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

Eli Lilly and Company40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Lung Cancer

Interventions

EnzastaurinDRUG

500 mg po QD for 6 months

PlaceboDRUG

po QD for 6 months

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, endpoint (up to 8 months)

Secondary Outcomes

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.

Time frame: Baseline through end of study (up to 32 months)

Data from ClinicalTrials.gov

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