Combining anlotinib with whole-brain radiotherapy for SCLC brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dengleipumc@163.com
• Phone: +86-010-87787625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.