Multicenter prospective observational study to evaluate immune cell dynamics of EGFR tyrosine kinase inhibitor re-administration after administration of immune checkpoint inhibitor in patients with relapsed / advanced non-small cell lung cancer with EGFR gene mutation

Multicenter prospective observational study to evaluate immune cell dynamics of EGFR tyrosine kinase inhibitor re-administration after administration of immune checkpoint inhibitor in patients with relapsed / advanced non-small cell lung cancer with EGFR gene mutation - A multicenter prospective observational study to evaluate immune cell dynamics of EGFR-TKI re-administration after ICI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039182

Enrollment

Registered

2020-01-17

Start date

2020-01-17

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

relapsed / advanced non-small cell lung cancer with EGFR gene mutation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Definitive diagnosis of non-small cell lung cancer has been obtained histologically or cytologically. 2) Patients with unresectable advanced / postoperative recurrent cancer of clinical stage III / IV. 3) EGFR gene mutation is found in tissue or cell samples. 4) Refractory to at least one or more regimens of EGFR-TKI therapy and cytotoxic anticancer drugs. 5) The immune checkpoint inhibitor was administered immediately and was discontinued due to exacerbation of the disease or adverse events. 6) The attending physician has determined that re-administration of EGFR-TKI is appropriate and will administer it. 7) Age at the time of registration is 20 years or older. 8) Performance status (ECOG classification) is 0 ~ 1. 9) Blood samples can be provided. 10) At least 3 months survival is expected. 11) Consent is obtained in writing regarding participation in this study.

Exclusion criteria

Exclusion criteria: 1) Patients with interstitial lung disease or a history of it. 2) HBs antigen positive. 3) HBs antibody or HBc antibody positive and HBV-DNA positive. 4) HCV carrier. 5) Serious complications. 6) A history of severe hypersensitivity. 7) The principal investigator or the research coordinator determined that participation in this study was inappropriate.

Design outcomes

Primary

Measure	Time frame
Changes in immune cell dynamics by EGFR-TKI administration	—

Countries

Japan

Contacts

Public ContactSho Takuma

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

takuma@hama-med.ac.jp053-435-2263

Outcome results