This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Hunan Province Tumor Hospital
Changsha, Hunan, China
ACTIVE_NOT_RECRUITINGSir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
ACTIVE_NOT_RECRUITINGThe First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
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.
Time frame: 6 months
Overall survival
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Time frame: 12 months
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
ACTIVE_NOT_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
ACTIVE_NOT_RECRUITING