NCT06931145

Benmelstobart, Anlotinib and Chemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

A Real-world Study of Benmelstobart, Anlotinib and Chemotherapy Regimen as First-line Treatment for Extensive-stage Small-cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Benmelstobart	Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously.
DRUG	Anlotinib	Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week. During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events.
DRUG	Carboplatin or cisplatin	Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV.
DRUG	Etoposide	Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV.

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-04-30
• Completion: 2027-12-31
• First posted: 2025-04-17
• Last updated: 2025-04-23

Locations

1 site across 1 country: China