Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations

Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations - Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000184

Enrollment

Registered

2005-09-12

Start date

2004-11-01

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 250mg/day, until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically proved NSCLC 2.EGFR mutation positive 3.No prior chemotherapy 4.Stage IIIB or IV disease 5.Measurable disease on RECIST criteria 6.ECOG PS 0 to 2 7.20 or more than 20 years of age 8.Normal organ functions 9.Anticipated survival at least 3 months 10.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Serious concomitant systemic disorders 2.Uncontrollable angina, acute myocardial infarction or severe heart failure within 3 months 3.Uncontrollable diabetes mellitus or hypertension 4.Active infection 5.Interstitial pneumonia 6.Uncontrollable pleural effusion 7.Active ulcer 8.Active second malignancy 9.History of severe hypersensitivity 10.Severe SVC syndrome 11.Pregnancy 12.Other severe complication

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Toxicity Survival	—

Countries

Japan

Contacts

Public ContactKoichi Yamazaki

Hokkaido Lung Cancer Clinical Study Group First Department of Medicine, Hokkaido University School of Medicine

kyamazak@med.hokudai.ac.jp011-706-5911

Outcome results

None listed

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