A multicenter retrospective observational study evaluating the safety and efficacy of immune checkpoint inhibitors in patients with advanced or recurrent lung cancer after COVID-19 vaccination (NEJ061)

A multicenter retrospective observational study evaluating the safety and efficacy of immune checkpoint inhibitors in patients with advanced or recurrent lung cancer after COVID-19 vaccination (NEJ061) - NEJ061 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048096

Enrollment

850

Registered

2022-06-18

Start date

2022-06-06

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

advanced or recurrent lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically or cytologically confirmed lung cancer 2. incapable of definitive radiation therapy Stage IIIB / IIIC / IV or postoperative recurrence 3. receiving treatments started between January and October 2021 with immune checkpoint inhibitors such as: In case of non-small cell lung cancer - Nivolumab, pembrolizumab, or atezolizumab alone - Nivolumab + ipilimumab (+ platinum combination therapy) - Pembrolizumab + platinum combination therapy - Atezolizumab + platinum combination therapy In case of high-grade neuroendocrine cancer - Atezolizumab (+ platinum combination therapy) - Durvalumab (+ platinum combination therapy) 4. ECOG PS 0-2

Exclusion criteria

Exclusion criteria: 1. active concomitant malignancy 2. interstitial pneumonia or pulmonary fibrosis detectable on CT scan 3. re-administration of immune checkpoint inhibitors (previously PD or toxic discontinuation) 4. with active hepatitis B or hepatitis C 5. with autoimmune disease or a history of autoimmune disease requiring steroid therapy 6. other than autoimmune diseases, continuous systemic or intravenous administration of steroids at doses higher than 10 mg / day in terms of prednisolone is required, and immunosuppressants are used 7. with a history of human immunodeficiency virus

Design outcomes

Primary

Measure	Time frame
Incidence of Grade 3 or higher immune-related adverse events	—

Secondary

Measure	Time frame
Progression-free survival 6 months after ICI administration Incidence of immune-related adverse events in all grades Objective response rate Exacerbation rate of existing immune-related adverse events Side effects of the vaccination Efficacy of the vaccination	—

Countries

Japan

Contacts

Public ContactHideaki Shiraishi

Mitsui Memorial Hospital Respiratory medicine

shiraishi-hideaki@mitsuihosp.or.jp03-3862-9111

Outcome results