Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study

UMIN ID: C000000408

Registered date:24/04/2006

Basic Information

• Health condition(s) or Problem(s) studied: non small cell lung cancer with EGFR mutation
• Date of first enrollment: 2006/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral administration of 250 mg/day of gefitinib

Outcome(s)

• Primary Outcome: tumor response rate
• Secondary Outcome: 1)Adverse events 2)Progression free-survival 3)Overall survival

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)EGFR mutations except exon19 deletion and exon21 mutation (L858R) or double mutation. 2)Serious infectious disease 3) Brain metastases requiring treatment 4) Serious concomitant disease 5) Ascites, pleural or pericardeal effusion requiring drainage 6)Pregnant or lactation women, or women with known or suspected pregnancy 7) Apparent ineterstitial pneumonia or pulmonary fibrosis 8) Prior treatment of gefitinib 9) Requiring emergency radiotherapy Cardiac infarction within 6 month 10)Inappropriate patients for this study judged by the physicians

Related Information

• Primary Sponsor: Okayama University Cancer and Thoracic Surgery
• Source(s) of Monetary Support: N/A