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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride

Criteria

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.