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

COMPLETED 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

NCT00373425 · View on ClinicalTrials.gov ↗

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

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00373425

The ClinicalTrials.gov registry entry for NCT00373425 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OSI Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00373425 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00373425?

The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00373425?

This trial is sponsored by OSI Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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