Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)

Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM) - Phase II study of low-dose afatinib for elderly NSCLC patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022252

Enrollment

Registered

2016-05-10

Start date

2016-08-04

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

Non-small cell lung cancer

Interventions

1) Treatment with afatinib at a dose of 20 mg daily (until PD). 2) At day 7-14 after the start of afatinib, samples for pharmacokinetc analyses will be obtained (9 points). 3) Afatinib were permitte

15 ng/mL at day 7-14.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmation of non small cell lung cancer 2) Clinical stage IIIB, IV, or postoperative recurrence 3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21) 4) ECOG performance status 0-2 5) No prior therapy of EGFR-TKI 6) Measurable lesions based on RECIST ver1.1 7) Adequate organ functions 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Interstitial lung disease 2) Receiving continuous systemic corticosteroid 3) During pregnancy or lactation 4) Psychological disorder difficult to participate in this clinical study

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response rate, Overall survival, Incidence of adverse events, PK analysis	—

Countries

Japan

Contacts

Public ContactHirotsugu Kenmotsu

Shizuoka Cancer Center Division of Thoracic Oncology

h.kenmotsu@scchr.jp055-989-5222

Outcome results

None listed

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