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A multi-institutional retrospective study of the efficacy and safety of immune checkpoint blockade for patients with non-small cell lung cancer and pre-existing autoimmune disease (NEJ047)

A multi-institutional retrospective study of the efficacy and safety of immune checkpoint blockade for patients with non-small cell lung cancer and pre-existing autoimmune disease (NEJ047) - NEJ047

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040512
Enrollment
100
Registered
2020-05-25
Start date
2020-04-01
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

Patients with non-small cell lung cancer and pre-existing autoimmune disease

Interventions

None listed

Sponsors

North East Japan Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Advanced/Relapsed non-small cell lung cancer 2. Patients with pre-existing autoimmune disease 3. Either patients who received immune checkpoint inhibitors or not can be included.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
1. Ratio of acute exacerbation of AID in patients with NSCLC and AID who received ICB 2. Rate of serious immune related adverse events (irAE) in patients with NSCLC and AID who received ICB

Secondary

MeasureTime frame
1. Objective response rate (ORR) 2. Progression-free survival (PFS) 3. Overall survival (OS) 4. Time to treatment failure (TTF)

Countries

Japan

Contacts

Public ContactTetsuhiko Asao

Juntendo University Graduate School of Medicine Department of Respiratory Medicine

tasao@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026