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Advanced Non-small Cell Lung CancerPhase 3NCT03117335

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

A Phase 3 study testing Sulijia in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. at 37 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
Sulijia
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
560 participants
Where
37 sitesChina
Study dates
10 Nov 2011to 17 Jan 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Beijing Chest Hospital

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Bengbu medical college affiliated hospital

    Bengbu, Anhui

  • Binzhou medical school affiliated hospital

    Binzhou, Shandong

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Changsha Central Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The first People's Hospital of Changzhou

    Changzhou, Jiangsu

  • West China Hospital ,Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong

  • Guilin medical college affiliated hospital

    Guilin, Guangxi

  • Zhejiang cancer hospital

    Hangzhou, Zhejiang

  • The first affiliated hospital, anhui medical university

    Hefei, Anhui

  • The second affiliated hospital, anhui medical university

    Hefei, Anhui

  • Jinan Central Hospital Affiliated of Shandong University

    Jinan, Shandong

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • The People 's Liberation Army Eighth Hospital

    Nanjing, Jiangsu

  • Affiliate Hospital of Nantong University

    Nantong, Jiangsu

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • The First Affiliated Hospital of Shantou Medical School

    Shantou, Guangdong

  • The tumor hospital of liaoning province

    Shenyang, Liaoning

  • People's hospital SiPingShi center

    Siping, Jilin

  • The first hospital affiliated to suzhou university

    Suzhou, Jiangsu

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • The Oncology Center of Wuhan Union Hospital

    Wuhan, Hubei

  • Zhongnan hospital of Wuhan University

    Wuhan, Hubei

  • The Fourth People's Hospital of Wuxi

    Wuxi, Jiangsu

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The first affiliated hospital of xinxiang medical college

    Xinxiang, Henan

  • Xuzhou medical college affiliated hospital

    Xuzhou, Jiangsu

  • Yanbian university hospital

    Yanji, Jilin

  • The second people's hospital of yibin city

    Yibin, Sichuan

  • Ningxia medical university general hospital

    Yinchuan, Ningxia

  • Yueyang city people's hospital

    Yueyang, Hunan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Placebos, Sulijia
Keywords
Non-small Cell Lung Cancer, Sulijia, Recombinant endostatin, Vinorelbine, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlacebosDrug

    Also called Sodium Chloride Injection

    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)

  • SulijiaDrug

    Also called Recombinant endostatin injection

    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)

Study groups in NCT03117335
Study groupRoleWhat they receive
Vinorelbine plus Cisplatin With placebosActive comparatorThe control group
Receives: Drug: Placebos
Vinorelbine plus Cisplatin With SulijiaExperimentalThe treatment group
Receives: Drug: Sulijia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed up to 24 months

Secondary outcomes (3)

  1. 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).

    Measured: Assessed up to 24 months

  2. 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).

    Measured: Assessed up to 24 months

  3. 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.

    Measured: Assessed up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2017
  2. Study start10 Nov 2011
  3. Primary completion14 Nov 2016
  4. Study completion17 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117335
Sponsor's protocol ID
TG1107RHE
Other IDs
BA2010071
Status last verified
Apr 2017
First submitted
10 Apr 2017
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sulijia in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. at 37 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival(PFS) (time frame: Assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.

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