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

April 12, 2017 updated by: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival(PFS)
Time Frame: Assessed up to 24 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: Assessed up to 24 months
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)
Time Frame: Assessed up to 24 months
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)
Time Frame: Assessed up to 72 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tigermed Consulting Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuankai Shi, M.D., Cancer Hospital Chinese Academy of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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