PhaseIII study of gefitinib versus cisplatin plus docetaxel in patients with non-small cell lung cancer with EGFR mutation

UMIN ID: UMIN000000539

Registered date:11/12/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non small cell lung cancer
• Date of first enrollment: 2006/03/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Experimental arm Gefitinib (250mg/day) monotherapy until disease progression
B: Reference arm CDDP (80mg/sqm) day1, Docetaxel (60mg/sqm), q3w x 3-6 courses

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival Response

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Prior drug therapy targeting EGFR (TKI, Abs) 2. History of interstitial pneumonia or pulmonary fibrosis (Patients with radiation pneumonitis limited to radiation field are eligible) 3. History of severe drug allergy 4. History of active infection or other serious disease condition (GI bleeding, poorly controlled cardiac diseases, cirrhosis, ileus, persistant watery diarrhea, etc.) 5. History of symptomatic brain metastases. Brain metastases necessitating drug therapy for brain edema 6. History of poorly controlled pleural effusion 7. History of pericardial effusion or ascites necessitating drainage 8. History of active double cancer 9. History of severe hypersensitivity to polysolvate 80 containing drugs 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: West Japan Oncology Group
• Source(s) of Monetary Support: None