A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.

A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment. - A biomarker analysis of Afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025126

Enrollment

Registered

2016-12-03

Start date

2016-07-20

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-T790M positive non-small-cell lung cancer relapsed after 3rd generation EGFR-TKI

Interventions

Consecutively administer oral dose of afatinib at 40 mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)EGFR mutation-poasitive lung adenocarcinoma 2)T790M mutation was detected after EGFR-TKI treatment, and refractory to 3rd generation EGFR-TKI 3)Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 4)with evaluable lesion based on RESIST 5)written informed consent

Exclusion criteria

Exclusion criteria: 1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer). 2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan. 3) Symptomatic brain metastasis (clinically stable brain metastasis is eligible) 4) HBs antigen-positive 5) Infection requiring systemic treatment 6) Patients who, in the opinion of the attending physician, are inappropriate for the study

Design outcomes

Primary

Measure	Time frame
Detection of biomarker for afatinib treatment in patients with relapse of EGFR-T790M mutation-positive advanced lung adenocarcinoma after 3rd generation EGFR-TKI treatment	—

Secondary

Measure	Time frame
progression free survival, response rate, safety	—

Countries

Japan

Contacts

Public ContactHidenobu Ishii

Kurume University School of Medicine Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine

ishii_hidenobu@med.kurume-u.ac.jp0942-31-7560

Outcome results

None listed

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