JRCT ID: jRCTs031180013
Registered date:07/08/2018
Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | non-small-cell lung cancer |
Date of first enrollment | 04/08/2017 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | nivolumab monotherapy |
Outcome(s)
Primary Outcome | disease control rate at 9 weeks from nivolumab treatment |
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Secondary Outcome | objective response rate, time to treatment failure, progression-free survival, overall survival, safety, multilateral verification of PBMC biomarker formula, dropout rate |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Kagamu Hiroshi |
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Secondary Sponsor | Nonprofit Organization, North East Japan Study Group |
Source(s) of Monetary Support | Bristol-Myers Squibb K.K. |
Secondary ID(s) | UMIN000028468 |
Contact
Public contact | |
Name | Ou Yamaguchi |
Address | 1397-1, Yamane, Hidaka-city, Saitama Saitama Japan 350-1298 |
Telephone | +81-42-984-4111 |
ouyamagu@saitama-med.ac.jp | |
Affiliation | Saitama Medical University International Medical Center |
Scientific contact | |
Name | Hiroshi Kagamu |
Address | 1397-1, Yamane, Hidaka-city, Saitama Saitama Japan 350-1298 |
Telephone | +81-42-984-4111 |
kagamu19@saitama-med.ac.jp | |
Affiliation | Saitama Medical University International Medical Center |