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.

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.

Study Overview

• Status: Recruiting
• Conditions: Whole-Brain Radiotherapy
• Intervention / Treatment: Drug: Anlotinib; Radiation: Whole-brain Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lei Deng, MD; Phone Number: +86-010-87787625; Email: dengleipumc@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100004
      • Recruiting
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
      • Contact: Lei Deng, MD; Phone Number: +86-010-87787625

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib+WBRT; Oral Anlotinib plus whole-brain radiotherapy	Drug: Anlotinib; Oral 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; Radiation: Whole-brain Radiotherapy; Prescription 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.
Other: Control WBRT; Only whole-brain radiotherapy	Radiation: Whole-brain Radiotherapy; Prescription 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial progression-free survival	Time from enrollment to intracranial tumor progression or death	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial objective response rate (ORR) and disease control rate (DCR)	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.	1 year
Duration of intracranial response (DOR)	The length of time from when a patient first achieves tumor response (CR or PR) until disease progression or death.	1 year
Overall Survival (OS)	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.	2 year
CTCs level	Levels of circulating tumor cells (CTCs) in peripheral blood.	1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Lei Deng, MD, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: anlotinib
• Other Study ID Numbers: NCC5213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No