A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers

Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers

To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.

Inclusion Criteria:

• Sputum atypia participants with normal sputum cytology will be removed from the study)
• Metaplasia or dysplasia on at least one bronchoscopy specimen
• History of cigarette smoking ≥30 Pack Years
• Quit smoking ≥1 year prior to study entry
• Able to undergo bronchoscopy and helical computed tomography (CT) scanning of the chest
• Able to swallow tablets

Exclusion Criteria:

• Blood clotting abnormalities
• Current smoking within the past 1 year
• Unwillingness to abstain from smoking while enrolled in the clinical trial or unwillingness to avoid significant second hand smoke exposure
• Evidence for lung cancer or carcinoma in situ
• Active cardiovascular disease
• Current illicit drug or alcohol abuse