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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
134 participants
Aug 29, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
- The expected survival time is more than 3 months.
- Intracranial metastases ≤10.
- Adequate organ and bone marrow function.
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion.
Exclusion Criteria8
- Patients who have used antiangiogenic drugs within the previous 1 month.
- Non-small cell lung cancer (including combined small cell carcinoma).
- Small cell lung cancer with hilar invasion or hemoptysis.
- Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
- An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
- Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
- Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
- History of prior brain radiotherapy.
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Interventions
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
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.
Locations(1)
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NCT07443397