A Phase Ⅱ Randomized Controlled Trial to Compare Gefitinib With Docetaxel as Second-line Therapy for Advanced or Metastatic Non-squamous NSCLC Patients With Wild-type EGFR
The adoption of docetaxel as a standard second line therapy was based on data from two phase
Ⅲ trials. In the first trail, docetaxel (75mg/m2, every 3 weeks) significantly prolonged
median and 1-year survival duration compared with best supportive care (median survival, 7.5
months versus 4.6 months; P=0.010; 1-year survival, 37% versus 12%), although the response
rate was low (5.5%). In the second study the 6-months and median survival rates were similar
for docetaxel and vinorelbine or ifosfamide. However, the 1-year survival rate was
significantly greater with docetaxel than ifosfamide or vinorelbine (32% versus 19%,
P=0.025). In both studies docetaxel significantly improved some parameters of quality of
life. Since these two pivotal studies, new potential second-line drugs were compared with
the docetaxel standard of care. With regards to the therapeutic results of the docetaxel arm
of these studies, it must be emphasized that response rates and survival data were highly
and significantly reproducible.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
up to 52 weeks (about one year)
No
Mengzhao Wang, MD
Principal Investigator
Peking Union Medical College Hospital
China: Food and Drug Administration
PUMCH-S466
NCT01755923
December 2012
December 2014
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