Prediction of adverse events in patients with EGFR-mutant non-small cell lung cancer using population pharmacokinetics of afatinib

Prediction of adverse events in patients with EGFR-mutant non-small cell lung cancer using population pharmacokinetics of afatinib - Population pharmacokinetics of afatinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014181

Enrollment

Registered

2014-06-06

Start date

2014-07-25

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

EGFR-mutant non-small cell lung cancer

Interventions

Patients are treated with afatinib and serial blood samples are collected (drug concentrations and T790M mutation are investigated)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria are as follows: (1) patients with EGFR-mutant non-small cell lung cancer adaptable to afatinib; (2)with written informed consent.; (3) without infection of HIV, HTLV, HBV, HCV, and TP.

Exclusion criteria

Exclusion criteria: Unsuitable cases are whom doctors jugde unable to be carried out this research safely.

Design outcomes

Primary

Measure	Time frame
correlation of adverse event and efficacy with plasma concentration of afatinib	—

Secondary

Measure	Time frame
correlation of response rate and progression-free survival with plasma concentration of afatinib, correlation of adverse event and efficacy with T790M mutation	—

Countries

Japan

Contacts

Public ContactKeiko Nakao

National Hospital Organization Kinki-chuo Chest Medical Center Department of Internal Medicine

keinakao@kch.hosp.go.jp072-252-3021

Outcome results

None listed

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