Combining anlotinib with whole-brain radiotherapy for SCLC brain metastases

Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.

This trial will test whether adding the targeted drug anlotinib to whole-brain radiotherapy helps people with small cell lung cancer who have brain metastases.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: anlotinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07443397 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, prospective Phase III trial that compares anlotinib plus whole-brain radiotherapy (WBRT) versus WBRT alone in patients with small cell lung cancer (SCLC) and brain metastases. Patients must have measurable intracranial disease (up to 10 metastases), adequate organ function, and an expected survival greater than three months. The study will record safety and efficacy outcomes and will prospectively measure circulating tumor cell (CTC) levels to explore whether changes in CTCs predict which patients benefit most from the combination. The trial aims to identify both clinical benefit and potential blood-based biomarkers linked to response.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed SCLC and measurable brain metastases (≤10 lesions), adequate organ and marrow function, expected survival >3 months, and no recent antiangiogenic therapy.

Not a fit: Patients with non-small cell histology, recent intracranial hemorrhage or acute cerebral infarction, uncontrolled severe systemic disease, or recent use of antiangiogenic drugs are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could improve intracranial tumor control and delay neurological progression compared with radiotherapy alone.

How similar studies have performed: Earlier-phase studies and trials combining antiangiogenic agents with radiotherapy have shown signals of improved local control in some cancers, but randomized Phase III evidence specifically for anlotinib plus WBRT in SCLC brain metastases is limited.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lei Deng, MD

Conditions Whole-Brain Radiotherapy