NIPH Clinical Trials Search

UMIN ID: C000000151

Registered date:09/09/2005

Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiednon-small cell lung cancer
Date of first enrollment2005/03/01
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)gefitinib 250mg/m2 /day orally


Primary Outcome(Primary Endpoint) Response rate
Secondary Outcome(Secondary Endpoint) Overall survival, One year survival, Time to progression, disease control rate, safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaIntestinal pneumonia or lung fibrosis 2) History of severe drug allergic reaction 3) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 4) Severe diarrhea 5) Bowel obstruction,ileus 6) Symptomatic brain metastasis 7) History of other malignancy 8) Pregnant women or women willing child-bearing 9) No regulatory condition because of psychological disease 10) Inadequate condition diagnosed by primary physician

Related Information


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Kenji Tamura MD
Address 1248-1, Otoda, Ikoma, Nara, 630-0293, Japan Japan
Telephone 0743-77-0880
Affiliation Kinki University School of Medicine, Nara Hospital Department of Medical Oncology