Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer

Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer - Study of biomarkers predicting response to nivolumab in NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022505

Enrollment

200

Registered

2016-06-30

Start date

2016-06-30

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Receiving nivolumab therapy 2. Histologically proven advanced or recurrent NSCLC 3. Chemotherapy pre-treated 4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 5. Adequate specimens available for FISH and IHC analyses 6. Life expectancy of more than 3 months 7. Aged equal to or greater than 18 years old 8. Written informed concent

Exclusion criteria

Exclusion criteria: 1. Combined autoimmune disease or history of recurrent autoimmune disease 2. Interstitial lung disease 3. Severe medical comorbidities 4. Uncontrolled brain metastases

Design outcomes

Primary

Measure	Time frame
Association of the response rate of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.	—

Secondary

Measure	Time frame
Association of progression-free survival and overall survival of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.	—

Countries

Japan

Contacts

Public ContactYusuke Inoue

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

yusukeinoue0421@yahoo.co.jp053-435-2263

Outcome results