Advanced Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Sulijia, Recombinant endostatin, Vinorelbine, Cisplatin
Brief summary
The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia) combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) , disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.
Detailed description
Recombinant endostatin injection Sulijia is a new type of recombinant protein drugs inhibiting tumor angiogenesis developed by a group of Chinese scientists and clinician. It is expressed in E. coli which Consists of 184 amino acids. It appears to be better than NP chemotherapy alone in terms of efficacy in phase I/II trials for advanced NSCLC. In this study, a randomized, double-blind, Placebo plus NP as control, multi-center phase III trial was designed to evaluate the safety and efficacy of Sulijia plus NP in the treatment of advanced NSCLC patients. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), DCR (disease control rate) and safety as the secondary end-point. A total of 560 patients have been recruited.
Interventions
DRUGPlacebos
Drug 1: Placebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress） Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)
DRUGSulijia
Drug 1: Sulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress） Drug 2: Vinorelbine-Cisplatin: Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)
Sponsors
Tigermed Consulting Co., Ltd
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female aged 18 to 70 years old; 2. Patients with histological confirmed stage IV NSCLC; 3. According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter \>=10mm by spiral CT, PET-CT, with the largest diameter \>=20mm by ordinary CT and MRI; 4. general condition ECOG performance scale (PS) 0-1; 5. Life expectancy of more than 3 months; 6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \> 1.5\*10\^9/L, platelet count\> 90\*10\^9/L, hemoglobin\> 9g/dL; liver function: serum bilirubin was less than 2\* maximum normal value; ALT and AST were less than 2.5\*maximum normal value; BUN, Cr within 80% of normal range; 7. Patients could understand the circumstances of this study and those who have signed the informed consent form.
Exclusion criteria
1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time; 2. Patients who have uncontrolled brain metastasis; 3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer; 4. Pregnant or lactating women; 5. Severe infected patients; 6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure; 7. Patients who have vein thrombus; 8. Patients who have psychiatric illness; 9. Patients who are allergic to E. coli preparation; 10. Researchers believe that those who do not fit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | Assessed up to 24 months | A duration from date of randomization until the date of first documented progression (as defined by RECIST 1.1) or date of death from any cause, whichever came first. A participant will be censored at the last date they are known not to be progressed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | Assessed up to 24 months | Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR) (as defined by RECIST 1.1). |
| Disease control rate(DCR) | Assessed up to 24 months | Disease Control Rate is defined as the proportion of patients with complete response(CR), partial response(PR), or stable disease(SD) (as defined by RECIST 1.1). |
| Overall survival(OS) | Assessed up to 72 months | Overall Survival is assessed via calculation of the time to death due to any cause. A participant will be censored at the last date they are known to be alive. |
Countries
China
Outcome results
None listed