Prospective observational study to investigate serum interleukin-6 levels prior to immune checkpoint inhibitor treatment and the occurrence of immune-related adverse events with immune checkpoint inhibitors for non-small cell lung cancer.

Prospective observational study to investigate serum interleukin-6 levels prior to immune checkpoint inhibitor treatment and the occurrence of immune-related adverse events with immune checkpoint inhibitors for non-small cell lung cancer. - IL-6 and immune-related adverse events in patients with non-small cell lung cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054713

Enrollment

Registered

2024-07-01

Start date

2024-07-01

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 cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years and over 2) Patients capable of giving written consent 3) Patients with negative therapeutic target driver gene mutations/translocations 4) Patients who plan to use immune checkpoint inhibitors as first-line therapy

Exclusion criteria

Exclusion criteria: 1) Patients previously treated with immune checkpoint inhibitors 2) Patients with a history of treatment with cytotoxic anticancer drugs within 6 months 3) Patients with positive driver gene mutations/translocations 4) Patients with coexisting autoimmune diseases 5) Patients with active infections 6) Patients with an estimated prognosis of less than 2 months

Design outcomes

Primary

Measure	Time frame
Frequency of immune-related adverse events.	—

Secondary

Measure	Time frame
Efficacy (1-year PFS, ORR) and prognosis (1-year OS) of immune checkpoint inhibitors	—

Countries

Japan

Contacts

Public ContactTomoki Tamura

NHO Iwakuni Clinical Center Respiratory Medicine

tomoki19830211@gmail.com0827-34-1000

Outcome results