NCT00049543

Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery

A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies how well gefitinib works in treating patients with stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors from returning after they have been removed by surgery.

Detailed description

PRIMARY OBJECTIVES: I. To assess, in comparison with placebo, the impact of adjuvant therapy with two years of daily oral ZD1839 (IRESSA) (gefitinib) on the overall survival of patients with completely resected (T1N1-2, T2N0-2, T3N0-2) non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To compare the disease-free survival in the placebo arm to the ZD1839 (IRESSA) arm. II. To confirm the prognostic significance of epidermal growth factor receptor (EGFR) expression, phosphorylation and mutations when present in the primary tumor. III. To assess the ability of EGFR expression, phosphorylation and mutations in the primary tumor to predict the relative impact of ZD1839 (IRESSA) on survival. IV. To establish a comprehensive tumour bank linked to a clinical database for the further study of molecular markers in resected NSCLC. V. To further evaluate toxicity related to ZD1839 (IRESSA). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gefitinib orally (PO) once daily (QD) for 2 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 6 months, every 6 months for 3 years, and then annually thereafter.

Conditions

• Adenocarcinoma of the Lung
• Adenosquamous Cell Lung Cancer
• Bronchoalveolar Cell Lung Cancer
• Large Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer
• Stage IIA Non-small Cell Lung Cancer
• Stage IIB Non-small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	gefitinib	Given PO
OTHER	placebo	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2003-01-27
• Last updated: 2015-01-01
• Results posted: 2015-01-01

Locations

1 site across 1 country: Canada