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

Phase 3

• Conditions: non small cell lung cancer

• Registration Number: JPRN-UMIN000000539
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-11
• Study Completion: 2011-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival Response