A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
- Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer
that did not progress on prior first-line palliative induction chemotherapy when
treated with adjuvant gefitinib vs placebo.
- Compare progression-free survival of patients treated with these regimens.
- Determine the safety and toxicity of gefitinib in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to initial disease stage (IIIB vs IV), WHO performance status at
the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient
response to prior first-line palliative induction chemotherapy (objective response vs stable
disease), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this
study within 8.5 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Jan P. Van Meerbeeck, MD, PhD
Universitair Ziekenhuis Gent
United States: Federal Government