NCT07443397

Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.

Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, prospective Phase III study to evaluate the efficacy and safety of anlotinib plus whole-brain radiotherapy (WBRT) compared with WBRT alone in small cell lung cancer (SCLC) patients with brain metastases. Additionally, by investigating the association between changes in circulating tumor cell (CTC) levels in peripheral blood and treatment response to the combination of targeted therapy and radiotherapy, we aim to identify a patient subgroup most likely to benefit from this regimen, as well as potential biomarkers predictive of treatment efficacy.

Conditions

• Whole-Brain Radiotherapy

Interventions

Type	Name	Description
DRUG	Anlotinib	Oral anlotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression
RADIATION	Whole-brain Radiotherapy	Prescription dose: Whole-brain irradiation with a minimum of 30 Gy in 10 fractions or 36 Gy in 20 fractions. Lesions larger than 5 mm in diameter may receive a simultaneous or sequential boost.

Timeline

• Start date: 2025-08-29
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China