Lung Cancer Clinical Trial
Official title:
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
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is
effective in delaying the recurrence of non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works
compared to placebo in delaying tumor recurrence in patients who have undergone initial
chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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