Clinical trial · Interventional
Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Randomized, Phase IIb Trial of Sulindac in Smokers With Bronchial Dysplasia
NCT00368927CI-TRIAL-00014679completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
| Stage I Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| sulindac | Drug | Sulindac | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral sulindac twice daily for 6 months.
- interventionNames
- Drug: sulindac
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo twice daily for 6 months.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
- timeFrame
- Baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria:
* Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
* No prior lung cancer
* Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
* Tissue blocks, blood, and sputum samples available for research purposes
* No carcinoma in situ
* ECOG performance status 0-1
* Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
* Room air oxygen saturation ≥ 90%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Negative chest x-ray
* Negative electrocardiogram
* No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer
* Treatment must have been completed \> 6 months ago
* No prior gastrointestinal ulceration, bleeding, or perforation
* No uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Myocardial infarction within the past 6 months
* Chronic renal disease
* Chronic liver disease
* Difficult to control hypertension
* Psychiatric illness or social situations that would limit study compliance
* No known HIV positivity
* No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
* No known sensitivity to yellow dye FD\&C Yellow #5
* No continuous or intermittent supplemental oxygen
* At least 6 months since prior participation in another chemoprevention trial
* At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
* No prior pneumonectomy
* No prior solid organ transplantation
* No other concurrent investigational agents
* No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention
* Maximum of 1 aspirin (81 mg) per day allowed
* No concurrent use of any of the following:
* Methotrexate
* Corticosteroids
* Antiplatelet agents:
* Warfarin
* Ticlopidine
* Clopidogrel bisulfate
* Aspirin
* Abciximab
* Dipyridamole
* Eptifibatide
* Tirofiban hydrochloride
* Lithium carbonate
* Cyclosporine
* Hydralazine
* Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed)
* Angiotensin receptor blockersReferences
Publications (1)
- DERIVEDLimburg PJ, Mandrekar SJ, Aubry MC, Ziegler KL, Zhang J, Yi JE, Henry M, Tazelaar HD, Lam S, McWilliams A, Midthun DE, Edell ES, Rickman OB, Mazzone P, Tockman M, Beamis JF, Lamb C, Simoff M, Loprinzi C, Szabo E, Jett J; Cancer Prevention Network. Randomized phase II trial of sulindac for lung cancer chemoprevention. Lung Cancer. 2013 Mar;79(3):254-61. doi: 10.1016/j.lungcan.2012.11.011. Epub 2012 Dec 20. PMID 23261228