NSCLC
Conditions
Interventions
Administer gefitinib continuously at the dose of 250 mg, in principle, once daily until the discontinuation criteria are fulfilled. Administer pemetrexed by intravenous drip infusion at the dose of 50
Sponsors
Hanshin-Saga Collaborative Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as having non small cell lung cancer by biopsy or cytology. 2. Stage IIIB or IV,in which radical irradiation is impossible, or postoperative recurrence. 3. Harboring EGFR mutation (exon 19 deletion, exon 21 L858R) 4. Clinical efficacy (CR PR SD and above 6 months) has already been obtained by administration of gefitinib as the first line treatment. 5. Gefitinib has already been administered as the first line treatment for above 6 months. 6. PD has been confirmed by imaging within 4 weeks prior to participation in this clinical study during the period of continuous administration of gefitinib as the first line treatment. However, when no PD findings have been confirmed in regions other than the head, such patients are judged as being ineligible as study subjects at that time point. 7. Subject with lesions evaluable by RECIST criteria. 8. Age at the time of obtaining informed consent is over 20 years. 9. ECOG Performance status (PS) is 0 to 2. 10. Major organ functions satisfying. 11. Survival for and above 12 weeks from the day of start of administration is expected. 12. Written consent has been obtained from patients themselves after adequate explanation of the study contents prior to their registration in this study. Particularly, patients who reject to receive platinum combination therapy after they have been explained that such switchover is the standard treatment, when they have been progressed by the first-line treatment with gefitinib.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Response rate, Disease control rate, and safety | — |
Countries
Japan
Contacts
Public ContactKen Uchibori
Tokyo Medical and Dental University Department of Respirology
Outcome results
None listed