Unresectable locally advanced non-small-cell lung cancer
Conditions
Interventions
Concurrent phase carboplatin, paclitaxel, nivolumab, thoracic radiotherapy Chemoeherapy (consolidation) <
optional>
carboplatin, paclitaxel, nivolumab Maintenance therapy nivolumab
Sponsors
Department of Thoracic Oncology, Kansai Medical University Hospiital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or Histologically confirmed unresectable locally advanced non-small-cell lung cancer 2) Clinical stage III, possible radical irradiation 3) Untreated by systemic anticancer therapy or thoracic radiotherapy 4) ECOG PS 0-1
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT): for 90 days from start of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety: adverse events 2) Efficacy: response rate, progression free survival, overall survival, 2-year survival rate 3) Completion rate of therapy (concurrent phase) | — |
Countries
Japan
Contacts
Public ContactTatsushi Goto
Secretariat of clinical trial coordinating committee none
Outcome results
None listed