Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Recombinant human endostatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostar Arm<br>Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14 | Drug: Recombinant human endostatin<br>* Recombinant human endostatin 7.5mg/m2<br>* Other names: Endostar;|
| Active Comparator: Standard Arm<br>Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Responese Rate |  | in two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR-TKI, endostar, angiogenesis, lung caner