Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).

Treatment with placebo po QD appearing identical to enzastaurin.

Enzastaurin

Placebo

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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.

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

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.

Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Eli Lilly and Company

Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).

Total

Age, Continuous

Sex: Female, Male

Caucasian

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Absence

Presence

Evidence of airway obstruction present if Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC ratio) ≤0.7; evidence of airway obstruction absent if FEV1/FVC ratio \>0.7.

Evidence of Airway Obstruction

Grade 0

Grade 1

Measure of performance status as defined by ECOG on a scale of Grade 0 to Grade 5: 0=Fully active, able to carry on pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light and sedentary work; 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.

Eastern Cooperative Oncology Group (ECOG)

Participants were asked if they have a history of Stage 1 (cancer is small and has not spread to the lymph nodes) Non-small Cell Lung Cancer.

History of Stage I Non-small Cell Lung Cancer

The planned enrollment for the study was 186 participants, but enrollment was terminated early due to the difficulty of accruing participants once 40 were enrolled into the study.

Chief Medical Officer

The number of participants analyzed was based on the efficacy population (EP). The EP included participants who met study criteria, were randomized to the study, and who had Ki-67 measurements from biopsy specimens.

Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint

SAEs

Other Non-Serious AEs

The number of participants analyzed was based on the safety population (SP). The SP included participants who received at least 1 dose of enzastaurin or placebo during the study.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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