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

Phase 2

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT01305967
• Lead Sponsor: SBPharmaceutical IND, Co., LTD

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.

Study Timeline

• Study Start: 2003-01
• Status Verified: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-27
• Last Update Submitted: 2011-02-27
• Study First Posted: 2011-03-01
• Last Update Posted: 2011-03-01
• Primary Completion: 2011-05
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Best Response Rate	2.5 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Jung-gu, Korea, Republic of

Sam Anyang Medical Center; 🇰🇷 Anyang, Man-an-gu, Korea, Republic of

Kyungpook University Hospital; 🇰🇷 Deagu, Jung-gu, Korea, Republic of