Non-Small-Cell Lung CancerNCT06476093
SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer
A study testing Anlotinib hydrochloride in people with Non-Small-Cell Lung Cancer and Brain Metastases, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small-Cell Lung Cancer, Brain Metastases
- What is being tested?
- Anlotinib hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 28 Feb 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in this study, sign informed consent, and demonstrate good compliance.
- Patients with histologically or pathologically confirmed EGFR wild-type and EGFR mutant non-small cell lung cancer resistant to treatment.
- The number of brain metastases is ≤ 5, and the patient has at least one assessable brain metastasis on imaging (RECIST 1.1). Additionally, the patient's physical condition allows for the completion of stereotactic radiosurgery.
- Age between 18-80 years, gender unspecified.
- ECOG performance status of 0 or 1; expected survival of no less than 3 months.
- Regardless of prior treatment, it is only required that concurrent oral administration of anlotinib during radiotherapy without intervention regarding subsequent treatment regimens.
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- Oral administration of anlotinib including, but not limited to, third-line therapy.
- Good function of major organs, with laboratory test indicators meeting the following criteria:
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- Hematological examination:
- Hemoglobin (Hb) ≥ 90g/L (no blood transfusion within 14 days);
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; total white blood cell count ≥ 3.5×10^9/L;
- Platelets (PLT) ≥ 100×10^9/L;
- Blood biochemistry examination:
- a、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastasis/bone metastasis; ≤ 5 ULN for tumor bone metastasis); b、Total bilirubin (TBIL) ≤ 1.5 × ULN; c、Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 60 ml/min;
- Coagulation function examination: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN.
Who cannot join
- Squamous cell carcinoma patients (including adenosquamous carcinoma patients) should be excluded under the following conditions:
- ① Cavitary lung cancer.
- ② Patients who have had hemoptysis within the last month before the first dose and with a maximum daily hemoptysis of ≥2.5 mL, as well as other significant clinically relevant bleeding symptoms or those with a clear bleeding tendency combined with diseases/history.
- Patients with diffuse pleural metastases, malignant pericardial effusion, or diffuse spinal cord involvement.
- Patients with a history of other malignancies within 5 years (excluding cured basal cell carcinoma of the skin, prostate intraepithelial neoplasia, and cervical intraepithelial neoplasia).
- Current presence of pulmonary pneumonia with CTCAE 5.0 grade ≥ 2.
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- Individuals with various factors that affect oral medication (such as dysphagia, gastrointestinal resection, chronic diarrhea, and intestinal obstruction).
- Evidence of active bleeding, or unexplained persistent decrease in hemoglobin. Screening/enrollment should be postponed until bleeding stops and the investigator deems it safe.
- Within the first 4 weeks before the initial dose, occurrence of any bleeding or hemorrhagic event ≥ Grade 3 according to CTCAE 5.0 standards; use of anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar agents for treatment; under the condition that prothrombin time international normalized ratio (INR) ≤ 1.5, allowing the use of low-dose warfarin for prophylactic purposes (≤ 1mg/d), low-dose heparin (≤ 12,000 U/d), or low-dose aspirin (≤ 100mg/d).
- Within the 4 weeks before the initial dose, the presence of unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis, or active bleeding from unresected tumors, or conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation; or patients who have undergone major surgeries (excluding vascular access surgery).
- Receipt of traditional Chinese medicine listed in the NMPA-approved drug instructions, which explicitly have indications for anti-tumor and lung cancer treatment (including compound Bupleurum capsules, Kangai injection, Conlear capsules/injections, Edaravone injections, Yadanzi oil injections/capsules, Xiaocanping tablets/injections, HuaChanSu capsules), or immune modulating drugs (excluding local use for pleural effusion control) within 2 weeks before the initial dose.
- History of organ or hematologic system transplantation.
- Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction.
- Patients with severe and/or uncontrolled diseases, including:
- Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥90mmHg);
- Occurrence of thrombotic events, ischemic stroke, myocardial infarction within 6 months of the first dose, congestive heart failure of Grade ≥2, or requiring treatment for arrhythmias (including QTc ≥480ms);
- Active or uncontrolled severe infections (grade ≥ 2 infection according to CTCAE 5.0), tuberculosis patients; ④ Known clinically significant liver disease history, including viral hepatitis, active HBV infection must be excluded for carriers of known hepatitis B virus (HBV) through positive HBV DNA (>2500 copies/mL or >500 IU/mL); known HCV infection and positive HCV RNA (>1×10^3 copies/mL), or other decompensated liver disease, chronic hepatitis requiring antiviral therapy; ⑤ Positive HIV test, positive rapid plasma reagin (RPR) test for syphilis; ⑥ Poorly controlled diabetes (fasting blood glucose ≥10mmol/L); ⑦ Urinalysis showing urinary protein ≥++, with confirmed 24-hour urinary protein quantification >1.0 g;
- According to the judgment of the principal investigator, patients with other factors that may lead to the forced termination of this study, such as other serious illnesses (including mental illness) requiring combined treatment, significant laboratory abnormalities, family or social factors affecting patient safety, or data and sample collection.
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
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
Xiaodong Jiang, Doctor, 18961326201, jxdysy1970@163.com
About this study
Official title: SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study
To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.
Read the detailed description
Anlotinib indication: Anlotinib is a novel oral multi-target receptor tyrosine kinase inhibitor, which has been shown to inhibit tumor growth by suppressing signaling pathways involving angiogenesis and cell proliferation. It has been approved by the Chinese National Medical Products Administration as a third-line therapy for NSCLC.
