Whole-Brain RadiotherapyPhase 3NCT07443397
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
A Phase 3 study testing Anlotinib and Whole-brain Radiotherapy in people with Whole-Brain Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Whole-Brain Radiotherapy
- What is being tested?
- Anlotinib and Whole-brain Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100004
Lei Deng, MD, +86-010-87787625
About this study
Official title: 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.
- Conditions
- Whole-Brain Radiotherapy
- Being tested
- Anlotinib, Whole-brain Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+WBRT | Experimental | Oral Anlotinib plus whole-brain radiotherapy Receives: Drug: Anlotinib; Radiation: Whole-brain Radiotherapy |
| Control WBRT | Other | Only whole-brain radiotherapy Receives: Radiation: Whole-brain Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression-free survival
Time from enrollment to intracranial tumor progression or death
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 2 year
CTCs level
Levels of circulating tumor cells (CTCs) in peripheral blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start29 Aug 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whole-Brain RadiotherapyStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Deng, MD, Study chair, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443397
- Sponsor's protocol ID
- NCC5213
- Status last verified
- Dec 2025
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.
- ClinicalTrials.gov ID
- NCT07443397
- Acronym / sponsor ID
- NCC5213
- Conditions
- Whole-Brain Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+WBRT | Experimental | Drug: Anlotinib, Radiation: Whole-brain RadiotherapyOral Anlotinib plus whole-brain radiotherapy |
| Control WBRT | Other | Radiation: Whole-brain RadiotherapyOnly whole-brain radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnlotinibOral 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 | Drug | Anlotinib+WBRT |
| Whole-brain RadiotherapyPrescription 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. | Radiation | Anlotinib+WBRT, Control WBRT |
Primary outcome
Intracranial progression-free survival
Time frame: 1 year
Time from enrollment to intracranial tumor progression or death
4 secondary outcomes
Intracranial objective response rate (ORR) and disease control rate (DCR)
Time frame: 1 year
Duration of intracranial response (DOR)
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 year
CTCs level
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Deng, MD study chair
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib and Whole-brain Radiotherapy in people with Whole-Brain Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Deng, MD (+86-010-87787625, dengleipumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.