Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer

Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer - Biomarker studies for nivolumab

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026040

Enrollment

Registered

2017-02-07

Start date

2017-02-22

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

unresectable or recurrent non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Leucocyte>3,000/mm3 and <12,000/mm3 Hemoglobin>9.0 g/dL Platelet>100,000/mm3 AST<100 IU/L ALT<100 IU/L T.Bil<2.0 mg/dL Serum creatinine<1.5 mg/dL

Exclusion criteria

Exclusion criteria: (1)Subjects with autoimmune disease. (2)Subjects with interstitial lung disease. (3)Receiving continuous systemic corticosteroid. (4)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. (5)Patients with a history of hypersensitivity to nivolumab. (6)Dementia or psychological disorder difficult to participate in this clinical study.

Design outcomes

Primary

Measure	Time frame
To evaluate the biomarkers for efficacy of nivolumab using blood samples.	—

Secondary

Measure	Time frame
response rate, overall survival, progression-free survival, rate of side effects	—

Countries

Japan

Contacts

Public ContactToshiyuki Nagata

Kagoshima University Graduate School of Medical and Dental Sciences Department of General Thoracic Surgery

nagatosh@m2.kufm.kagoshima-u.ac.jp099-275-6490

Outcome results