SRT indication: SRT（Stereotactic Radiation Therapy） is a form of local radiation therapy that delivers high doses of radiation in a limited number of treatments. Within Chinese guidelines and consensus, it is clearly defined that limited intracranial metastases can be treated with SRT instead of WBRT (Whole Brain Radiotherapy), achieving comparable or even superior efficacy while better preserving neurocognitive function.
- Conditions
- Non-Small-Cell Lung Cancer, Brain Metastases
- Being tested
- Anlotinib hydrochloride
- Keywords
- Anlotinib, SRT, Non-Small-Cell Lung Cancer, Brain Metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
Also called SRT
Anlotinib#12mg#PO#Q3W#d1-14# SRT#depends
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+SRT Group | Experimental | Anlotinib#12mg#PO#Q3W#d1-14# Receives: Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracerebral Progression-Free-Surviva（iPFS）
The time from the start of treatment to intracranial tumor progression or death for any reason
The time from the start of treatment to intracranial tumor progression or death for any reason
The time from the start of treatment to intracranial tumor progression or death for any reason
Measured: 20 months
intracerebral Objective Response Rate (iORR)
The proportion of patients whose intracranial tumor volume has reduced to a predetermined value and can maintain the minimum time limit
Measured: 20 months
Secondary outcomes (6)
intracerebral Progression-Free-Survival rate at 6 months and 1 year
Measured: 12 months
Progression-Free-Survival（PFS）
Measured: 20 months
Objective Response Rate（ORR）
Measured: 20 months
intracerebral Disease Control Rate（iDCR）
Measured: 20 months
Disease Control Rate（DCR）
Measured: 20 months
Overall Survival（OS）
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodong Jiang, Doc, Study chair, THE FIRST PEOPLE'S HOSPITAL OF LAINYUNGANG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476093
- Sponsor's protocol ID
- KY-20231219001-01
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06476093
- Acronym / sponsor ID
- KY-20231219001-01
- Conditions
- Non-Small-Cell Lung Cancer, Brain Metastases
- Keywords
- Anlotinib, SRT, Non-Small-Cell Lung Cancer, Brain Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.
Detailed description
Anlotinib indication: Anlotinib is a novel oral multi-target receptor tyrosine kinase inhibitor, which has been shown to inhibit tumor growth by suppressing signaling pathways involving angiogenesis and cell proliferation. It has been approved by the Chinese National Medical Products Administration as a third-line therapy for NSCLC.
SRT indication: SRT（Stereotactic Radiation Therapy） is a form of local radiation therapy that delivers high doses of radiation in a limited number of treatments. Within Chinese guidelines and consensus, it is clearly defined that limited intracranial metastases can be treated with SRT instead of WBRT (Whole Brain Radiotherapy), achieving comparable or even superior efficacy while better preserving neurocognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+SRT Group | Experimental | Drug: Anlotinib hydrochlorideAnlotinib#12mg#PO#Q3W#d1-14# |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients voluntarily participate in this study, sign informed consent, and demonstrate good compliance.
- Patients with histologically or pathologically confirmed EGFR wild-type and EGFR mutant non-small cell lung cancer resistant to treatment.
- The number of brain metastases is ≤ 5, and the patient has at least one assessable brain metastasis on imaging (RECIST 1.1). Additionally, the patient's physical condition allows for the completion of stereotactic radiosurgery.
- Age between 18-80 years, gender unspecified.
- ECOG performance status of 0 or 1; expected survival of no less than 3 months.
Key exclusion criteria (18 listed)
- ① Cavitary lung cancer.
- ② Patients who have had hemoptysis within the last month before the first dose and with a maximum daily hemoptysis of ≥2.5 mL, as well as other significant clinically relevant bleeding symptoms or those with a clear bleeding tendency combined with diseases/history.
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 |
|---|---|---|
| Anlotinib hydrochlorideAlso: SRTAnlotinib#12mg#PO#Q3W#d1-14# SRT#depends | Drug | Anlotinib+SRT Group |
Primary outcome
intracerebral Progression-Free-Surviva（iPFS）
Time frame: 20 months
The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason
intracerebral Objective Response Rate (iORR)
Time frame: 20 months
The proportion of patients whose intracranial tumor volume has reduced to a predetermined value and can maintain the minimum time limit
6 secondary outcomes
intracerebral Progression-Free-Survival rate at 6 months and 1 year
Time frame: 12 months
Progression-Free-Survival（PFS）
Time frame: 20 months
Objective Response Rate（ORR）
Time frame: 20 months
intracerebral Disease Control Rate（iDCR）
Time frame: 20 months
Disease Control Rate（DCR）
Time frame: 20 months
Overall Survival（OS）
Time frame: 20 months
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 26 Jun 2024.
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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.
Xiaodong Jiang, Doc study chair
THE FIRST PEOPLE'S HOSPITAL OF LAINYUNGANG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anlotinib hydrochloride in people with Non-Small-Cell Lung Cancer and Brain Metastases, run by The First People's Hospital of Lianyungang 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 16 inclusion and 18 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 26 Jun 2024. 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.
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 Xiaodong Jiang, Doc (86-0518-85469074, jxdysy1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracerebral Progression-Free-Surviva（iPFS） (time frame: 20 months). The study lists 2 primary outcomes in all. 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 26 Jun 2024.