Non Small Cell Lung Cancer Clinical Trial
Official title:
A Cohort Study to Evaluate the Impact of Inactivated Trivalent Influenza Vaccine on the Immunogenicity, Safety and Survival of Non-small Cell Lung Cancer Patients Receiving PD-1 / PD-L1 Inhibitors
This project is to assess the immunogenicity, safety and overall survival impact of intramuscular injection of trivalent influenza vaccine in non-small cell lung cancer (NSCLC) patients with PD-1/PD-L1 inhibitor treatment.
Lung cancer is one of the most prevalent cancers in the world. Among them, non-small cell
lung cancer (NSCLC) accounts for about 85%. Immune checkpoint inhibitors such as programmed
death 1(PD-1) and PD-L1 are new treatments for NSCLC. About 290,000 to 650,000 people die
from respiratory illnesses caused by seasonal flu all over the world. Cancer patients are one
of the high-risk groups of influenza. Although the United States, Britain, Australia have
issued guidelines recommending that cancer patients be vaccinated against influenza every
year, due to concerns about the immune effect and safety of flu vaccination for cancer
patients, multiple countries including China have not included cancer patients into priority
influenza vaccination populations. Therefore, how to further prove the immunogenicity and
safety of influenza vaccine in NSCLC patients is the key to promote influenza vaccines in
NSCLC patients.
This study will recruit 130 patients with NSCLC who have been treated with PD-1 / PD-L1
inhibitors for 6 months or more and 30 healthy participants. Among them, 100 NSCLC patients
and 30 healthy participants will be intramuscularly inactivated with a trivalent influenza
vaccine during the influenza seasons 2020-21 and 2021-22. Vaccinated participants' peripheral
blood samples were collected at day0, 12 hours, day1, 2, 7, 21, 30, 60 and 6 months after
vaccination. The influenza specific antibody titers, inflammatory chemokines and cytokines,
antibody-dependent cellular cytotoxicity (ADCC) activity, T lymphocytes activity and the
proportions of different T cells subgroups will be measured to evaluate the participants'
immune response to the vaccine. In addition, for the subjects receiving the vaccine, the
study will also group by age to compare the differences in immune effects between subjects
aged 18-65 and subjects over 65.
At last, this project will compare immune-related adverse events (irAEs) that occurred after
receiving PD-1 / PD-L1 inhibitor therapy and survival time between NSCLC patients who receive
influenza vaccine and those who do not receive influenza vaccine.
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