EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients. In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.
EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, . Even Chinese and Japanese are classified as Asian based on location, the figure of Chinese is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Chinese is much higher than Western countries. Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients. In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Gefitinib 250mg Thalidomide 200 MG
Fujian Cancer Hospital Radiation Oncology Department
Fuzhou, Fujian, China
RECRUITINGFujian cancer hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGPFS
progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months
ORR
Overall Response Rate
Time frame: through study completion, and average of 2 years
OS
Overall Survival
Time frame: From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months
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