Non-Small Cell Lung Cancer
Conditions
Interventions
Level 1:carboplatin AUC 6+nab-paclitaxel,4cycles Level 0:carboplatin AUC 5+nab-paclitaxel,3cycles If 3 or more of the first 6 patients who had been originally allocated to the level 1 experienced
Sponsors
National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histology/cytology-proven non-small cell lung cancer 2)No prior treatment 3)Stage IIIB, IV and unsuitable for radiotherapy 4)EGFR(-),ALK(-) 5)PD-L1 staining:1%-49% 6)With one or more measurable disease based on RECIST 7)Performance status(ECOG): 0-1 8)Age 20<80 9)Adequate organ function 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia/lung fibrosis on chest X-ray 2) History of chest radiation therapy 3) Auto-immuno disease patients 4) Receiving steroid therapy 5) Symptomatic brain metastasis 6) Active hepatic disease 7) Having serious complications 8) Uncontrolled ascites, pleural effusion or cardiac effusion 9) History of multiple malignancies within 3 years 10) Planning of surgery during the trial 11) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy, and 12) Having serious mental disorder 13) Previous drug allergy 14) Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of nivolumab maintenance therapy after carboplatine plus nab-paclitaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tumor efficacy | — |
Countries
Japan
Contacts
Public ContactMasao Ichiki
National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Outcome results
None listed