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Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma

Primary Purpose

Advanced Lung Squamous Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Endostar
Docetaxel
Cisplatin
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 Advanced Lung Squamous Carcinoma focused on measuring Endostar,Advanced lung squamous carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Cytological and histological confirmation(Do not accept single sputum cytology in the diagnosis of patients) in patients diagnosed of lung squamous carcinoma;
  2. According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer.
  3. Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm);
  4. Male or female, age between 18 and 75 years old ;
  5. ECOG PS 0~1;
  6. Expected survival period ≥ 3 months or more
  7. Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL;
  8. Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN);
  9. Enough renal function:serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min.
  10. The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds
  11. No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start.
  12. Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered;
  13. Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery).
  14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
  15. Sign the informed consent.

Exclusion Criteria:

  1. Pregnancy, nursing mothers, or female patients with fertility but no contraception.
  2. Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay;
  3. Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  4. With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit;
  5. With a bleeding tendency
  6. Researchers believe that patients should not participate in this test.

Sites / Locations

  • Jinling HospitalRecruiting
  • The first affiliated hospital of soochow universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endostar+Docetaxel+Cisplatin

Docetaxel+Cisplatin

Arm Description

Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7.

Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
FS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknow death , or other anti tumor therapy was used.

Secondary Outcome Measures

overall remission rate(ORR)
Disease control rate (DCR)
Overall survival(OS)

Full Information

First Posted
July 17, 2015
Last Updated
July 30, 2015
Sponsor
Nanjing NingQi Medicine Science and Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02513342
Brief Title
Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma
Official Title
Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma Based on Chemotherapy for Advanced Non-small Cell Lung Squamous Carcinoma Patients:a Randomized Controlled,Open, Multicenter Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

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
No

5. Study Description

Brief Summary
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance treatment., and explore the predicted biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Lung Squamous Carcinoma
Keywords
Endostar,Advanced lung squamous carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endostar+Docetaxel+Cisplatin
Arm Type
Experimental
Arm Description
Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma , and the Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7.
Arm Title
Docetaxel+Cisplatin
Arm Type
Active Comparator
Arm Description
Patients in this group will be given conventional chemotherapy medicine: Docetaxel+Cisplatin chemotherapy recommended by treatment guidelines for Advanced Non-small Cell Lung Squamous Carcinoma.
Intervention Type
Biological
Intervention Name(s)
Endostar
Intervention Description
Endostar 30mg continuous intravenous injection pump,d1-d7;
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
d4 Docetaxel,75(mg/m2),iv;
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
d4,cisplatin,75(mg/m2),iv;
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
FS is a tumor progression or death time of a patient who has an objective record on the date of enrollment. PFS calculation end if the patient was lost, unknow death , or other anti tumor therapy was used.
Time Frame
up to month 36
Secondary Outcome Measure Information:
Title
overall remission rate(ORR)
Time Frame
change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Title
Disease control rate (DCR)
Time Frame
change from Baseline at the week 6, 12 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Title
Overall survival(OS)
Time Frame
change from Baseline at the week 6, 12 of the treatment phase, 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: Cytological and histological confirmation(Do not accept single sputum cytology in the diagnosis of patients) in patients diagnosed of lung squamous carcinoma; According to a new IASLC2009 lung cancer TNM stages judged stage IIIB or IV non-small cell lung cancer. Must have at least one evaluated lesion,according to the RRECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm); Male or female, age between 18 and 75 years old ; ECOG PS 0~1; Expected survival period ≥ 3 months or more Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL; Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); AST and ALT acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN); Enough renal function:serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min. The electrocardiogram (ecg) basicaly normal,the body had no to heal wounds No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start. Patients had surgery before,but have more than 4 weeks before the study star, and the patient has recovered; Women with cmpleted uterus before intact in the group within 28 days must have a negative pregnancy test results (unles amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery). Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions; Sign the informed consent. Exclusion Criteria: Pregnancy, nursing mothers, or female patients with fertility but no contraception. Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay; Original serious heart disease, including: congestive heart failure, uncontroled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension; With uncontroled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontroled primary brain tumors or CNS metastases illness, with obvious symptoms in cranial hypertension or nerve spirit; With a bleeding tendency 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
0086-02585632992
Email
y_qingfeng@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Xiaolei, sponsor
Phone
0086-02585566666
Email
zhouxiaolei@simcere.com
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yin Qingfeng, Manager
Phone
0086013912903257
Email
y_qingfeng@163.com
First Name & Middle Initial & Last Name & Degree
Zhou Xiaolei, Manager
Phone
0086013776639377
Email
zhouxiaolei@simcere.com
First Name & Middle Initial & Last Name & Degree
Song Yong, director
Facility Name
The first affiliated hospital of soochow university
City
Soochow
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yin Qingfeng, mananger
Phone
08613912903257
Email
y_qingfeng@163.com
First Name & Middle Initial & Last Name & Degree
Zhou Xiaolei, mananger
Phone
08613776639377
Email
zhouxiaolei@simcere.com
First Name & Middle Initial & Last Name & Degree
Huang Jianan, director

12. IPD Sharing Statement

Learn more about this trial

Endostar First-line Treatment of Advanced Non-small Cell Lung Squamous Carcinoma

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