An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of
icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb
and IV) NSCLC and mutated EGFR.
- Primary endpoint to assess progression-free survival
- Secondary endpoints to assess the overall survival, objective response rate, disease
control rate and so on.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
12 months
No
Han Baohui, MD
Principal Investigator
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
China: Food and Drug Administration
BD-IC-IV20
NCT01646450
July 2012
December 2013
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