A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV
HER2-overexpressing non-small cell lung cancer.
I. Determine the duration of response in patients treated with this regimen. II. Determine
the toxicity of this treatment regimen in this patient population.
III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient
V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues
once a week in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression or death.
PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study
within 17.5 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response [CR] and partial response [PR])
Up to 5 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
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