Clinical trial · Interventional
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
NCT00414960CI-TRIAL-00047247completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzastaurin | Drug | Enzastaurin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzastaurin
- description
- Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each).
- interventionNames
- Drug: Enzastaurin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Treatment with placebo po QD appearing identical to enzastaurin.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
- timeFrame
- Baseline, endpoint (up to 8 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.