Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker

Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker - Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028468

Enrollment

Registered

2017-08-01

Start date

2017-08-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small-cell lung cancer

Interventions

nivolumab monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
disease control rate at 9 weeks from nivolumab treatment	—

Secondary

Measure	Time frame
objective response rate,time to treatment failure, progression-free survival, overall survival, dropout rate	—

Countries

Japan

Contacts

Public ContactOu Yamaguchi

Saitame Medical University International Medical Center division of respiratory medicine

ouyamagu@saitama-med.ac.jp042-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026