Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancer

UMIN ID: UMIN000002314

Registered date:11/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Previously treated non-small cell lung cancer
• Date of first enrollment: 2009/08/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival,response, safety, and analysis of EGFR mutation using tumor sumples

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)History of obvious distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT (Patients with radiation peumonitis limited to radiation field are eligible) 2)History of obvious drug induced interstitial pneumonia or pneumoconiosis 3)History of symptomatic brain metastases. Patients with brain metastases are eligible, if thier brain metastases are controlled by radiotherapy or drug therapy. 5)History of severe drug allergy 6)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 7)History of active infection or other serious disease condition (poorly controlled diabetes mellitus, poorly controlled cardiac disease, GI bleeding, cirrhosis, ileus, persistant watery diarrhea, etc) 8)History of active double cancer 9)History of active psychological disease. 10) History of pregnancy or lactation 11) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: National Hospital Organization Headquarters Center for Support and Education of Clinical Research
• Source(s) of Monetary Support: National Hospital Organization Headquarters Center for Support and Education of Clinical Research