Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan

Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan - Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination in lung cancer patients receiving immune checkpoint inhibitors: A multicenter observational study in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044316

Enrollment

Registered

2021-05-25

Start date

2021-05-25

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 were at least 20 years of age were eligible for enrollment if they had pathologically or cytologically confirmed lung cancer of any histological type; had locally advanced and unresectable, metastatic, and/or recurrent disease; and had been treated with immune checkpoint inhibitors anti-PD1/anti-PDL1 antibodies: Nivolumab, Pembrolizumab, Durvarmab, and Atezolizumab) as monotherapy or in combination with other drugs at least once between 4 weeks prior to the first dose of the SARS-CoV-2 vaccine and 4 weeks after the second dose of the vaccine.

Exclusion criteria

Exclusion criteria: Patients were excluded if they were in the following condition; (1) having already received the vaccine; (2) not wishing to be vaccinated by their own choice or on the recommendation of their physician; and (3) did not provide informed consent.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of all irAEs of all grades.	—

Countries

Japan

Contacts

Public ContactMakoto Hibino

Shonan Fujisawa Tokushukai Hospital Department of Respiratory Medicine

m-hibino@ctmc.jp0466-35-1177

Outcome results