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NCT00373425 · ClinicalTrials.gov registry record · Phase 3

A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors

A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by OSI Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,252
Enrollment target
20
Study locations

NCT00373425 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 1,252 participants, above the 656-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00373425, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by OSI Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,252 participants
Enrollment target
20
Study locations

Study Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Erlotinib

Study Locations (20)

California

  • Tower Cancer Research Foundation - Beverly Hills
  • City of Hope Nat'l Medical Center - Duarte
  • Loma Linda University Medical Center - Loma Linda
  • USC/ Norris Comprehensive Cancer Center - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Comprehensive Cancer Center at Desert Regional Medical Center - Palm Springs
  • Bay Area Cancer Research Group, LLC - Pleasant Hill
  • University of California, San Francisco Comprehensive Cancer Center - San Francisco
  • City of Hope Medical Group (COHMG) - South Pasadena

Colorado

  • Rocky Mountain Cancer Center- Aurora - Aurora
  • University of Colorado Hospital - Aurora
  • Rocky Mountain Cancer Centers-Boulder - Boulder
  • Penrose St. Francis Health Services - Colorado Springs
  • Rocky Mountain Cancer Center - Colorado Springs
  • Rocky Mountain Cancer Center - Colorado Springs
  • Rocky Mountain Cancer Center-Midtown - Denver

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Arizona Cancer Center - Tucson

Arkansas

  • University of Arkansas for Medical Science - Little Rock

Trial Details

FieldValue
Enrollment Target 1,252 participants
Start Date 2006-09
Est. Completion 2014-06
Phase Phase 3

Sponsor

OSI Pharmaceuticals

16 total trials

What the Registry Record Tells You About NCT00373425

The ClinicalTrials.gov registry entry for NCT00373425 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,252 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 656-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% higher). The listed sponsor is OSI Pharmaceuticals, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00373425 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Alabama.

Frequently Asked Questions

What is clinical trial NCT00373425 about?

NCT00373425 is a clinical study titled "A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors". This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

What is the current status of trial NCT00373425?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,252 participants. The study started on 2006-09. Estimated completion is 2014-06.

What conditions does trial NCT00373425 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00373425?

The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG).

Who is sponsoring clinical trial NCT00373425?

This trial is sponsored by OSI Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00373425 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.