronic treatment (at least twice/week for more than 3 months) with Aspirin or other NSAIDs (representing 15% of Cosmos 1 population)
•History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, COX2 inhibitors
•Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization
•History of therapeutic doses of anticoagulants
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant women are excluded from this study because Aspirin is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Aspirin, breastfeeding should be discontinued if the mother is treated with Aspirin
•Participants with bleeding diathesis, history of gastric/duodenal ulcers, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. = 2 alcohol drinks a day.
•Participants who in the opinion of the PI will be at higher risk of ASA-related complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified