A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations

A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations - A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002783

Enrollment

Registered

2009-11-19

Start date

2007-09-01

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

lung adenocarcinoma

Interventions

gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histopathologically diagnosed as primary lung adenocarcinoma 2)including the mutation in exon 19 or 21 3)confirmed advanced stage 3B or 4 lung adenocarcinoma 4)75 years or older 5)ECOG PS 0-2 6)measurable lesion 7)adequate organ function 8)predicted 12 weeks or more survival 9)informed consent

Exclusion criteria

Exclusion criteria: 1)interstitial pneumonia on computed tomography scan 2)liver cirrhosis, uncontrolled diabetes mellitus, cardiac infarciton and cereral apoplexy onset within three months 3)othere active cancer 4)symptomatic brain metastases 5)need to plan the radiotherapy included in the lung field 6)history of sever drug allegy 7)judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
safety, disease control rate, progression free survival overall survival, quality of life	—

Countries

Japan

Outcome results

None listed

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