Endostar Treatment of Advanced Non-small Cell Lung Cancer Multi-center Clinical Research

July 31, 2015 updated by: Nanjing NingQi Medicine Science and Technology Co., Ltd.

Research purpose:

Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

1.Research purpose: Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination chemotherapy regimens including cisplatin two medicine first-line treatment of advanced non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.

2.1 main objectives: PFS 2.2 the secondary goal: 2.2. 1 ORR, DCR and OS 2.2. 2 the quality of life 3. The study design 3.1 research nature This is a single arm, multicenter clinical study, is expected to total 100 patients into the group.

Hierarchical factors include: the tumor staging (Ⅲ B vs Ⅳ), ECOG score (0 v 1), gender (male vs female).

3.2 research center and research Proposed by taizhou people's hospital and medical association of jiangsu province tumor chemotherapy and biological branch of the lung cancer group led by several large and medium-sized hospitals in the province of the malignant tumor treatment related department to participate, in accordance with the unified test plan of this research.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing City, Jiangsu, China, 225499
        • Recruiting
        • Jiangsu Taizhou People's Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic confirmation cytology or not in patients undergoing single sputum cytology in the diagnosis of patients with non-small cell lung cancer;
  • according to a new IASLC2009 lung cancer TNM stages judged the preious untreated stage IIIB or IV non-small cell lung cancer (with the exception of EGFR/ALK mutations type);
  • must have at least one according to the RRECIST version 1.1 standard judgment to evaluate lesions (at least 10 mm, maximum diameter on spiral CT plain CT longest diameter at least 20 mm);
  • male or female, age 18 and 75 years old or less or more;
  • ECOG PS 0 ~ 1 minute;
  • is expected to survive period for 3 months or more,
  • enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;
  • Liver function enough: upper limit of total bilirubin acuities were normal (ULN); AST and ALT acuities were 2.5 times the upper limit of normal (ULN); Alkaline phosphatase 5 times the upper limit of normal or less (ULN);
  • enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min.
  • basic normal ecg, had on the body to heal wounds;
  • always not received anti-tumor drug therapy, or always only for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but to study treatment has ended more than six months at the beginning;
  • ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered;
  • a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months). If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery).
  • prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
  • signed informed consent.

Exclusion criteria

  • pregnancy, nursing mothers, or fertility but not women using contraception;
  • the existing serious acute infection, and not be controlled; Or fester sex and chronic infection, wound in delay no more;
  • the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  • is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit;
  • with bleeding tendency;
  • other researchers believe that patients should not participate in this test.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NP(Changchun marina+cisplatin)+Endostar
Patients in this group will be given conventional chemotherapy medicine,NP plan (Changchun marina+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer. Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles;Changchun marina;25mg/m2,d1 and d8,cisplatin 80mg/m2,d1, q21d×4
Biological: Endostar
Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles
Drug: Changchun marina
25mg/m2,d1 and d8,q21d×4
Drug: cisplatin
80mg/m2,d1, q21d×4
Experimental: TP(Taxol+cisplatin or parapl) +Endostar

Patients in this group will be given conventional chemotherapy medicine,TP(Taxol+cisplatin)recommended by treatment guidelines for Advanced non small cell lung cancer.

Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles; Taxol;135-175mg/m2,d1,cisplatin or parapl 75mg/m2,d1,q21d×4.
Biological: Endostar
Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles
Drug: cisplatin
80mg/m2,d1, q21d×4
Drug: Taxol
135-175mg/m2,d1,q21d×4
Drug: parapl
AUC=5-6,d1,q21d×4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS（progression-free survival）
Time Frame: Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
PFS is refers to the patients randomly into group to the date of any objective records of patients with tumor progression or death time.
Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Secondary Outcome Measures

Outcome Measure
Time Frame
ORR（Objective Response Rate）
Time Frame: 1 weeks before treatment, Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
1 weeks before treatment, Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
DCR(disease control rate)
Time Frame: Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
OS（overall survival）
Time Frame: Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Collaborators and Investigators

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

Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Investigators

  • Study Chair: Han gaohua, PI, China:Taizhou people's hospital

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

February 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-ENDO-001

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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