First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-

First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib- - First-Line Afatinib in Patients Aged 75 or Older

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017050

Enrollment

Registered

2015-04-10

Start date

2015-07-15

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

patients aged 75 or older with advanced non small cell lung cancer harboring EGFR mutation

Interventions

afatinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC) 2)Unresectable and metastatic NSCLC 3)Harboring sensitive EGFR mutation 4)Patients who have never treated with EGFR-TKI and cytotoxic chemotherapy. 5)More than 75 years old 6)Performance Status (ECOG) 0-1 7)Measurable lesion for RECIST(version 1.1) 8)Adequate organ functions 9)Life expectancy over 3 months 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy. 2)Preexisting interstitial lung disease of chest CT 3)HBs antigen positive 4)HBs or HBc antibody positive, and HBV-DNA positive 5)EGFR minor mutation or exon 20 T790M 6)Active double cancer 7)Digestive disease influencing absorption of afatinib 8)Oral feeding difficulty 9)Patients whose attending doctor consider as inappropriate for this study

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
disease control rate progression free survival overall survival Adverse events Quality of life PK/PGx	—

Countries

Japan

Contacts

Public ContactHidenori Mizugaki

Hokkaido University Hospital First department of medicine

mhide@med.hokudai.ac.jp011-706-5911

Outcome results

None listed

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