A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia
- Conditions
- on-small cell lung cancer patients with interstitial pneumonia
- Registration Number
- JPRN-UMIN000030699
- Lead Sponsor
- Kitasato University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Not provided
1) Systemic administration of steroids at 10 mg/day or more in terms of predonin 2) Active infection requiring systemic treatment 3) Fever of 38 degrees or more at axillary temperature at registration 4) Mental illness or psychiatric symptoms 5) Symptomatic brain metastases 6) Poor control hypertension 7) Continuous systemic administration of immunosuppressants 8) Poor control diabetes 9) Hypersensitivity to the drug 10) Pregnant women, lactating women, women who may be pregnant, or they are not willing to contraceptive 11) In addition, cases judged inappropriate by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exacerbation rate of interstitial lung diseases up to 6 months after initiation of immune checkpoint inhibitors
- Secondary Outcome Measures
Name Time Method Overall response rate, Progression free survival, Overall survival, Adverse events, Risk factors developing exacerbation of interstial lung disease