Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer

Advanced Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117335
• Other study ID #: TG1107RHE
• Secondary ID: BA2010071
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2017
• Last updated: April 12, 2017
• Start date: November 10, 2011
• Est. completion date: January 17, 2017

Study information

• Verified date: April 2017
• Source: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: January 17, 2017
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Placebos
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)
• Sulijia
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)

Locations

Country	Name	City	State
China	Beijing Chest Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Bengbu medical college affiliated hospital	Bengbu	Anhui
China	Binzhou medical school affiliated hospital	Binzhou	Shandong
China	The First Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The first People's Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital ,Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	Guilin medical college affiliated hospital	Guilin	Guangxi
China	Zhejiang cancer hospital	Hangzhou	Zhejiang
China	The first affiliated hospital, anhui medical university	Hefei	Anhui
China	The second affiliated hospital, anhui medical university	Hefei	Anhui
China	Jinan Central Hospital Affiliated of Shandong University	Jinan	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	The People 's Liberation Army Eighth Hospital	Nanjing	Jiangsu
China	Affiliate Hospital of Nantong University	Nantong	Jiangsu
China	Shanghai General Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou Medical School	Shantou	Guangdong
China	The tumor hospital of liaoning province	Shenyang	Liaoning
China	People's hospital SiPingShi center	Siping	Jilin
China	The first hospital affiliated to suzhou university	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Oncology Center of Wuhan Union Hospital	Wuhan	Hubei
China	Zhongnan hospital of Wuhan University	Wuhan	Hubei
China	The Fourth People's Hospital of Wuxi	Wuxi	Jiangsu
China	First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The first affiliated hospital of xinxiang medical college	Xinxiang	Henan
China	Xuzhou medical college affiliated hospital	Xuzhou	Jiangsu
China	Yanbian university hospital	Yanji	Jilin
China	The second people's hospital of yibin city	Yibin	Sichuan
China	Ningxia medical university general hospital	Yinchuan	Ningxia
China	Yueyang city people's hospital	Yueyang	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed up to 24 months
Secondary	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).	Assessed up to 24 months
Secondary	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).	Assessed up to 24 months
Secondary	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.	Assessed up to 72 months