The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia) combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) , disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.
Recombinant endostatin injection Sulijia is a new type of recombinant protein drugs inhibiting tumor angiogenesis developed by a group of Chinese scientists and clinician. It is expressed in E. coli which Consists of 184 amino acids. It appears to be better than NP chemotherapy alone in terms of efficacy in phase I/II trials for advanced NSCLC. In this study, a randomized, double-blind, Placebo plus NP as control, multi-center phase III trial was designed to evaluate the safety and efficacy of Sulijia plus NP in the treatment of advanced NSCLC patients. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), DCR (disease control rate) and safety as the secondary end-point. A total of 560 patients have been recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
560
Drug 1: Placebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle(stop interventing until the disease progress) Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)
Drug 1: Sulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle(stop interventing until the disease progress) Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)
Progression Free Survival(PFS)
A duration from date of randomization until the date of first documented progression (as defined by RECIST 1.1) or date of death from any cause, whichever came first. A participant will be censored at the last date they are known not to be progressed.
Time frame: Assessed up to 24 months
Objective response rate(ORR)
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) (as defined by RECIST 1.1).
Time frame: Assessed up to 24 months
Disease control rate(DCR)
Disease Control Rate is defined as the proportion of patients with complete response(CR), partial response(PR), or stable disease(SD) (as defined by RECIST 1.1).
Time frame: Assessed up to 24 months
Overall survival(OS)
Overall Survival is assessed via calculation of the time to death due to any cause. A participant will be censored at the last date they are known to be alive.
Time frame: Assessed up to 72 months
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Bengbu medical college affiliated hospital
Bengbu, Anhui, China
The first affiliated hospital, anhui medical university
Hefei, Anhui, China
The second affiliated hospital, anhui medical university
Hefei, Anhui, China
Beijing Chest Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou Medical School
Shantou, Guangdong, China
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