Study for examining residual durvalumab effect on immune system after durvalumab consolidation therapy in unresectable locally advanced non-small cell lung cancer.

Study for examining residual durvalumab effect on immune system after durvalumab consolidation therapy in unresectable locally advanced non-small cell lung cancer. - PKPD study of durvalumab

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051069

Enrollment

Registered

2023-05-16

Start date

2019-08-06

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 treated with durvalumab

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically or cytologically diagnosed NSCLC 2) Patients who are expected to complete durvalumab therapy following radical chemoradiotherapy for unresectable locally advanced NSCLC. 3) Patients who have given their written consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Patients who cannot give consent for specimen collection 2) Other patients who are judged by the principal investigator or the physician in charge to be inappropriate as subjects for this study.

Design outcomes

Primary

Measure	Time frame
Changes in blood levels and immune status after completion of durvalumab treatment	—

Secondary

Measure	Time frame
1) Progression free survival (PFS) 2) Overall survival (OS) 3) Adverse event rate 4) Pharmacogenetic analysis	—

Countries

Japan

Contacts

Public ContactShigehiro Yagishita

National Cancer Center Research Institute Division of Molecular Pharmacology

syagishi@ncc.go.jp0335422511

Outcome results