NCT07443397

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
18mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Aug 2025Dec 2027

Study Start

First participant enrolled

August 29, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Whole-Brain Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Intracranial progression-free survival

    Time from enrollment to intracranial tumor progression or death

    1 year

Secondary Outcomes (4)

  • Intracranial objective response rate (ORR) and disease control rate (DCR)

    1 year

  • Duration of intracranial response (DOR)

    1 year

  • Overall Survival (OS)

    2 year

  • CTCs level

    1 year

Study Arms (2)

Anlotinib+WBRT

EXPERIMENTAL

Oral Anlotinib plus whole-brain radiotherapy

Drug: AnlotinibRadiation: Whole-brain Radiotherapy

Control WBRT

OTHER

Only whole-brain radiotherapy

Radiation: Whole-brain Radiotherapy

Interventions

AnlotinibDRUG

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

Anlotinib+WBRT
Whole-brain RadiotherapyRADIATION

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.

Anlotinib+WBRTControl WBRT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100004, China

RECRUITING

MeSH Terms

Interventions

anlotinib

Study Officials

  • Lei Deng, MD

    National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

    STUDY CHAIR

Central Study Contacts

Lei Deng, MD

CONTACT

+86-010-87787625dengleipumc@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

August 29, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 2, 2026

Record last verified: 2025-12

Locations

CN(1)