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

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ClinicalTrials.gov Identifier: NCT02513355
Recruitment Status : Unknown
Verified February 2015 by Nanjing NingQi Medicine Science and Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 31, 2015
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Nanjing NingQi Medicine Science and Technology Co., Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Endostar Drug: Changchun marina Drug: cisplatin Drug: Taxol Drug: parapl Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2015
Estimated Primary Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513355


Contacts
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Contact: Yin Qingfeng, manager 0086-025-85632992 y_qingfeng@163.com

Locations
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China, Jiangsu
Jiangsu Taizhou People's Hospital Recruiting
Nanjing City, Jiangsu, China, 225499
Contact: Qingfeng Yin, Clinical Manager    0086013912903257    y_qingfeng@163.com   
Contact: Xiaolei Zhou, Manager    0086013776639377    zhouxiaolei@simcere.com   
Sponsors and Collaborators
Nanjing NingQi Medicine Science and Technology Co., Ltd.
Investigators
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Study Chair: Han gaohua, PI China:Taizhou people's hospital

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Responsible Party: Nanjing NingQi Medicine Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02513355     History of Changes
Other Study ID Numbers: JS-ENDO-001
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: February 2015
Keywords provided by Nanjing NingQi Medicine Science and Technology Co., Ltd.:
Non-small cell lung cancer,Endostar
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Paclitaxel
Endostar protein
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors