Phase Ⅱ Study of Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation
Patients with stage IV NSCLC who have exon21 mutation will randomized to received oral
erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable
toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation
status of exons 18-21. The response will be evaluated by RECIST criteria first month,second
month and then repeat every 3 months after the beginning of the treatment weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate
2011-07
No
Wu Yi Long, MD
Principal Investigator
Guangdong General Hospital
United States: Food and Drug Administration
C-TONG0901
NCT01024413
July 2009
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