Clinical trial NCT00368927 (phase 2, status: completed)
Conditions: precancerous condition, stage i non-small cell lung cancer, tobacco use disorder
ICD codes: Y95, D69.9, J94.9, L53.9, G47.01, G47.14, P28.9, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, Z72.0, P04.2
Drugs: sulindac
SMILES: CC1=C(CC(O)=O)C2=CC(F)=CC=C2\C1=C/C1=CC=C(C=C1)S(C)=O
Eligibility criteria:

        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 blockers