Current SmokerPhase 2NCT02169271
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
A Phase 2 study testing Aspirin and Laboratory Biomarker Analysis in people with Current Smoker and Former Smoker, run by National Cancer Institute (NCI) at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Current Smoker, Former Smoker, Multiple Pulmonary Nodules
- What is being tested?
- Aspirin and Laboratory Biomarker Analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Nov 2014to 14 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic current or former smokers (having stopped within the last 20 years)
- Smoking history >= 20 pack/years; subjects must be included in an ongoing annual screening with low dose CT scan or must have two consecutive CT outside the context of a screening program confirming subsolid nodules
- Subjects must have subsolid (non solid or partially solid) nodules with size between 4 and 10 mm with any volume doubling time (VDT) not candidate to surgical excision 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 1 dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule from the previous CT scan is allowed
- All current smokers should accept to receive support for smoking cessation
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
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- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 100,000/microliter
- Total bilirubin =< 2 x institutional upper limit of normal (ULN) and/or history of Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
- Serum creatinine =< institutional ULN
- Women of child-bearing potential (from first menstruation to 1 year after last menstruation) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Signed informed consent
Who cannot join
- Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, cyclooxygenase-2 (COX2) inhibitors
- Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is finished at least 18 months prior to randomization
- History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
- 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; breastfeeding should be discontinued if the mother is treated with aspirin
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- Individual may not be receiving any other investigational agents, antiplatelet agents (e.g. aspirin, clopidogrel [Plavix or others]), anticoagulants (e.g. heparin or heparinoids, Coumadin, or others), methotrexate, lithium
- Participants with bleeding diathesis, history of gastric/duodenal ulcers in the last 5 years, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. =< 3 alcohol drinks a day
- Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
- Participants with known inability to adequately absorb oral medication
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules
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.
Read the detailed description
PRIMARY OBJECTIVES:
- The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Aspirin, Laboratory Biomarker Analysis, Placebo
- Medical subject headings
- Smoking Cessation, Multiple Pulmonary Nodules, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic Acid, ASA, Aspergum, Ecotrin
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acetylsalicylic acid) | Experimental | Patients receive acetylsalicylic acid PO QD for 12 months. Receives: Drug: Aspirin; Other: Laboratory Biomarker Analysis |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO QD for 12 months. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
Measured: Twelve-month treatment
Secondary outcomes (8)
Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
Difference (12 month-baseline) in the sum of baseline target nodules diameters
Measured: Baseline up to 1 year
Change in Lesion Volume
Difference (12 month-baseline) in lesion volume
Measured: Baseline to 1 year
Change in Lesion Density
Difference (12 month-baseline) in lesion density
Measured: Baseline up to 1 year
Modulation of Thromboxane B2
Difference (12 month-baseline) in biomarker concentration
Measured: Baseline up to 1 year
Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
Difference (12 month-baseline) in biomarker concentration
Measured: Baseline up to 1 year
Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
Difference (12 month-baseline) in biomarker concentration
Measured: Baseline up to 1 year
Modulation of High Sensitive CRP
Difference (12 month-baseline) in biomarker concentration
Measured: Baseline up to 1 year
Modulation of miRNA Prediction Risk Score
Difference (12 month-baseline) of the score on a scale (scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value<0 is considered negative, a value ≥0 positive for lung cancer).
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start21 Nov 2014
- Primary completion13 Jul 2018
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Current SmokerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bernardo Bonanni, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169271
- Sponsor's protocol ID
- NCI-2014-01311
- Other IDs
- NCI-2014-01311, IEO-833/13F, HHSN261201200034I, EIO 833/13F, 2013-004862-32, TO-RFP A, N01-CN-2012-00034, IEO 833/13F (IEO37)
- Status last verified
- May 2020
- First submitted
- 19 Jun 2014
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules
- ClinicalTrials.gov ID
- NCT02169271
- Acronym / sponsor ID
- NCI-2014-01311
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Nov 2014 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acetylsalicylic acid) | Experimental | Drug: Aspirin, Other: Laboratory Biomarker AnalysisPatients receive acetylsalicylic acid PO QD for 12 months. |
| Arm II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: PlaceboPatients receive placebo PO QD for 12 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Asymptomatic current or former smokers (having stopped within the last 20 years)
- Smoking history >= 20 pack/years; subjects must be included in an ongoing annual screening with low dose CT scan or must have two consecutive CT outside the context of a screening program confirming subsolid nodules
- Subjects must have subsolid (non solid or partially solid) nodules with size between 4 and 10 mm with any volume doubling time (VDT) not candidate to surgical excision 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 1 dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule from the previous CT scan is allowed
- All current smokers should accept to receive support for smoking cessation
Key exclusion criteria (10 listed)
- Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, cyclooxygenase-2 (COX2) inhibitors
- Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is finished at least 18 months prior to randomization
- History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Acetylsalicylic Acid, ASA, Aspergum, EcotrinGiven PO | Drug | Arm I (acetylsalicylic acid) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (acetylsalicylic acid), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
Primary outcome
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
Time frame: Twelve-month treatment
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
8 secondary outcomes
Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
Time frame: Baseline up to 1 year
Change in Lesion Volume
Time frame: Baseline to 1 year
Change in Lesion Density
Time frame: Baseline up to 1 year
Modulation of Thromboxane B2
Time frame: Baseline up to 1 year
Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
Time frame: Baseline up to 1 year
Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
Time frame: Baseline up to 1 year
Modulation of High Sensitive CRP
Time frame: Baseline up to 1 year
Modulation of miRNA Prediction Risk Score
Time frame: Baseline up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardo Bonanni principal investigator
M.D. Anderson Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin and Laboratory Biomarker Analysis in people with Current Smoker and Former Smoker, run by National Cancer Institute (NCI) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis) (time frame: Twelve-month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.