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)
Not Applicable
- Conditions
- advanced or recurrent lung cancer
- Registration Number
- JPRN-UMIN000048096
- Lead Sponsor
- Specified Nonprofit Corporation North East Japan Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 850
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Grade 3 or higher immune-related adverse events
- Secondary Outcome Measures
Name Time Method 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