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A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients Wi

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Trial Conditions
  • Non-Small Cell Lung Cancer
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


18 and older



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.

Gender: Both
Steward Physician(s)
  • Medical Monitor
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
  • Erlotinib
  • Placebo
Physician Researcher

Investigator Name:

  • Medical Monitor

Other Information

Sponsor: OSI Pharmaceuticals
Phase: Phase 3
Trial ID: NCT00373425
Volunteers:  Not Accepting Healthy Volunteers

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