Last reviewed · How we verify
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
Phase 2 trial testing Aspirin in Current Smoker in 109 participants. Completed in 14 February 2020.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 109 |
| Start date | 21 November 2014 |
| Primary completion | 13 July 2018 |
| Estimated completion | 14 February 2020 |
| Sites | 2 locations across Italy, United States |
National Cancer Institute (NCI)
50 and older, any sex, with Current Smoker or Former Smoker. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | 0.3 | ± 2.54 |
| Placebo | -0.12 | ± 1.55 |
Difference (12 month-baseline) in the sum of baseline target nodules diameters
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | 0.1 | ± 2.4 |
| Placebo | -0.1 | ± 1.1 |
Difference (12 month-baseline) in lesion volume
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | -4.5 | ± 78 |
| Placebo | -4.8 | ± 134 |
Difference (12 month-baseline) in lesion density
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | 24 | ± 65 |
| Placebo | 28 | ± 78 |
Difference (12 month-baseline) in biomarker concentration
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | -35.8 | ± 53.4 |
| Placebo | 20.5 | ± 50.7 |
Difference (12 month-baseline) in biomarker concentration
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | -60.7 | ± 210 |
| Placebo | 29.8 | ± 215 |
Difference (12 month-baseline) in biomarker concentration
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | -235 | ± 1240 |
| Placebo | -9 | ± 592 |
Difference (12 month-baseline) in biomarker concentration
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | -0.12 | ± 0.88 |
| Placebo | -0.08 | ± 0.5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Aspirin | 0.14 | ± 8.94 |
| Placebo | 0.36 | ± 7.36 |
Time frame: Baseline up to 13 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Aspirin | Placebo |
|---|---|---|---|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hemorrhoids | Gastrointestinal disorders | — | — |
| Balanitis | Infections and infestations | — | — |
| Increased volume of target lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Anal fissures | Surgical and medical procedures | — | — |
| Penile implant | Surgical and medical procedures | — | — |
| Reaction | System | Aspirin | Placebo |
|---|---|---|---|
| Bronchial infection | Infections and infestations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Flu-like symptoms | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Stomach pain | Gastrointestinal disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — | — |
| Cystitis noninfective | Renal and urinary disorders | — | — |
| Other | Surgical and medical procedures | — | — |
| Hypertension | Vascular disorders | — | — |
| Other | Infections and infestations | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Other | Eye disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Periodontal disease | Gastrointestinal disorders | — | — |
| Hemorroidal hemorrage | Gastrointestinal disorders | — | — |
| Gastrointestinal pain | Gastrointestinal disorders | — | — |
| Gastrointestinal disorder, other | Gastrointestinal disorders | — | — |
| Tooth infection | Infections and infestations | — | — |
| Otitis media | Infections and infestations | — | — |
| Bilirubin increased | Investigations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Renal colic | Renal and urinary disorders | — | — |
| Other | Reproductive system and breast disorders | — | — |
| Epistaxix | Respiratory, thoracic and mediastinal disorders | — | — |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | — | — |
| Other | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Lung cancer, Bladder cancer, Hemorrhoids, Balanitis, Increased volume of target lesion, Liposarcoma, Anal fissures, Penile implant.
Data from ClinicalTrials.gov NCT02169271 adverse events section.
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.
7 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02169271.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing