Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI.
- Conditions
- SCLC with previously treated EGFR-TKI.
- Registration Number
- JPRN-UMIN000006976
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
1. Patients could not received EGFR-TKI (gefitinib 250mg or erlotinib 150mg) more than evry 3 days. 2. History of symptomatic brain metastases. 3. History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. 4. History of radiation therapy for mediastinum or lung within 28 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 major surgery within 28 days. 7. History of active infection. 8. History of active double cancer 9. History of severe drug allergy 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
- Secondary Outcome Measures
Name Time Method