Non Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.
Detailed description
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.
Interventions
DRUGSB injection
Infusion SBinjection of 21.87ml/m\^2, Intravenous route, 16times for 2.5 months
Sponsors
SBPharmaceutical IND, Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 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 of normal 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Best Response Rate | 2.5 months |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactChae-young Lee, Medical Doctor
Backup ContactA-young Shin, Registered Nurse
Outcome results
None listed