A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.

A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations. - First-Line Gefitinib for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001863

Enrollment

Registered

2009-04-08

Start date

2009-04-01

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

Gefitinib treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Chemotherapy-naive patients with non-small-cell lung cancer 2) Stage IIIB or IV 3) Patients having EGFR mutation (exon 19 deletion or L858R) 4) Patients aged 70 years or older 5) Measurable lesion 6) ECOG performance status 0 to 2 7) Adequate organ function 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active infection, uncontrolled heart disease or diabetes mellitus 2) Interstitial pneumonia / pulmonary fibrosis on computed tomography scan 3) Massive pleural or pericardial effusion, or ascites 4) Superior vena cava syndrome 5) Symptomatic brain metastases 6) Severe drug allergy 7) Previous radiotherapy to the primary tumor 8) Postoperative adjuvant therapy 9) Other concurrent active malignancy 10) Pregnant or breast-feeding woman

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, Quality of life, Adverse events	—

Countries

Japan

Contacts

Public ContactKosuke Takahashi

Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine

0564-21-6251

Outcome results

None listed

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