Non-small cell lung cancer
Conditions
Interventions
Cisplatin 80 mg/m2 is administered intravenously on day 1. Gemcitabine 1,000 mg/m2 is administered intravenously on days 1, 8. Treatment is repeated every 3 weeks for 4 cycles or up to 6 cycles by
s decision.
Carboplatin AUC 6 is administered intravenously on day 1. Nab-Paclitaxel 75mg/m2 is administered intravenously on days 1, 8, 15. Treatment is repeated every 3 weeks for 4 cycles or up
Sponsors
North Japan Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed squamous cell lung cancer. Non-small cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component are also acceptable. 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3) No prior chemotherapy (include EGFR-TKI and ALK inhibitor) *Adjuvant chemotherapy finished before 12 months or more from enrollment is permitted. *Picibanil use for plural effusion is permitted. 4) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.) 5) At least one measurable lesion (within 28 days before enrollment) 6) Age of 20 to 74 years 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 >= 60 mL/min (both permit measured CCr and estimated CCr) *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 gemcitabine and 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) Superior vena cava syndrome 6) Grade 2 or higher peripheral neuropathy 7) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 8) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 9)History of Severe drug allergies. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Progression-free Survival Disease Control Rate Incidence and Severity of Adverse Events | — |
Countries
Japan
Contacts
Public ContactYosuke Kawashima
Sendai Kousei Hospital Department of pulmonary medicine
Outcome results
None listed