CompletedPhase 3NCT00373425

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.

Checked against the public recordLast updated Sep 17, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations295
SponsorOSI Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
OSI Pharmaceuticals
Interventions being studied
Drug: Erlotinib; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests * Patients may have up to 4 cycles of chemotherapy after surgery * Complete removal of the tumor by surgery * Able to start drug under the following timelines: * 6 months from the day of surgery for patients who get chemotherapy * 3 months from the day of surgery for those who do not get chemotherapy * Confirmed diagnosis of Stage IB-IIIA NSCLC * Patients must be accessible for follow-up visits Exclusion Criteria: * History of prior radiotherapy for NSCLC either before or after surgery * History of heart disease or uncontrolled heart arrhythmias within the previous year * History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug * History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years * Patients who have received chemotherapy for NSCLC before surgery * Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • Arizona Cancer CenterTucson, Arizona
  • University of Arkansas for Medical ScienceLittle Rock, Arkansas
  • Tower Cancer Research FoundationBeverly Hills, California
  • City of Hope Nat'l Medical CenterDuarte, California
  • Loma Linda University Medical CenterLoma Linda, California
  • USC/ Norris Comprehensive Cancer CenterLos Angeles, California
  • Cedars-Sinai Medical CenterLos Angeles, California
  • Hoag Memorial Hospital PresbyterianNewport Beach, California
  • Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California
  • Bay Area Cancer Research Group, LLCPleasant Hill, California
  • University of California, San Francisco Comprehensive Cancer CenterSan Francisco, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2015. Always confirm current availability with the study team.

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