Lung Cancer
Conditions
Keywords
endostar, angiogenesis, EGFR-TKI, lung caner
Brief summary
Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.
Detailed description
Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.
Interventions
Recombinant human endostatin 7.5mg/m2
DRUGPlacebo
Placebo
Sponsors
Peking University Third Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy. * Life expectancy of at least three (3) months after the start of administration of the investigational drug. * Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2. * Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and \>=10 mm. * Patient received at least 6 months EGFR-TKI and show tumor progress * Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy * Patient signed consent form and adherence and geographic location are liable to follow up
Exclusion criteria
* CNS metastasis * Active infection * Bleeding tendency or blood coagulation dysfunction * History of neurological or psychiatric disorders, including epilepsy, or dementia * Pregnancy or breast-feeding women * Organ transplant long-term use of immunosuppressive drugs * Arrhythmia need anti-arrhythmic treatment or other risk of heart disease * Use other targeted drugs during the research * Other conditions may not allowed to join in this study according to the researcher's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Responese Rate | in two months |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | up to six months |
| Overall Survial | follow up every two months, about two years |
| Number of Serious Adverse Events | within two months |
Countries
China
Contacts
Primary ContactLi Liang, MD
Outcome results
None listed