Pulmonary Large-cell Neuroendocrine Carcinoma Clinical Trial
Official title:
A Multicenter Phase II, Single Arm Study of Durvalumab (MEDI 4736) With Carboplatin Plus Etoposide for 4 Cycles Followed by Durvalumab Maintenance in Patients With Metastatic Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)
A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC)
This is a prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC). Enrolled subjects will receive a combination of intravenous carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3), and durvalumab (1500 mg on day 1) administered every three weeks for a total of 4 courses (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit. Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit. ;