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

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebos
Sulijia
Sponsored by
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Sulijia, Recombinant endostatin, Vinorelbine, Cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bengbu medical college affiliated hospital
  • The first affiliated hospital, anhui medical university
  • The second affiliated hospital, anhui medical university
  • Beijing Chest Hospital
  • Cancer Hospital Chinese Academy of Medical Science
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Xiamen University
  • The First Affiliated Hospital of Guangzhou Medical College
  • The First Affiliated Hospital of Shantou Medical School
  • Guilin medical college affiliated hospital
  • The first affiliated hospital of xinxiang medical college
  • The Oncology Center of Wuhan Union Hospital
  • Zhongnan hospital of Wuhan University
  • Changsha Central Hospital
  • The Second Xiangya Hospital of Central South University
  • Yueyang city people's hospital
  • The first People's Hospital of Changzhou
  • Jiangsu Cancer Hospital
  • The People 's Liberation Army Eighth Hospital
  • Affiliate Hospital of Nantong University
  • The first hospital affiliated to suzhou university
  • The Second Affiliated Hospital of Soochow University
  • The Fourth People's Hospital of Wuxi
  • Xuzhou medical college affiliated hospital
  • The First Hospital of Jilin University
  • People's hospital SiPingShi center
  • Yanbian university hospital
  • The tumor hospital of liaoning province
  • Ningxia medical university general hospital
  • Binzhou medical school affiliated hospital
  • Jinan Central Hospital Affiliated of Shandong University
  • Linyi Cancer Hospital
  • Shanghai General Hospital
  • West China Hospital ,Sichuan University
  • The second people's hospital of yibin city
  • Zhejiang cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vinorelbine plus Cisplatin With placebos

Vinorelbine plus Cisplatin With Sulijia

Arm Description

The control group

The treatment group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
April 10, 2017
Last Updated
April 12, 2017
Sponsor
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03117335
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 10, 2011 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer, Sulijia, Recombinant endostatin, Vinorelbine, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vinorelbine plus Cisplatin With placebos
Arm Type
Active Comparator
Arm Description
The control group
Arm Title
Vinorelbine plus Cisplatin With Sulijia
Arm Type
Experimental
Arm Description
The treatment group
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Sodium Chloride Injection
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Sulijia
Other Intervention Name(s)
Recombinant endostatin injection
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Description
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
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
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
Title
Disease control rate(DCR)
Description
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
Title
Overall survival(OS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, M.D.
Organizational Affiliation
Cancer Hospital Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bengbu medical college affiliated hospital
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
The first affiliated hospital, anhui medical university
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The second affiliated hospital, anhui medical university
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Chest Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Shantou Medical School
City
Shantou
State/Province
Guangdong
Country
China
Facility Name
Guilin medical college affiliated hospital
City
Guilin
State/Province
Guangxi
Country
China
Facility Name
The first affiliated hospital of xinxiang medical college
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
The Oncology Center of Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Zhongnan hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Yueyang city people's hospital
City
Yueyang
State/Province
Hunan
Country
China
Facility Name
The first People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The People 's Liberation Army Eighth Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliate Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
The first hospital affiliated to suzhou university
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Fourth People's Hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Xuzhou medical college affiliated hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
People's hospital SiPingShi center
City
Siping
State/Province
Jilin
Country
China
Facility Name
Yanbian university hospital
City
Yanji
State/Province
Jilin
Country
China
Facility Name
The tumor hospital of liaoning province
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Ningxia medical university general hospital
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Binzhou medical school affiliated hospital
City
Binzhou
State/Province
Shandong
Country
China
Facility Name
Jinan Central Hospital Affiliated of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital ,Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The second people's hospital of yibin city
City
Yibin
State/Province
Sichuan
Country
China
Facility Name
Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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