Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment

Summary

The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. ANKL (2x10\*9) from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR, increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)

Timeline

Start

2015-02

Primary completion

2018-08

Completion

2020-02

Drugs

Indications