First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
The investigators will conduct the randomized trial to determine the role of Gefitinib
monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as
compared with the standard combination chemotherapy.
This is a randomized, open label, parallel group, phase III study in never-smokers with
advanced or metastatic adenocarcinoma of lung.
After stratification by gender, performance status, and disease stage, patients will be
randomized to one of the two treatment arms to receive either gefitinib or standard
chemotherapy until clinical or objective disease progression, unacceptable toxicity or
patient's refusal, whichever is sooner. The chemotherapy will be administered for no more
than nine cycles.