An observational study on the probability of pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer

An observational study on the probability of pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer - Pneumonitis in immune-checkpoint inhibitors plus chemotherapy for extensive-stage small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044552

Enrollment

Registered

2021-07-15

Start date

2021-07-15

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

Extensive-stage small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients whose medical information can be obtained from the medical record 2.Patients with extensive-stage or recurrent small cell lung cancer after surgery or chemoradiotherapy 3.Patients who have received at least one course of immune checkpoint inhibitors plus chemotherapy

Exclusion criteria

Exclusion criteria: Patients who have requested not to participate in this study based on published information

Design outcomes

Primary

Measure	Time frame
The incidence of drug-induced lung injury	—

Secondary

Measure	Time frame
Efficacy endpoints 1.Response rate 2.Rate of disease control 3.Progression-free survival 4.Overall survival Safety endpoints 1.Severity of pneumonitis 2.Time to onset of pneumonitis 3.Incidence of lung injury with and without interstitial abnormality 4.Incidence and severity of immune-related adverse events other than pneumonitis 5.Incidence of serious adverse events	—

Countries

Japan

Contacts

Public ContactNaoko Katsurada

Kobe University Graduate School of Medicine Division of Respiratory Medicine, Department of Internal Medicine

nk1208@med.kobe-u.ac.jp0783825660

Outcome results