NCT00373425

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00373425

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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 With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

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.

Eligibility

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.

Disease(s) and\or Condition(s)

Non-small Cell Lung Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Erlotinib
- Description: 150 mg tablet
- Arm Group Labels: Erlotinib
- Type: DRUG
- Name: Placebo
- Description: Placebo tablet
- Arm Group Labels: Placebo

Sponsor

OSI Pharmaceuticals