A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.

A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor. - Association between immune related adverse events and novel coronavirus vaccine for advanced lung cancer patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044213

Enrollment

100

Registered

2021-05-14

Start date

2021-05-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have NSCLC with histologically or cytologically confirmed Patients who have locally advanced, metastatic or recurrent lung cancer Patients who are treated/will be treated with immune checkpoint inhibitor Patients who have willing to receive the SARS-Cov-2 vaccine, but have not yet been vaccinated Patients are enrolled if they are over 20 years old Patients are enrolled if they can write written consent form after they listen the explanation of this study and consent the study.

Exclusion criteria

Exclusion criteria: Patients that doctor in charge consider them inappropriate as a subject Patients who had already infected with COVID-19

Design outcomes

Primary

Measure	Time frame
The frequency of adverse events related with immune checkpoint inhibitor in 3 months after the vaccination.	—

Secondary

Measure	Time frame
The frequency of adverse events related with immune checkpoint inhibitor in 6 months after the vaccination. The frequency of adverse reactions after the vaccination The rate of vaccination during the observation period of this study. The rate of infection for COVID-19 after the vaccination	—

Countries

Japan

Contacts

Public ContactShoko Kawai

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Department of Respiratory Medicine

river.happiness@cick.jp03-3823-2101

Outcome results