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

UMIN ID: C000000184

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 2004/11/01
• Target sample size: 16
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gefitinib 250mg/day, until disease progression

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Toxicity Survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Hokkaido Lung Cancer Clinical Study Group
• Source(s) of Monetary Support: None