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

NCT07510594 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-03

No results posted yet for this study

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)

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510594 on ClinicalTrials.gov