National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100004, China
Location status: Recruiting
Recruiting
NCT Number: NCT07443397
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Anlotinib
DrugOral 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
Whole-Brain Radiotherapy
RadiationPrescription 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.
Primary outcomes
-
Intracranial progression-free survival
Time frame: 1 year
Time from enrollment to intracranial tumor progression or death
Secondary outcomes
-
Intracranial objective response rate (ORR) and disease control rate (DCR)
Time frame: 1 year
ORR (Objective Response Rate): The proportion of patients whose tumors shrink significantly (either completely or partially) after treatment.
DCR (Disease Control Rate): The proportion of patients whose tumors either shrink or remain stable (i.e., do not progress) after treatment.
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Duration of intracranial response (DOR)
Time frame: 1 year
The length of time from when a patient first achieves tumor response (CR or PR) until disease progression or death.
-
Overall Survival (OS)
Time frame: 2 year
The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up.
-
CTCs level
Time frame: 1 year
Levels of circulating tumor cells (CTCs) in peripheral blood.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Registry information
Official study title
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 2, 2026
- Registry last updated
- Mar 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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