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Phase III Study of Anlotinib with Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-02
134
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining anlotinib, an oral drug, with whole-brain radiotherapy WBRT compared to WBRT alone in patients with small cell lung cancer SCLC who have brain metastases. This Phase III multicenter study also aims to understand how changes in circulating tumor cell CTC levels in the blood may relate to treatment response, helping to identify patients who could benefit most and potential biomarkers for treatment effects. Participants will be randomly assigned to receive either oral anlotinib plus WBRT or WBRT alone. Anlotinib treatment starts two weeks before radiotherapy, pauses for one week after two weeks, then continues after radiotherapy until tumor progression. WBRT involves a prescribed dose of at least 30 Gy over 10 fractions or 36 Gy over 20 fractions, with possible additional boosts for larger lesions. During the study, participants will be monitored for tumor response, survival, and changes in CTC levels over one to two years. Assessments will include measuring intracranial progression-free survival, objective response rates, disease control rates, duration of response, and overall survival. Safety and treatment effects will be closely tracked throughout the study period, which begins in August 2025 and ends in December 2027.
CONDITIONS
Brief Title
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
Research Team
L
Lei Deng, MD
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