The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, China
Progression-Free Survival (PFS)
PFS is measured from the start of treatment until progression or death,whichever is first met
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks
Progression-Free Survival Rate at 6 Months (6-M-PFS)
6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month
Time frame: 6 months
Object Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks
Duration of Response (DOR)
DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met
Time frame: From the first date of response until the date of first documented progression, assessed up to 70 weeks
Overall Survival (OS)
OS is measured from the start of treatment until death
Time frame: From date of randomization until the date of death from any cause, followed for up to 76 weeks
Time To Progression (TTP) during the maintenance therapy period
TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met
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Given orally
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Time frame: From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks