Non-small cell lung cancer
Conditions
Interventions
Patients receive oral gefitinib 250mg once daily and carboplatin(AUC=5)/ pemetrexed(500mg/m2) on day1 every 3 weeks.
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3) EGFR mutation positive 4) At least one measurable lesion 5) No prior chemotherapy treatment 6) Age of 75 years or older 7) ECOG Performance status of 0-1 8) Sufficient major organ function 9) Life expectancy of at least 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis. 2) NSCLC harboring T790M mutation 3) No prior gefitinib or pemetrexed treatment as ajuvant/neoajuvant therapy. 4) Symptomatic brain metastases 5) Radiation therapy for primary site. 6) Severe concurrent disease 7) HBs antigen or HBc antibody or HBs antibody positive 8) Patient are treated with steroid continuously 9) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Active double cancer 12) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Disease Control Rate, Adverse Events, Overall Survival, QOL | — |
Countries
Japan
Contacts
Public ContactEisaku Miyauchi
Tohoku University Hospital Department of Respiratory Medicine
Outcome results
None listed