Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC
- Determine the therapeutic activity of neoadjuvant induction therapy comprising
gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung
cancer undergoing surgery.
- Determine the safety profile of this regimen in these patients.
- Determine the stage downsizing and complete resectability rate in patients with no
progressive disease who undergo surgery after treatment with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1, 8,
22, 29, 43, and 50; cisplatin IV over 3-6 hours on days 2, 23, and 44; and oral gefitinib
once daily on days 51-79. Treatment continues in the absence of disease progression or
unacceptable toxicity. Within 2-7 days after completion of induction therapy, patients with
no progressive disease undergo tumor resection.
After completion of study treatment, patients are followed at least every 3 months for 2
years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Complete response rate as measured by RECIST criteria prior to surgery
Nico Van Zandwijk, MD, PhD
The Netherlands Cancer Institute
United States: Federal Government