NCT07443397 Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
| NCT ID | NCT07443397 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Whole-Brain Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-08-29 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 134 participants in total. It began in 2025-08-29 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lei Deng, MD
STUDY CHAIR
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Frequently Asked Questions
Who can join the NCT07443397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Whole-Brain Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07443397 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 134 participants.
Is NCT07443397 currently recruiting?
Yes, NCT07443397 is actively recruiting participants. Contact the research team at dengleipumc@163.com for enrollment information.
Where is the NCT07443397 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07443397 clinical trial?
NCT07443397 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Lei Deng, MD at National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College. The trial plans to enroll 134 participants.