NCT07443397RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 29 Aug 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT07443397
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 134
- From 29 Aug 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have used antiangiogenic drugs within the previous 1 month.
- An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
- History of prior brain radiotherapy.
Other illness
- 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.
- Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
Other
- Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.