Small cell lung cancer
Conditions
Interventions
Patients will receive etoposide (=75 years old: 80mg/m2
intravenously on day 1-3), carboplatin (area under the curve 5 mg/mL intravenously on day 1), and durvalumab (1500mg/body intravenously on day1) every three weeks for four cycles. Thereafter, patients
Sponsors
Fujimoto Daichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria are as follows: 1) patients who have unresectable extensive disease, 2) patients whose tumor is histologically or cytologically confirmed small cell lung cancer, 3) patients aged >=20 years, 4) patients with Eastern Cooperative Oncology Group performance status of 0 to 1, 5) patients have no previous chemotherapy or immune checkpoint inhibitor for small cell lung cancer, 6) patients with chronic fibrotic IP, 7) patients diagnosed as Probable UIP pattern, Indeterminate for UIP pattern, and Alternative diagnosis pattern according to the ATS/ERS/JRS/LATS association official guidelines, and 8) patients with adequate organ function.
Exclusion criteria
Exclusion criteria: Key exclusion criteria are as follows: 1) any history of previous malignancy in the past 5 years, 2) any history of autoimmune disease (patients who have controlled thyroid dysfunction or skin disease that does not require systemic therapy eligible), 3) %VC <80%, 4) patients diagnosed as definite UIP pattern, 5) other interstitial lung disease including connective tissue disease-ILD, pneumoconiosis, and drug-induced pneumonitis, 6) history of taking corticosteroid, other immunosuppressive drug, pirfenidone, and nintedanib within 14 days before registration, and 7) patients with symptomatic brain metastasis or meningeal carcinomatosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe_pneumonitis-free rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, time to treatment failure, time to pneumonitis, and rate of adverse events | — |
Contacts
Public ContactRyota Shibaki
Wakayama Medical University Hospital
Outcome results
None listed