advanced NSCLC
Conditions
Interventions
Nivolumab 1200mg (day 1, q3 weeks) until clinical progression or unacceptable toxicities
Sponsors
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Definitively diagnosed with having previously treated advanced non-small cell lung cancer by the specimens histologically or cytologically who have no indication for standard treatment of chemotherapy including cytotoxic chemotherapy and molecular targeted agents for driver mutation. 2) Age of 20 years and older 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) PS 2-4 (2) neutrophil count => 500/mm^3 (3) platelet => 50,000/mm^3 (4) hemoglobin => 8.0g/dL (5) AST/ALT < 5 times less than ULN (6) T.Bil <= 3.0mg/dL (7) serum creatinine <= 3.0mg/dL (8) ECG: without clinically problematic abnormalities (9) SpO2 more than 92% 4) With the status of below previous treatment at the time of beginning of chemotherapy. (1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation (2) Surgical procedure, including pleurodesis or pleural drainage * more than 8 weeks with lobectomy * more than 4 weeks without lobectomy, including exploratory thoracotomy * more than 2 weeks after completing procedure (pleurodesis or pleural drainage) 5) With written informed consent
Exclusion criteria
Exclusion criteria: 1) The age of less than 20 2) Indicative for cytotoxic chemotherapy or molecular targeted agents 3) Uncontrolled brain metastasis treated by palliative radiotherapy 4) Clinically active infection 5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) Uncontrolled pleural effusion 7) Active other organ cancers 8) History of severe drug allergy 9) Uncontrolled digestive ulcer 10) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, and Toxicity. AND, we will explore serum or blood-based biomarker analysis and immune state as the accompanying research with the informed consent | — |
Countries
Japan
Contacts
Public ContactOkuma Yusuke
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital Department of Respiratory Medicine and Thoracic Oncology
Outcome results
None listed