Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00368927 · ClinicalTrials.gov registry record · Phase 2

Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT00368927: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00368927 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist → Add completion date to calendar (.ics) →

The verdict

NCT00368927, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.

Primary Outcome

Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial respon

Interventions

  • OTHER placebo
  • DRUG sulindac

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2006-08
Est. Completion 2010-12
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00368927 record still lists

NCT00368927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00368927 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00368927 about?

NCT00368927 is a clinical study titled "Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia". This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac ma...

What is the current status of trial NCT00368927?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2006-08. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00368927?

The interventions under investigation include: placebo (OTHER), sulindac (DRUG).

Who is sponsoring clinical trial NCT00368927?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00368927's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04115306 · 61 participants · Phase 1

    Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

  • NCT05070845 · 61 participants · Phase 2

    Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

  • NCT05187832 · 61 participants · Phase 1

    A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

  • NCT05269316 · 61 participants · Phase 1

    Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00368927, the US trial registry maintained by the National Library of Medicine. NCT00368927 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.