PD-1 antibody has been approved as second line therapy for driven mutation negative non-small cell lung cancer, but overall response rate is only between 15-20%. Basic study found NK cell can enhance anti-tumor ability of PD-L1 antibody. This study evaluates the efficacy and safety of NK cell combined with PD-1 antibody for advanced driven mutation negative non-small cell lung cancer (NSCLC) as second-line therapy.
The incidence of non-small cell lung cancer is high, and most patients are in advanced stage at the time of diagnosis, and the overall prognosis is poor. Currently, patients with advanced non-small cell lung cancer are treated individually according to the molecular and histological features of the tumor. For patients with negative driver mutation in epidermal growth factor receptor(EGFR), anaplastic lymphoma kinase(ALK),ROS proto-oncogene1(ROS1), v-raf murine sarcoma viral oncogene homolog B1(BRAF) and other driving genes, platinum-based dual chemotherapy combined with PD-1/PD-L1 monoclonal antibody is recommended for first-line treatment. In patients who have not used PD-1/PD-L1 antibody in first-line therapy, the second-line treatment regimen is the first choice for the recommended single-agent PD-1/PD-L1 antibody. However, the current efficacy of PD-1/PD-L1 antibody for second-line treatment of advanced non-small cell lung cancer is limited, only between 15-20%. NK cells secrete interferon(IFN) to promote the expression of PD-L1 in tumor cells and enhance the role of PD-1 inhibitors. At the same time, PD-1 antibodies can bind to NK cell surface PD-1, prevent NK cell depletion, and enhance NK cell anti-tumor. Therefore, the application of NK cells combined with PD-1 antibody in the treatment of patients with advanced non-small cell lung cancer may achieve better results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Each patient enrolled the study will received both NK cell and PD-1 antibody.
First Hospital of Jilin University
Changchun, Jilin, China
Progression Free Survival(PFS)
From the random date until the date when the objective disease progression (evaluated by the investigator according to RECIST 1.1) or for any reason (whichever occurs first) is confirmed, based on the intent to treat(ITT) set.
Time frame: 12 months
Overall Response Rate(ORR)
The proportion of patients with complete response(CR) or partial response(PR) (evaluated by the investigator according to RECIST 1.1), based on the ITT set.
Time frame: 12 months
Overall Survival(OS)
The time from the random date to the date of death for any reason, based on the ITT population.
Time frame: 12 months
Duration of Response(DoR)
The time from the first confirmed objective remission to recurrence (evaluated by the investigator according to RECIST 1.1) or for any reason, whichever occurs first.
Time frame: 12 months
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