Sequential therapy from afatinib to osimertinib for EGFR-mutant non-small cell lung cancer: a multicenter prospective observational study (Gio-Tag Japan)

A observational study to evaluate afatinib followed by osimertinib - Afa-Osi for EGFR-mutant NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037452

Enrollment

120

Registered

2019-07-22

Start date

2019-08-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Histologically or cytologically conformed NSCLC 3. EGFR-mutant (Del-19 or L858R) 4. Advanced disease without indication of surgery and CRT 5. Afatinib will be administered as the first-line therapy 6. Aged older than 20 7. PS (ECOG) 0/1

Exclusion criteria

Exclusion criteria: 1. Active double cancer 2. No interstitial lung disease 3. No uncontrolled comorbidities

Design outcomes

Primary

Measure	Time frame
Time on treatment of afatinib followed by osimertinib	—

Secondary

Measure	Time frame
OS, RR/PFS of afatinib, RR/PFS of osimertinib, efficacy of afatinib by dosages, incidence of rebiopsy, positive-rate of T790M by cobas, positive-rate of T790M by ddPCR, TOT of afatinib followed by chemotherapy other than osimertinib, and TD-TKI	—

Countries

Japan

Contacts

Public ContactAkito Hata

Kobe Minimally Invasive Cancer Center Department of Thoracic Oncology

akitohata@hotmail.com078-304-4100

Outcome results