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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- OSI Pharmaceuticals
- Interventions being studied
- Drug: Erlotinib; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.