NSCLC
Conditions
Interventions
Experimental group:Anlotinib: 12 mg, po, qd, d1-14, every 3 weeks as one treatment cycle
dose adjustment is allowed for patients with intolerable toxicity.
Fractionated Stereotactic Radiotherapy (FSRT): at a dose of 40 Gy in 10 fractions or 30 Gy in 5 fractions.
Sponsors
General Hospital of Pingmei Shenma Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, sign the informed consent form, and have good compliance; 2. Age >= 18 years at the time of signing the informed consent form, regardless of gender; 3. Diagnosed with advanced or metastatic NSCLC, with disease progression after previous first-line standard therapy; 4. Meet at least one of the following imaging criteria on contrast-enhanced brain magnetic resonance imaging (MRI): (1) >=3 measurable intracranial lesions, with at least one lesion having a maximum diameter >=1 cm; or (2) 1-2 measurable intracranial lesions, with at least one lesion having a maximum diameter >=1 cm; or (3) total intracranial tumor volume >=15 cm^3; or (4) lesion located within 5 mm of the brainstem; and extrcranial disease status is stable at enrollment; 5. Complete blood count (within 14 days, without blood transfusion or use of hematopoietic growth factor drugs for correction): Hemoglobin (Hb) >=90 g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet (PLT) >=80×10^9/L; 6. Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 mL/min; 7. Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%; 9. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 10. Investigator determines that the subject has sufficient organ function; 11. Patients positive for driver genes such as EGFR/ALK/ROS1 or patients negative for driver genes who have progressed after first-line standard treatment can be enrolled; 12. Subjects with reproductive potential must use appropriate contraception during the study and for 120 days after the study ends, have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Patients with small cell lung cancer are excluded; 2. Patients with imaging evidence of tumor invasion into major blood vessels; or those judged by the investigator to be at high risk of tumor invasion into major blood vessels leading to fatal massive hemorrhage during the study; or patients with obvious cavitary or necrotic pulmonary tumors; 3. History of allergy to any component of Anlotinib; 4. Patients with any severe and/or uncontrolled diseases, including: (1) Patients with poorly controlled blood pressure (systolic BP >=150 mmHg, diastolic BP >=100 mmHg); (2) Patients with grade I or higher myocardial ischemia, myocardial infarction, arrhythmias (including QTc >=480ms), and grade >=2 congestive heart failure (NYHA classification); (3) Patients with coagulation disorders (INR >1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT >1.5 ULN), bleeding tendencies, or receiving thrombolytic or anticoagulant therapy; (4) Patients with active or uncontrolled severe infections; (5) Patients with cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment; (6) Patients with renal failure requiring hemodialysis or peritoneal dialysis; (7) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; (8) Patients with poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); (9) Patients with abnormal urinalysis showing proteinuria >=, and confirmed 24-hour urine protein quantification >1.0g; (10) Patients who experienced clinically significant hemoptysis within 2 weeks before enrollment (daily hemoptysis >50 ml); or with clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood >=, or with vasculitis, etc.; (11) Patients who experienced clinically significant hemoptysis within 2 weeks before enrollment (daily hemoptysis >50 ml); or with clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood >=, or with vasculitis, etc. 5. History of arterial/venous thromboembolic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism; 6. Subjects who have undergone major surgery or sustained severe trauma, with less than 14 days elapsed since the resolution of surgical or traumatic effects prior to enrollment; 7. Patients currently participating in another clinical study, or less than 4 weeks since the end of treatment in the previous clinical trial; 8. Pregnant or lactating women; 9. Confirmed past medical history of neurological or psychiatric disorders; 10. Patients judged by the investigator to have other factors that may lead to premature termination of the study, such as other severe illnesses, significant laboratory abnormalities, or family and social factors that may affect subject safety, as well as trial data and sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Adverse Events (AE);Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free Survival (PFS);Duration of Response (DoR);Overall Survival (OS);Quality of life score; | — |
Countries
China
Contacts
Public ContactChen Xiaoliang
General Hospital of Pingmei Shenma Group
Outcome results
None listed