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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Endostar
Changchun marina
cisplatin
Taxol
parapl
Sponsored by
Nanjing NingQi Medicine Science and Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer,Endostar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu Taizhou People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NP(Changchun marina+cisplatin)+Endostar

TP(Taxol+cisplatin or parapl) +Endostar

Arm Description

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

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.

Outcomes

Primary Outcome Measures

PFS(progression-free survival)
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

ORR(Objective Response Rate)
DCR(disease control rate)
OS(overall survival)

Full Information

First Posted
July 17, 2015
Last Updated
July 31, 2015
Sponsor
Nanjing NingQi Medicine Science and Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02513355
Brief Title
Endostar Treatment of Advanced Non-small Cell Lung Cancer Multi-center Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing NingQi Medicine Science and Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer,Endostar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NP(Changchun marina+cisplatin)+Endostar
Arm Type
Experimental
Arm Description
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
Arm Title
TP(Taxol+cisplatin or parapl) +Endostar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Endostar
Intervention Description
Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Changchun marina
Intervention Description
25mg/m2,d1 and d8,q21d×4
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
80mg/m2,d1, q21d×4
Intervention Type
Drug
Intervention Name(s)
Taxol
Intervention Description
135-175mg/m2,d1,q21d×4
Intervention Type
Drug
Intervention Name(s)
parapl
Intervention Description
AUC=5-6,d1,q21d×4
Primary Outcome Measure Information:
Title
PFS(progression-free survival)
Description
PFS is refers to the patients randomly into group to the date of any objective records of patients with tumor progression or death time.
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin Qingfeng, manager
Phone
0086-025-85632992
Email
y_qingfeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han gaohua, PI
Organizational Affiliation
China:Taizhou people's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangsu Taizhou People's Hospital
City
Nanjing City
State/Province
Jiangsu
ZIP/Postal Code
225499
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingfeng Yin, Clinical Manager
Phone
0086013912903257
Email
y_qingfeng@163.com
First Name & Middle Initial & Last Name & Degree
Xiaolei Zhou, Manager
Phone
0086013776639377
Email
zhouxiaolei@simcere.com

12. IPD Sharing Statement

Learn more about this trial

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

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