Endostar First-line Treatment of Advanced NSCLC
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Endostar
Gemcitabine
Cisplatin
Sponsored by

About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring endostar
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 IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
- Must have at least one evaluated lesion,according to the RECIST 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(Eastern Cooperative Oncology Group) PS (performance status ) 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); aspartate aminotransferase(AST) and Alanine aminotransferase(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) basically 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 start, and the patient has recovered;
- Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless 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, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endostar + Gemcitabine and Cisplatin
Gemcitabine and Cisplatin
Arm Description
Patients in this group will be given endostar combined with gemcitabine and cisplatine.
Patients in this group will be given gemcitabine and cisplatine.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
PFS 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, unknown death , or other anti tumor therapy was used.
Secondary Outcome Measures
ORR
overall remission rate
Full Information
NCT ID
NCT03123445
First Posted
April 5, 2017
Last Updated
April 18, 2017
Sponsor
China Medical University, China
Collaborators
The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT03123445
Brief Title
Endostar First-line Treatment of Advanced NSCLC
Official Title
The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
Collaborators
The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
Detailed Description
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
main objectives: PFS (progression-free survival) the secondary goal: ORR (overall response rate), DCR (disease control rate) and OS(overall survival)
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
endostar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar + Gemcitabine and Cisplatin
Arm Type
Experimental
Arm Description
Patients in this group will be given endostar combined with gemcitabine and cisplatine.
Arm Title
Gemcitabine and Cisplatin
Arm Type
Active Comparator
Arm Description
Patients in this group will be given gemcitabine and cisplatine.
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
Recombinant Human Endostatin Injection
Intervention Description
Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS 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, unknown death , or other anti tumor therapy was used.
Time Frame
Time Frame: up to month 36
Secondary Outcome Measure Information:
Title
ORR
Description
overall remission rate
Time Frame
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 IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer.
Must have at least one evaluated lesion,according to the RECIST 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(Eastern Cooperative Oncology Group) PS (performance status ) 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); aspartate aminotransferase(AST) and Alanine aminotransferase(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) basically 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 start, and the patient has recovered;
Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless 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, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(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
liu yunpeng, PhD
Phone
00862483282312
Email
cmu_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
jin bo, PhD
Phone
00862483282542
Email
jb_cmu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liu yunpeng, PhD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25818734
Citation
Wang J, Gu LJ, Fu CX, Cao Z, Chen QY. Endostar combined with chemotherapy compared with chemotherapy alone in the treatment of nonsmall lung carcinoma: A meta-analysis based on Chinese patients. Indian J Cancer. 2014 Mar;51 Suppl 3:e106-9. doi: 10.4103/0019-509X.154099.
Results Reference
background
PubMed Identifier
27428214
Citation
Hu W, Fang J, Nie J, Dai L, Zhang J, Chen X, Ma X, Tian G, Wu D, Han S, Han J, Wang Y, Long J. Efficacy and safety of extended use of platinum-based doublet chemotherapy plus endostatin in patients with advanced nonsmall cell lung cancer. Medicine (Baltimore). 2016 Jul;95(28):e4183. doi: 10.1097/MD.0000000000004183.
Results Reference
background
PubMed Identifier
22917490
Citation
Rong B, Yang S, Li W, Zhang W, Ming Z. Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer. World J Surg Oncol. 2012 Aug 24;10:170. doi: 10.1186/1477-7819-10-170.
Results Reference
background
PubMed Identifier
26434908
Citation
Zhang FL, Gao EY, Shu RB, Wang H, Zhang Y, Sun P, Li M, Tang W, Jiang BQ, Chen SQ, Cui FB. Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging. Asian Pac J Cancer Prev. 2015;16(15):6765-8. doi: 10.7314/apjcp.2015.16.15.6765.
Results Reference
result
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Endostar First-line Treatment of Advanced NSCLC
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