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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Placebos; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 560
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vinorelbine plus Cisplatin With placebos; The control group	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); Other Names: Sodium Chloride Injection
Experimental: Vinorelbine plus Cisplatin With Sulijia; The treatment group	Drug: 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); Other Names: Recombinant endostatin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
• Collaborators: Tigermed Consulting Co., Ltd
• Investigators: Principal Investigator: Yuankai Shi, M.D., Cancer Hospital Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2011
• Primary Completion (Actual): November 14, 2016
• Study Completion (Actual): January 17, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Cisplatin; Vinorelbine; Non-small Cell Lung Cancer; Sulijia; Recombinant endostatin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostatins
• Other Study ID Numbers: TG1107RHE; BA2010071 (Other Grant/Funding Number: Science and Technology Department of Jiangsu Province)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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