Stage IV NSCLC
Conditions
Brief summary
This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.
Interventions
30gm IV infusion 5 days a week for 3 weeks every 28 days
Sponsors
KangLaiTe USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* confirmed (within last 3 months)progressive Stage IV NSCLC * estimated life span of 3 months * phase angle of at least 5 as measured by bioimpedance
Exclusion criteria
* currently taking a lipid lowering medications * has an imminently life threatening condition * has pre-existing liver disease * known allergy to soybeans * uncontrolled diabetes or uncontrolled disturbance of lipid metabolism * pregnant or lactating * has a pacemaker or other implantable electronic medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | from date of enrollment until date of death from any cause assessed up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioimpedance Phase Angle | measured each month up to one year | — |
| Palliation Response Measure | each month up to one year | quality of life survey and performance status |
Countries
United States
Outcome results
None listed