Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma

UMIN ID: UMIN000002014

Registered date:19/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Previously treated lung adeno carcinoma
• Date of first enrollment: 2009/06/01
• Target sample size: 560
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Reference arm Erlotinib monotherapy
B: Experimental arm Gefitinib monotherapy

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival, Response rate, disease control rate, Toxicity, Time to treatment failure,

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.) 5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 6)History of active infection 7)History of persistent watery diarrhea 8)History of ileus 9)Patients who are not take in drug orally 10)History of symptomatic brain metastases. 11)History of active double cancer 12)History of poorly controlled cardiac diseases. 13)History of active psychological disease. 14) History of pregnancy or lactation 15) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None