Non-small cell Lung Cancer
Conditions
Interventions
Induction therapy with platinum plus pemetrexed followed by maintenance therapy with pemetrexed until disease progression Induction therapy:CDDP 75mg/m2 day1 or CBDCA AUC6 day1+pemetrexed 500mg/m2 d
Sponsors
North Japan Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous NSCLC 2) Patients with EGFR wild type tumors 3) Unresectable NSCLC or reccurent NSCLC 4) Measurable brain and extra-brain lesions 5) Age: 20-75 6) ECOG performance status 1 or less 7) With adequate major organ functions within 14 days before randomization, as defined below: *Neutrophil count >= 2,000/mm3 *Platelet count >= 100,000/mm3 *Hemoglobin >= 9.0 g/dL *AST <= 2.0 x ULN *ALT <= 2.0 x ULN *Total bilirubin <= 1.5 mg/dL *Estimated CCr >= 45mL/min.(CBDCA) *Estimated CCr >= 60mL/min.(CDDP) *PaO2 >= 60 Torr or SpO2 >= 95% 8) Life expectancy more than 3 months 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastases 2) Radiotherapy for brain metastases 3) Interstitial lung disease or lung fibrosis detectable or chest X-ray 4) Taking systematic administration of steroid for more than 4 weeks 5) Pleural or cardiac effusion that needs to drain 6) Severe comorbidities 7) Active co-existent malignancies 8) Pregnant patients 9) Other conditions inadequate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate in brain lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Progression-free Survival Overall Survival Safety | — |
Countries
Japan
Contacts
Public ContactMakoto Maemondo
Dept. of Respiratory Medicine Dept. of Respiratory Medicine
Outcome results
None listed