---
title: A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
nct_id: NCT00414960
overall_status: COMPLETED
phase: PHASE2
sponsor: Eli Lilly and Company
study_type: INTERVENTIONAL
primary_condition: Lung Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00414960.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00414960"
ct_last_update_post_date: 2020-09-21
last_seen_at: "2026-05-12T06:56:02.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers

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

**NCT ID:** [NCT00414960](https://clinicaltrials.gov/study/NCT00414960)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Eli Lilly and Company
- **Conditions:** Lung Cancer
- **Start Date:** 2007-12
- **Completion Date:** 2010-09
- **CT.gov Last Update:** 2020-09-21

## Brief Summary

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.

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Enzastaurin** (EXPERIMENTAL) — Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).
- **Placebo** (PLACEBO_COMPARATOR) — Treatment with placebo po QD appearing identical to enzastaurin.

## Interventions

- **Enzastaurin** (DRUG) — 500 mg po QD for 6 months
- **Placebo** (DRUG) — po QD for 6 months

## Primary Outcomes

- **Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint** _(time frame: Baseline, endpoint (up to 8 months))_ — 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.

## Secondary Outcomes

- **Number of Participants With Adverse Events (AEs)** _(time frame: Baseline through end of study (up to 32 months))_

## 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

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.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` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00414960.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00414960*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*