The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.
This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation,primary endpoint is progress-free survival,second endpoints include overall survival, time to progression, and so on.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
296
Icotinib: 125 mg is administered orally three times per day.
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
The First Affiliated Hospital of Anhui Medical Univercity
Hefei, Anhui, 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: 12 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: 20 months
Objective response rate
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Time frame: 12 weeks
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Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital for Chest Tumors & Tuberculosis Diseases
Beijing, Beijing Municipality, China
Xinqiao Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Hebei Provincal Tumor Hospital
Shijiazhuang, Hebei, China
Harbin Medical Univercity Cancer Hospital
Harbin, Heilongjiang, China
Henan Provincal Tumor Hospital
Zhengzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
...and 11 more locations