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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Enzastaurin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzastaurin<br>Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each). | Drug: Enzastaurin<br>* 500 mg po QD for 6 months<br>* Other names: LY317615;|
| Placebo Comparator: Placebo<br>Treatment with placebo po QD appearing identical to enzastaurin. | Drug: Placebo<br>* po QD for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint | The number of cells positively stained for Ki-67 (a marker of cellular proliferation) was enumerated and divided by the total number of cells in each specimen. The average Ki-67 labeling index (LI) (percentage of cells positively labeled with Ki-67) for all histological specimens was then calculated for each participant. | Baseline, endpoint (up to 8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Baseline through end of study (up to 32 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Prevention