Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer

Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer - Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033411

Enrollment

112

Registered

2018-07-17

Start date

2019-08-01

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 carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent. 2) Age 18 or over. 3) Patients with non-small cell lung cancer diagnosed by histology or cytology. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5) With one or more measurable disease (RECIST ver.1.1). Radiated tumor be excluded. 6) Major organs are held by the examination value within 14 days and clinical examination at the start of treatment meets the following criteria Neut >= 2,500/mm3 Lym>= 500/ul Plt>= 100,000/ul Hb >= 9.0 g/dL CRE <= 1.5 mg/dL T-bil <= x2 facility standard AST/ALT <= x3 facility standard 7) No previus immune-checkpoint inhibitors treatment.

Exclusion criteria

Exclusion criteria: 1) Chemotherapy was used in the past 21 days. Exceptionally administration of tyrosine kinase inhibitors are not to be excluded. 2)Patients with symptomatic brain metastases and meningeal metastases. However, clinically stable brain metastasis cases can be registered. 3) Uncontrolled pleural effusion, pericardial effusion, and/or ascites. 4) Uncontrolled hyperkalemia. 5) Active double cancer within 5years of the first day of nivolumab treatment. 6) Pregnant or breast-feeding female patients. 7) Autoimmune disease. 8) Evident pulmonary fibrosis, organized pneumonia, drug-induced pneumonia or interstitial lung disease. Patients with active pneumonia at screening CT. 9) Serum albumin < 2.5g/dl 10) Patients with active infectious disease (HBV hepatitis, tuberculosis, pneumonia, sepsis etc.) 11) Ptients with serious heart disease. 12) Attenuated live vaccine within 4 weeks of the first dose of nivolumab, or suppose to be needed during the treatment. 13) Immunostimulant (INF, IL-2, etc) within 6 weeks. 14) Immunosuppressant (predonisoron, cyclophosphamide, azathioprine, methotrexate, etc) within 2 weeks.

Design outcomes

Primary

Measure	Time frame
Progression free survival after administration of nivolumab with respect to immune-related gene SNPs.	—

Secondary

Measure	Time frame
Immune-related adverse events after administration of nivolumab with respect to immune-related gene SNPs.	—

Countries

Japan

Contacts

Public ContactTakashi Nomizo

Kyoto University Department of Respiratory Medicine

gnomizo@kuhp.kyoto-u.ac.jp075-751-3830

Outcome results