Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.
- Conditions
- SCLC
- Registration Number
- JPRN-UMIN000010709
- Lead Sponsor
- Hanshin-Saga Collaborative Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1. Prior chemotherapy or other systemic anti-cancer treatment (excluding EGFR TKIs). 2. Not considered to require radiotherapy to the lung at the time of study entry or in the near future. 3. Patients with past history of acute lung disorder or interstitial pneumonia, drug-induced interstitial disease or radiation pneumonitis requiring steroid therapy. Or those presenting the signs of comorbidity of acute disorder or interstitial pneumonia, or those having clear interstitial pneumonia or pulmonary fibrosis on chest CT. 4. Patients with large amount of or uncontrollable pleural effusion/ascites/pericardial fluid. 5. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy. 6. Patients with past history of serious drug allergy. 7. Concomitant use of CYP3A4 inducers eg phenytoin, carbamazepine, rifampicin, barbiturates or St John's Wort. 8. Patients with serious infectious disease or other serious complications. 9. As judged by the investigator, any evidence of severe or uncontrolled systemic disease. 10. Patients with complication by poorly controllable diabetes mellitus. 11. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication. 12. Patients with active double cancer. Or those who have been diagnosed as having malignant tumor within the past 5 years. 13. Patients with clinically problematic mental disorder, etc. 14. Patients who are pregnant, lactating or may be pregnant, or those who have no intention of contraception. 15. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. 16. Patients who are involved in the planning and practice of this study. 17. Previous enrolment or treatment in the present study. 18. Other patients who have been judged by attending physicians, etc. as being inappropriate for safe conduction of this study.
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 rate, Disease control rate, and safety