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
- 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
1. Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L
2. Total bilirubin = upper limit of normal
3. Aspartate Aminotransferase and/or Alanine Aminotransferase = 2 x upeer limit
4. creatinine = 1.5 x upeer limit of normal
- Patients who have signed the informed consent form.
- Female volunteers admitted to the study must be using a reliable means of
- 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
- 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