Non-small cell lung cancer
Conditions
Interventions
Treatment group:Limertinib Combined with Radioactive Iodine-125 Seed Implantation
Sponsors
Hebei General Hospital?
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following criteria for enrollment: 1. Written informed consent obtained prior to any trial-related procedures. 2. Age >=18 years. 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). 4. Metastatic or recurrent (Stage IV) disease per the 8th edition TNM classification by the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC). 5. EGFR-sensitive mutations (Ex19del, L858R) confirmed by tumor histology/cytology or blood-based testing. 6. Oligoprogression or gradual after EGFR-TKI therapy. 7. Intolerance or refusal of surgery or external beam radiotherapy. 8. ECOG performance status of 0–2. 9. Life expectancy >=3 months. 10. At least one measurable lesion per RECIST v1.1 criteria. Lesions within prior radiotherapy fields may be considered measurable if progression is documented. 11. Adequate organ function, defined as: (a) Absolute neutrophil count (ANC) >=1.5×10?/L without granulocyte colony-stimulating factor support within 14 days; (b) Platelets >=100×10?/L without transfusion within 14 days; (c) Hemoglobin >9 g/dL without transfusion or erythropoietin use within 14 days; (d) Total bilirubin =60 mL/min (Cockcroft-Gault formula); (g) INR or PT =1 year amenorrhea), surgical sterilization, or hysterectomy. 13. Contraceptive measures with a failure rate of <1% per year for all subjects at risk of conception, during treatment and for 120 days (or 180 days per specific drug half-life) after the last dose.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Pathologically confirmed small cell lung cancer (SCLC), including mixed SCLC and NSCLC histology. 2. Extensive progression or brain metastasis after first-line EGFR-TKI therapy. 3. Contraindications to radioactive seed implantation: (a) Severe bleeding tendency: platelets =50×10?/L or severe coagulopathy (prothrombin time >18 s, prothrombin activity =1 week prior to implantation. (b) Tumor ulceration. (c) Uncontrolled diabetes mellitus. (d) Lack of suitable puncture pathway. (e) Failure to achieve prescribed dose requirements in pre-planning. 4. Prior treatments: a) Major surgery (excluding vascular access placement) within 4 weeks before the first study dose. b) Current use or inability to discontinue strong CYP3A4 inducers >=3 weeks before the first dose. c) Use of investigational agents within 5 half-lives prior to enrollment. 5. Anti-angiogenic therapy (e.g., bevacizumab, anlotinib) within 1 month before study treatment. 6. Other active malignancies, except: a) Cured non-melanoma skin cancer or carcinoma in situ. b) Solid tumors with no recurrence >5 years post-treatment (low recurrence risk per investigator assessment). 7. Residual toxicities from prior therapy >CTCAE Grade 1 (excluding alopecia or Grade 2 neuropathy from platinum-based regimens). 8. Uncontrolled comorbidities: a) Hypertension, active bleeding disorders, or infections requiring IV therapy (e.g., HBV, HCV, HIV). b) Conditions compromising safety or protocol compliance per investigator judgment. 9. Gastrointestinal disorders affecting drug absorption: Refractory nausea/vomiting, chronic GI diseases, dysphagia, or major bowel resection. 10. Cardiac dysfunction: a) QTc interval >470 ms (mean of 3 ECGs). b) ECG abnormalities: complete left bundle branch block, third-degree AV block. c) Arrhythmia risk factors: hypokalemia, congenital long QT syndrome, family history. 11. Interstitial lung disease (ILD) history, radiation pneumonitis requiring steroids, or active ILD. 12. Laboratory abnormalities: a) Bone marrow suppression: ANC 2.5×ULN; total bilirubin >1.5×ULN (>3×ULN if Gilbert’s syndrome). c) Renal impairment: Creatinine >1.5×ULN with creatinine clearance <50 mL/min. 13. Pregnancy or lactation. 14. Hypersensitivity to limertinib or structurally similar compounds. 15. Any condition that may interfere with study results, participation, or pose risks, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactHongtao Zhang
Hebei General Hospital?
Outcome results
None listed