A study to evaluate the relation between the efficacy and early Immune Related Advers Events of Nivolmab in patients with non-small cell lung cancer
Not Applicable
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000021560
- Lead Sponsor
- Kobe city medical center general hospital
- Brief Summary
Patients with irAEs were associated with a significantly longer median progression-free survival than those without. These findings were comparable to those for patients with and without irAEs 6 weeks after commencement of nivolumab treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
Not provided
Exclusion Criteria
1)Subjects with autoimmune disease. 2)Subjects with interstitial lung disease. 3)Receiving continuous systemic corticosteroid. 4)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 5)Dementia or psychological disorder difficult to participate in this clinical study. 6)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes, Intestinal obstruction.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate,progression free survival
- Secondary Outcome Measures
Name Time Method disease control rate overall survival