Skip to main content
OpenTrials
Completed

NCT Number: NCT03117335

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bengbu medical college affiliated hospital, Bengbu, Anhui, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebos

Drug

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

Sulijia

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Apr 17, 2017
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.