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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513342
Recruitment Status : Unknown
Verified March 2015 by Nanjing NingQi Medicine Science and Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Nanjing NingQi Medicine Science and Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced Lung Squamous Carcinoma Biological: Endostar Drug: Docetaxel Drug: Cisplatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endostar+Docetaxel+Cisplatin
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.
Biological: Endostar
Endostar 30mg continuous intravenous injection pump,d1-d7;

Drug: Docetaxel
d4 Docetaxel,75(mg/m2),iv;

Drug: Cisplatin
d4,cisplatin,75(mg/m2),iv;

Active Comparator: Docetaxel+Cisplatin
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.
Drug: Docetaxel
d4 Docetaxel,75(mg/m2),iv;

Drug: Cisplatin
d4,cisplatin,75(mg/m2),iv;




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to month 36 ]
    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 :
  1. 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. ]
  2. 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. ]
  3. 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. ]


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:

  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.

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): NCT02513342


Contacts
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Contact: Yin Qingfeng, manager 0086-02585632992 y_qingfeng@163.com
Contact: Zhou Xiaolei, sponsor 0086-02585566666 zhouxiaolei@simcere.com

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Yin Qingfeng, Manager    0086013912903257    y_qingfeng@163.com   
Contact: Zhou Xiaolei, Manager    0086013776639377    zhouxiaolei@simcere.com   
Principal Investigator: Song Yong, director         
The first affiliated hospital of soochow university Recruiting
Soochow, Jiangsu, China, 215006
Contact: Yin Qingfeng, mananger    08613912903257    y_qingfeng@163.com   
Contact: Zhou Xiaolei, mananger    08613776639377    zhouxiaolei@simcere.com   
Principal Investigator: Huang Jianan, director         
Sponsors and Collaborators
Nanjing NingQi Medicine Science and Technology Co., Ltd.

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Responsible Party: Nanjing NingQi Medicine Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02513342     History of Changes
Other Study ID Numbers: JSLCG-001
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: March 2015
Keywords provided by Nanjing NingQi Medicine Science and Technology Co., Ltd.:
Endostar,Advanced lung squamous carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cisplatin
Docetaxel
Endostar protein
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors