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New treatment option for Non-Small-Cell Lung Cancer
Official title SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06476093
What this study is testing
What is Anlotinib hydrochloride?
Anlotinib hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small-cell lung cancer.
Also referred to as SRT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Age between 18-80 years, gender unspecified.
- ECOG performance status of 0 or 1; expected survival of no less than 3 months.
You likely can't join if
- Squamous cell carcinoma patients (including adenosquamous carcinoma patients) should be excluded under the following conditions: ① Cavitary lung...
- 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...
- Current presence of pulmonary pneumonia with CTCAE 5.0 grade ≥ 2.
- Individuals with various factors that affect oral medication (such as dysphagia, gastrointestinal resection, chronic diarrhea, and intestinal...
- Evidence of active bleeding, or unexplained persistent decrease in hemoglobin. Screening/enrollment should be postponed until bleeding stops and the...
See the full eligibility criteria
- 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...
- 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.
- 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:
- 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...
- Coagulation function examination: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN.
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Lianyungang, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lianyungang, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.