NCT03958097

Natural Killer(NK) Cell Combined With Programmed Death-1(PD-1) Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer

A Pilot Study of NK Cell Combined With PD-1 Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NK cell and PD-1 antibody	Each patient enrolled the study will received both NK cell and PD-1 antibody.

Timeline

• Start date: 2019-05-17
• Primary completion: 2020-10-21
• Completion: 2021-10-21
• First posted: 2019-05-21
• Last updated: 2024-04-02

Locations

1 site across 1 country: China