Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.

Detailed Description
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All eligible patients will receive SB injection therapy for 4 cycles (14 21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles.

Official Title
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Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: SB injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-70 years Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy. Patients with measurable lesions Eatern Cooperative Oncolgy Group status 0 to 2. Life expectancy >/= 5 months Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L Total bilirubin </= upper limit of normal Aspartate Aminotransferase and/or Alanine Aminotransferase </= 2 x upeer limit of normal creatinine </= 1.5 x upeer limit of normal Patients who have signed the informed consent form. Exclusion Criteria: Female volunteers admitted to the study must be using a reliable means of contraception Received radiation therapy within 6 weeks before randomization Known brain or spinal cord metastases Have acute infection Have active infection or serious concomitant systemic disorder incompatible with the study Presence or history of malignancy other than Non-Small Cell Lung Cancer Have severe neurologic or psychological disorder Patients who have to receive other chemo-radiotherapy or immunotherapy Patients who have received chemotherapy within the previous 30 days Patients who are candidates for combined modality treatment. Patients who have participated in a clinical study within the previous 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB injection|Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Best Response Rate |  | 2.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine duration of response rate by measuring time to progression |  | 2.5 months | 
| Pain Scores on the Visual Analog Scale |  | 2.5months | 
| Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale |  | 2.5months |