Study protocol of an open-label prospective phase II study of Durvalumab plus Carboplatin and Etoposide in advanced large cell neuroendocrine carcinoma of the lung (LOGIK2401: NECTAR study).

INTRODUCTION

Large cell neuroendocrine carcinoma (LCNEC) of the lung is a rare histologic type and is placed in the neuroendocrine tumor category along with small cell lung cancer (SCLC) at the latest histologic classification. Combination therapy with chemotherapy and immune checkpoint inhibitors is the standard of care for both non-small cell lung cancer and SCLC. However, the efficacy of immunochemotherapy for LCNEC has not yet been established.

METHODS AND ANALYSIS: This prospective, multicenter, single-arm study will evaluate the efficacy of durvalumab plus carboplatin and etoposide in patients with advanced or relapsed LCNEC. Thirty patients were enrolled in this study. Patients will receive durvalumab intravenously combined with up to four cycles of carboplatin and etoposide, followed by durvalumab maintenance treatment. The primary endpoint is the objective response rate, and the key secondary endpoints are the duration of response, progression-free survival, overall survival, and safety.

CONCLUSION

This is the prospective study to evaluate the efficacy of immunochemotherapy in patients with advanced or relapsed LCNEC. The results are expected to contribute to establishing the treatment strategy for LCNEC.