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Triple-Pronged attack on lung cancer: aspirin, smoking cessation, and lifestyle changes tested in new trial

NCT ID NCT03654105

Prevention Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of low-dose aspirin, a smoking cessation drug called cytisine, and guidance on diet and exercise can reduce chronic inflammation and lower lung cancer risk in heavy smokers aged 55 to 75. The 2000 participants will also receive annual low-dose CT scans for early detection. The goal is to see if this multi-pronged approach can lower inflammation levels and help people quit smoking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-dose aspirin (acetylsalicylic acid) and cytisine (a smoking cessation aid)
What this could lead to
If it works, this could point toward a practical combination of lifestyle changes and medication to lower lung cancer risk in long-term smokers.
What could go wrong
This is a mid-stage pilot study with 2000 participants, so results are not definitive. The benefits may be small, and aspirin can cause bleeding or stomach issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 55 and 75 years * High consumption of cigarettes (≥ 30 packs/year) * Elegibility to annual LDCT screening * Confidence in Internet use * Absence of tumors for at least 5 years * Signed informed consent form Exclusion Criteria: * Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch, coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate) * Chronic treatment with acetylsalicylic acid, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol) * Treatment with methotrexate * Existing Mastocytosis * History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs * Gastroduodenal ulcer * Hemorrhagic diathesis * Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency) * Serious psychiatric problems * Previous treatment with Cytisine * Abuse of alcohol or other substances (even previous)

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease lung neoplasm Motor Activity Smoking Cessation lung cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diet modification Inflammation Lung cancer Physical activity Smoking cessation

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

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