Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
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
2 other identifiers
interventional
560
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2017
CompletedFirst Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedApril 17, 2017
April 1, 2017
5 years
April 10, 2017
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Objective response rate(ORR)
Assessed up to 24 months
Disease control rate(DCR)
Assessed up to 24 months
Overall survival(OS)
Assessed up to 72 months
Study Arms (2)
Vinorelbine plus Cisplatin With placebos
ACTIVE COMPARATORThe control group
Vinorelbine plus Cisplatin With Sulijia
EXPERIMENTALThe treatment group
Interventions
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)
Eligibility Criteria
You may qualify if:
- Male and female aged 18 to 70 years old;
- Patients with histological confirmed stage IV NSCLC;
- 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;
- general condition ECOG performance scale (PS) 0-1;
- Life expectancy of more than 3 months;
- 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;
- Patients could understand the circumstances of this study and those who have signed the informed consent form.
You may not qualify if:
- Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time;
- Patients who have uncontrolled brain metastasis;
- Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer;
- Pregnant or lactating women;
- Severe infected patients;
- Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure;
- Patients who have vein thrombus;
- Patients who have psychiatric illness;
- Patients who are allergic to E. coli preparation;
- Researchers believe that those who do not fit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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
Guilin medical college affiliated hospital
Guilin, Guangxi, China
The first affiliated hospital of xinxiang medical college
Xinxiang, Henan, China
The Oncology Center of Wuhan Union Hospital
Wuhan, Hubei, China
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Yueyang city people's hospital
Yueyang, Hunan, China
The first People's Hospital of Changzhou
Changzhou, Jiangsu, 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
The first hospital affiliated to suzhou university
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Xuzhou medical college affiliated hospital
Xuzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
People's hospital SiPingShi center
Siping, Jilin, China
Yanbian university hospital
Yanji, Jilin, China
The tumor hospital of liaoning province
Shenyang, Liaoning, China
Ningxia medical university general hospital
Yinchuan, Ningxia, China
Binzhou medical school affiliated hospital
Binzhou, Shandong, China
Jinan Central Hospital Affiliated of Shandong University
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
West China Hospital ,Sichuan University
Chengdu, Sichuan, China
The second people's hospital of yibin city
Yibin, Sichuan, China
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuankai Shi, M.D.
Cancer Hospital Chinese Academy of Medical Science
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 17, 2017
Study Start
November 10, 2011
Primary Completion
November 14, 2016
Study Completion
January 17, 2017
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share