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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: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by OSI Pharmaceuticals.
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 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,252 participants |
| Start Date | 2006-09 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00373425 record still lists
NCT00373425 is an interventional study that assigns participants to a tested intervention. Its 1,252 participants enrollment target places it among the larger protocols in the corpus, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT00373425's enrollment target sits among peer trials
1,252 17th of 454 higher than 438 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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