An Open ,Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
This is a multi-center phase II randomized controlled study to assess the safety and
efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with
non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS,
as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Zhang Yi Ping, M.D.
Zhejiang Cancer Hospital
China: Food and Drug Administration