NCT07510594

A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC

A Single-Center, Single-Arm, Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as First-Line Treatment for Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC)

Detailed description

This study is a single-center, single-arm, phase II study designed to observe and evaluate Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma (LCNEC) of the lung and extrapulmonary neuroendocrine carcinoma (EP-NEC). Enrolled patients are those with histologically or pathologically confirmed metastatic LCNEC or EP-NEC (AJCC 9th edition) who have not received systemic treatment. Eligible subjects will receive 4 cycles of Benmelstobart combined with Anlotinib and chemotherapy, followed by maintenance treatment with Benmelstobart combined with Anlotinib, with continuous medication until disease progression or intolerable toxicity. The purpose of this study is to evaluate the efficacy and safety of Benmelstobart Injection combined with Anlotinib Hydrochloride and chemotherapy as first-line treatment for advanced LCNEC and EP-NEC.

Conditions

• Large-Cell Neuroendocrine Carcinoma of the Lung
• Extrapulmonary Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Benmelstobart+ Anlotinib+ Platinum + Etoposide	Treatment phase (intensive combination treatment) : 4 cycles, with each treatment cycle lasting 21 days: 1) Benmelstobart: 1200mg per dose, administered intravenously (IV) once every 21 days; 2) Anlotinib: 12mg per dose, taken orally (po) for 2 consecutive weeks followed by 1 week of rest; 3) Carboplatin: administered on Day 1, with an AUC of 5mg/mL/min via IV infusion (maximum dose: 750mg); \& Cisplatin: administered on Day 1, 75-80mg/m² via IV infusion; 4) Etoposide: administered continuously on Days 1, 2, and 3, 100mg/m² via IV infusion; Maintenance phase: 1) Maintenance treatment will be continued until loss of clinical benefit, intolerable toxicity, efficacy evaluation of PD, or judgment by the investigator that continued medication is inappropriate; 2) Benmelstobart: 1200mg per dose, administered IV once every 21 days; 3) Anlotinib: 12mg per dose, taken orally for 2 consecutive weeks followed by 1 week of rest.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China