Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy

Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy - Phase II study of EGFR-TKI in elderly patients with lung cancer harboring EGFR gene mutation in liquid biopsy (ALCSG-03)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025624

Enrollment

Registered

2017-02-01

Start date

2017-02-01

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

Single agent Erlotinib or Gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility includes; (1) Patients of lung cancer diagnosed with CT imaging by respiratory medicine specialist (2) Patients harboring EGFR gene mutation Exon19 deletion or L858R in liquid biopsy with Cobas ver2.0. (3) Clinical stage from IIIA toIV. (4) Patients aged 70 and over 70 years. (5) Patients who are not treated with EGFR-TKI previously. (6) Patients who can take EGFR-TKI orally. (7) Patients having adequate organ function. (8) Letter of consent

Exclusion criteria

Exclusion criteria: Patients are excluded if they have; (1) Severe concomitant disease. (2) Severe history of hypersensitivity. (3) Severe heart disease or arrhythmia. (4) Interstitial pneumonia. (5) Active infection. (6) Active peptic ulcer. (7) Active double cancer. (8) No measurable lesion.

Design outcomes

Primary

Measure	Time frame
Response rate.	—

Secondary

Measure	Time frame
Safety, progression free survival, overall survival.	—

Countries

Japan

Contacts

Public ContactRyohei Yoshida

Asahikawa Medical University Hospital Respiratory Center

yryohei@asahiakwa-med.ac.jp0166-69-3290

Outcome results

None listed

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