A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung

A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung - A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006144

Enrollment

Registered

2011-08-12

Start date

2005-02-01

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

Adenocarcinoma of the lung

Interventions

Gefitinib treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven adenocarcinoma of the lung 2) Chemotherapy-naive patients 3) Stage IIIB, not candidate for curative radiotherapy or stage IV including recurrence disease after surgery 4) Aged 70 years or older 5) Measurable disease 6) ECOG performance status of 0-2 7) Adequate organ function 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Concomitant serious medical conditions 2) Interstitial lung disease or pulmonary fibrosis detected by conventional computed tomography of the chest 3) Massive pleural or pericardial effusion or ascites that required drainage, superior vena caval syndrome or symptomatic brain metastasis 4) History of serious drug allergy 5) Previous radiotherapy to the primary tumor 6) Other concurrent active malignancy 7) Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease control rate, median survival time, 1-year survival rate, progression-free survival time and adverse events	—

Countries

Japan

Contacts

Public ContactHiroshi Saito

Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine

hsaito@acc-aichi.com0564-21-6251

Outcome results

None listed

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