Actively Recruiting
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trial
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
On this page
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Small cell lung cancer confirmed by pathology, with brain metastases diagnosed either at initial presentation or during treatment, and measurable disease according to RECIST criteria.
- Expected survival time of more than 3 months.
- Intracranial metastases count of 10 or fewer.
- Adequate organ and bone marrow function.
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after completion.
You will not qualify if you...
- Use of antiangiogenic drugs within the previous 1 month.
- Diagnosis of non-small cell lung cancer, including combined small cell carcinoma.
- Small cell lung cancer with hilar invasion or hemoptysis.
- Presence of acute or subacute intracranial cerebral infarction or hemorrhage.
- Unresolved acute toxic reaction higher than grade 2 from any prior treatment.
- Advanced disease with severe symptoms, internal organ spread, or high risk of life-threatening complications.
- Life-threatening conditions from other severe or uncontrolled diseases.
- History of prior brain radiotherapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants start oral anlotinib treatment 2 weeks before beginning whole-brain radiotherapy for brain metastases.
1 baseline visit before starting treatment
Duration - Whole-brain radiotherapy over approximately 2 to 4 weeks; anlotinib continues until tumor progression
Participants receive whole-brain radiotherapy combined with anlotinib treatment. Anlotinib is paused for 1 week after 2 weeks of treatment, then continued after radiotherapy until tumor progression.
Multiple visits for radiotherapy fractions and treatment monitoring
Duration - Up to 1 year or longer depending on outcomes
Participants are monitored for intracranial progression-free survival and other outcomes after treatment ends.
Periodic follow-up visits for assessment
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, China, 100004
Actively Recruiting
Research Team
L
Lei Deng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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