Advenced non-small cell lung cancer immediately after immune checkpoint inhibitors failure
Conditions
Interventions
Chemotherapy
Sponsors
Third department of internal medicine, Universtiy of Fukui
Japanese Red Cross Fukui Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with non-small cell lung cancer within 12 weeks after immune checkpoint inhibitors therapy (including anti PD-1 antibody, anti PD-L1 antibody, and immune checkpoint inhibitors combination with cytotoxic agents). 2) Patient with evaluable lesion based on RECIST. 3) Age 20 or over. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5) No severe organ dysfunction and laboratory data fulfill the standards. 6) Three months and more survival is expected. 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Allergy or hypersensitibity against the medicines in this trial or albumin. 2) Patients who previously treated with paclitaxel or nab-paclitaxel. 3) Peripheral neuropathy (grade 2 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion. 5) Thoracic radiotherapy after initiation of immune checkpoint inhibitors, and within 2 weeks after radiotherapy for lesions except primary lesion. 6) Operation within 4 weeks. 7) Active double cancer. 8) High body temperature (38 degrees Celsius and more). 9) Severe complications including heart failure, hepatic failure, and renal failure. 10) Pregnant woman. 11) HBs antigen positive. 12) The subjects whom the doctor excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, disease control rate, overall survival, and saftey. Subset analysis of efficacy stratified by histological subtype, presense of driver mutations (EGFR/ALK/ROS1), smoking history, and degree of tumor PD-L1 expression. | — |
Countries
Japan
Contacts
Public ContactYukihiro Umeda
University of Fukui Third department of internal medicine
Outcome results
None listed