NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiednon-small-cell lung cancer
Date of first enrollment04/08/2017
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)nivolumab monotherapy

Outcome(s)

Primary Outcomedisease control rate at 9 weeks from nivolumab treatment
Secondary Outcomeobjective 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
Age maximumNot applicable
GenderBoth
Include criteria1.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 criteria1.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

Contact

Public contact
Name Ou Yamaguchi
Address 1397-1, Yamane, Hidaka-city, Saitama Saitama Japan 350-1298
Telephone +81-42-984-4111
E-mail 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
E-mail kagamu19@saitama-med.ac.jp
Affiliation Saitama Medical University International Medical Center