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.
Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3 week cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
gefitinib 250mg tablet/ QD daily until Progression
gemcitabine(1250mg/m2 iv on D1 \& 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles
National Cancer Center, Korea
Goyang-si, Gyenggi-do, South Korea
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
overall survival
Time frame: every 12 weeks
To compare Progression-Free survival
Time frame: every 9 weeks
To compare the quality of life
Time frame: every 3 weeks
To compare safety profile
Time frame: every 9 weeks
To collect the tissue samples for the study of predictors of gefitinib (optional)
Time frame: screening period
To compare the objective response rate (CR+PR)
Time frame: from the date of randomization to the date of death from any cause the result of each should be recorded separately
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.