Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel 75mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks. Carboplatin AUC 6 is administered by an infusion lasting 30-60 minutes on day 1 following to n
Sponsors
North Japan Lung Cancer Study Group
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) No prior chemotherapy *Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted. *Picibanil use for plural effusion is permitted. *EGFR-TKI and ALK inhibitor use for each driver mutation is permitted. 4) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.) 5) At least one measurable lesion 6) Age of 75 years or older 7) ECOG Performance status of 0-1 8) Sufficient major organ function as bellow *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *total bilirubin <= 1.5 mg/dL *AST <= 100 IU/L *ALT <= 100 IU/L *Serum creatinine <= 1.5 mg/dL *Creatinine clearance >= 40 mL/min *PaO2 >= 60 Torr or more (or SpO2 >= 95% or more) 9) Life expectancy of at least 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previous treatment with paclitaxel as adjuvant chemotherapy 2) Active double cancer 3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Grade 2 or higher peripheral neuropathy 6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 7) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 8) History of Severe drug allergies. 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Countries
Japan
Contacts
Public ContactEisaku Miyauchi
Tohoku University Hospital Clinical Research, Innovation and Education Center
Outcome results
None listed