Durvalumab plus etoposide–carboplatin for advanced digestive neuroendocrine carcinoma: a phase III trial (JCOG2107E)

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Digestive neuroendocrine carcinoma (NEC) is a rare and highly aggressive malignancy, with an annual incidence of approximately 0.4–0.8 per 100,000 population. Due to its biological similarities with small cell lung cancer (SCLC), regimens such as etoposide plus cisplatin, irinotecan plus cisplatin, and etoposide plus carboplatin (EC) have been adopted as the standard treatments in unresectable or recurrent digestive NEC. However, its prognosis remains poor, thus requiring new treatment strategies. Immune checkpoint inhibitors plus cytotoxic chemotherapy have shown promise in the treatment of extensive-stage SCLC, warranting further exploration of their potential role in digestive NEC. An open-label randomized phase III investigator-initiated trial has been conducted since November 2023 to confirm the superiority of adding durvalumab to EC in chemotherapy-naive patients with unresectable or recurrent digestive NEC. A total of 74 patients will be enrolled from 14 institutions over 3 years. The primary endpoint is overall survival, while the secondary endpoints are progression-free survival, objective response rate, and incidence of adverse events.Clinical trial registration jRCT2031230456 (https://jrct.mhlw.go.jp/latest-detail/jRCT2031230456).