Multicenter, prospective observational study to identify peripheral blood-derived epigenome markers correlated with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients

Multicenter, prospective observational study to identify peripheral blood-derived epigenome markers correlated with blood trough value and adverse events of afatinib in EGFR mutation-positive non-small cell lung cancer patients - Afatinib PEGx study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030939

Enrollment

Registered

2018-01-27

Start date

2018-01-12

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

Lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed diagnosis of non-squamous cell and non-small cell lung cancer Stage IIIB or Stage IV advanced unresectable, postoperative recurrent cancer Using afatinib as first line treatment Age more than 20 years at screening ECOG performance status 0-1 The function of organs(marrow, liver, kidney, etc.) is maintained enough Life expectancy more than 3 months Writing consent is obtained

Exclusion criteria

Exclusion criteria: Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated Active other malignancy HBs antigen positive HBs or HBc antibody positive and HBV-DNA positive HIV or HCV carrier Adjuvant chemotherapy Infection to need to treat with antibiotics or antifungal agent via intravenous administration Not obtain the consent of taking the sample Serious psychiatric disorder Women who are pregnant, nursing, or who plan to become pregnant and Men who plan to father a child while in this study.

Design outcomes

Primary

Measure	Time frame
To identify peripheral blood epigenome marker correlation with blood trough value and adverse events of afatinib	—

Countries

Japan

Contacts

Public ContactTetsuya Oguri

Nagoya City University Graduate School of Medical Sciences Department of Respiratory Medicine, Allergy and Clinical Immunology

t-oguri@med.nagoya-cu.ac.jp085-853-8216

Outcome results