Advanced non-small cell lung cancer without EGFR mutation nor ALK fusion gene
Conditions
Interventions
weekly nab-Paclitaxel therapy
Sponsors
Kurashiki Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically proven NSCLC 2)Stage IIIb or IV 3)no EGFR mutation (exon19 deletion or L858R in exon 21) nor ALK fusion gene 4)two or three previous chemotherapy 5)age>20 6)ECOG PS 0-2 7)adequate organ function 8)expected survival days>90 9)written informed consesnt
Exclusion criteria
Exclusion criteria: 1)symptomatic brain metastasis 2)massive or uncontrolable pleural effusion 3)less than two weeks after palliative irradiation for bone metastases or the brain metastasis except the primary tumor 4)previous chemotherapy with paclitaxel or nab-paclitaxel 5)active concomitant malignancy 6)active infectious disease 7)severe comorbidity 8)history of severe drug allergy 9)continuous steroid therapy 10)phsychiatry disease 11)pregnant or lactating woman 12)HBs antigen positive 13)Peripheral neuropathy>CTCAE Grade2 14)interstitial pneumoia or active lung fibrosis on chest X-ray 15)Otherwise determined by the investigator to be unsuitable as a subject in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Response Rate, Adverse event, Quality of life, Difference in efficacy according to prior docetaxel therapy. | — |
Countries
Japan
Contacts
Public ContactTakashi Niwa
Kurashiki Central Hospital Department of Respiratory Medicine
Outcome results
None listed