Clinical trial NCT03117335: Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
Official title: Recombinant Endostatin With Vinorelbine and Cisplatin (NP) Plus Maintenance Therapy With Recombinant Endostatin for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Sulijia
Recombinant endostatin
Vinorelbine
Cisplatin
Lead sponsor: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2017-04-17
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female aged 18 to 70 years old;
2. Patients with histological confirmed stage IV NSCLC;
3. According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter \>=10mm by spiral CT, PET-CT, with the largest diameter \>=20mm by ordinary CT and MRI;
4. general condition ECOG performance scale (PS) 0-1;
5. Life expectancy of more than 3 months;
6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \> 1.5\*10\^9/L, platelet count\> 90\*10\^9/L, hemoglobin\> 9g/dL; liver function: serum bilirubin was less than 2\* maximum normal value; ALT and AST were less than 2.5\*maximum normal value; BUN, Cr within 80% of normal range;
7. Patients could understand the circumstances of this study and those who have signed the informed consent form.

Exclusion Criteria:

1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time;
2. Patients who have uncontrolled brain metastasis;
3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;
4. Pregnant or lactating women;
5. Severe infected patients;
6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;
7. Patients who have vein thrombus;
8. Patients who have psychiatric illness;
9. Patients who are allergic to E. coli preparation;
10. Researchers believe that those who do not fit.

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: Assessed up to 24 months
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: Assessed up to 24 months
measure: Disease control rate(DCR)
timeFrame: Assessed up to 24 months
measure: Overall survival(OS)
timeFrame: Assessed up to 72 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Bengbu medical college affiliated hospital
state: Anhui
city: Hefei
country: China
facility: The first affiliated hospital, anhui medical university
state: Anhui
city: Hefei
country: China
facility: The second affiliated hospital, anhui medical university
state: Anhui
city: Beijing
country: China
facility: Beijing Chest Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou Medical School
state: Guangdong
city: Guilin
country: China
facility: Guilin medical college affiliated hospital
state: Guangxi
city: Xinxiang
country: China
facility: The first affiliated hospital of xinxiang medical college
state: Henan
city: Wuhan
country: China
facility: The Oncology Center of Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Yueyang
country: China
facility: Yueyang city people's hospital
state: Hunan
city: Changzhou
country: China
facility: The first People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The People 's Liberation Army Eighth Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliate Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: The first hospital affiliated to suzhou university
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: The Fourth People's Hospital of Wuxi
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou medical college affiliated hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Siping
country: China
facility: People's hospital SiPingShi center
state: Jilin
city: Yanji
country: China
facility: Yanbian university hospital
state: Jilin
city: Shenyang
country: China
facility: The tumor hospital of liaoning province
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia medical university general hospital
state: Ningxia
city: Binzhou
country: China
facility: Binzhou medical school affiliated hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated of Shandong University
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital ,Sichuan University
state: Sichuan
city: Yibin
country: China
facility: The second people's hospital of yibin city
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Cancer Hospital Chinese Academy of Medical Science
name: Yuankai Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: