A Feasibility Study of Carboplatin/Paclitaxel/Nivolumab with Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Non-Small-Cell Lung Cancer
- Conditions
- nresectable locally advanced non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000032376
- Lead Sponsor
- Department of Thoracic Oncology, Kansai Medical University Hospiital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Double cancer 2) Interstitial pneumonia or pulmonary fibrosis 3) Diverticulitis or peptic ulcer 4) Severe lung disease, for example, emphysema, chronic bronchitis and bronchial asthma 5) Drug-induced interstitial pneumonia or severe drug allergy 6) Active tuberculosis or treatment history of tuberculosis 7) History of anaphylaxis induced by other antibody preparation 8) Uncontrollable diabetes 9) Active autoimmune disease 10) Peripheral neuropathy (>Grade 2) 11) Patients who received transplantation therapy 12) Patients who are receiving continuous systemic administration of steroids or immunosuppressants 13) The patient received or is scheduled to receive a live or attenuated vaccine within 28 days before the first dose of the investigational product 14) History of treatment for T cell regulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT): for 90 days from start of therapy
- Secondary Outcome Measures
Name Time Method 1) Safety: adverse events 2) Efficacy: response rate, progression free survival, overall survival, 2-year survival rate 3) Completion rate of therapy (concurrent phase)