Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Phase 2
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-jRCTs031180013
- Lead Sponsor
- Kagamu Hiroshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1.Advanced non-small-cell lung cancer
2.History of one regimen or more cytotoxic chemotherapy
3.Twenty years and over
4.Expect survival for more than 3 months
5.ECOG PS 0-1
6.Having measurable leasions
7.Main organs function is maintained
8.With consent of the person or the substitute
Exclusion Criteria
1.Having history of immuno-checkpoint-inhibitor
2.Having history of autoimune disease
3.Having active or symptomatic interstitial lung disease
4.With infections requiring systemic treatment
5.Having symptomatic brain metastasis
6.Having poorly controlled diabetes
7.Having active liver disease
8.Having history of severe hypersensitivity
9.Patient judged inappropriate by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease control rate at 9 weeks from nivolumab treatment
- Secondary Outcome Measures
Name Time Method objective response rate, time to treatment failure, progression-free survival, overall survival, safety, multilateral verification of PBMC biomarker formula, dropout rate