This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
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: 15 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: 24 months
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 15 months
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
First Hospital of Lanzhou University
Lanzhou, Gansu, China
ACTIVE_NOT_RECRUITINGLanzhou military region general hospital
Lanzhou, Gansu, China
ACTIVE_NOT_RECRUITINGGeneral Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGCancer Hospital of Sun Yat-sen
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGFirst Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGJiangmen central hospital
Jiangmen, Guangdong, China
ACTIVE_NOT_RECRUITINGThe university of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
ACTIVE_NOT_RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
ACTIVE_NOT_RECRUITINGMedical Oncology,Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
ACTIVE_NOT_RECRUITINGThoracic Surgery,Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
ACTIVE_NOT_RECRUITING...and 21 more locations