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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00373425

Run by

OSI Pharmaceuticals

People needed

1252

Starts

2006-09-01

Expected to finish

2014-06-01

Last updated by the study team

2015-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• University of Arkansas for Medical Science — Little Rock, Arkansas, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope Nat'l Medical Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• USC/ Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• University of California, San Francisco Comprehensive Cancer Center — San Francisco, California, United States
• City of Hope Medical Group (COHMG) — South Pasadena, California, United States
• Rocky Mountain Cancer Center- Aurora — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• Penrose St. Francis Health Services — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center-Midtown — Denver, Colorado, United States
• Rocky Mountain Cancer Centers- Rose — Denver, Colorado, United States
• Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
• Rocky Mountain Cancer Centers-Littleton — Littleton, Colorado, United States
• Rocky Mountain Cancer Center-Sky Ridge — Lone Tree, Colorado, United States
• Rocky Mountain Cancer Centers-Longmont — Longmont, Colorado, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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