Non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment Group:Oral furmonertinib mesilate tablets
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. No restriction on sex; 3. Before ablation, the primary lung tumor measures 10–30 mm in longest diameter on the lung window; 4. Before ablation, the primary lung tumor is a solid tumor with a consolidation tumor ratio (CTR) = 1; 5. The ablated primary lung tumor is confirmed as NSCLC by cytology or pathology; 6. Before ablation, tumor staging must be determined as primary or multiple primary stage IA2–IA3 lung cancer by the following imaging examinations: PET-CT, or a stepwise screening comprising brain MRI (plain or enhanced) or brain CT (plain or enhanced), chest CT (plain or enhanced), abdominal ultrasound or abdominal CT (plain or enhanced), and whole-body bone scan. Disease staging is performed according to the 9th edition of the UICC/AJCC TNM staging system for lung cancer. If PET/CT or contrast-enhanced chest CT suggests equivocal lymph node metastasis, the patient may be enrolled if one of the following is met: (1) negative pathology confirmed by biopsy via mediastinoscopy, transbronchial or esophageal ultrasound, etc.; (2) assessed as negative after multidisciplinary discussion, and a follow-up chest CT (plain or enhanced) before enrollment shows no change in the size of the suspicious lymph node compared with the chest CT before ablation; 7. Patients who are intolerant of or refuse surgery, refuse stereotactic body radiotherapy or radical radiotherapy, and have undergone CT-guided percutaneous ablation (radiofrequency, microwave, or cryoablation) within 1 month +/- 1 week, with retrospective review of intraoperative chest CT images showing an ablation margin extending 5–10 mm beyond the tumor; 8. Tumor cytology, tissue, or blood samples from the ablated lesion are confirmed by a laboratory acceptable to the investigator as harboring an EGFR sensitizing mutation (exon 19 deletion and/or L858R mutation, either alone or in combination); 9. For multiple primary stage IA2–IA3 lung cancer, in addition to meeting the Martini-Melamed criteria for multiple primary lung cancers (see Appendix B) and having non-ablated lung cancer lesions that are stable without recurrence, the following conditions must be met: (1) other confirmed lung cancer lesions are ground-glass density (CTR =5 years, and no antitumor therapy has been administered within the past 6 months; 10. If there is a prior history of extrapulmonary systemic tumor, that tumor must be stable and no systemic antitumor therapy has been given within the past 6 months; 11. A post-ablation chest CT (plain or enhanced) obtained before enrollment shows that, in the investigator's judgment, the ablation zone completely covers the pre-ablation lesion; 12. Refusal of chemotherapy, anti-angiogenic therapy, immunotherapy, and radiotherapy after ablation; 13. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 6 months; 15. Women of childbearing potential must use appropriate contraception from screening until 3 months after discontinuation of study treatment and must not breastfeed. A negative pregnancy test is required before the first dose, or one of the following criteria demonstrating no risk of pregnancy must be met: (1) Postmenopausal defined as age >50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal tre
Exclusion criteria
Exclusion criteria: 1. Pathology showing mixed small cell lung cancer (SCLC) and NSCLC; 2. Presence of EGFR exon 20 insertion and/or ALK mutation; 3. For multiple primary stage IA2–IA3 lung cancer, if the non-ablated target lesion is a solid lesion and the interval between diagnoses is =5 years but the original lung cancer is not stable; 4. Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease, left ventricular ejection fraction [LVEF] = CTCAE grade 3 despite medication]); presence of swallowing dysfunction, active gastrointestinal bleeding disease, prior major gastrectomy, or other conditions significantly affecting the absorption, distribution, metabolism, or excretion of oral drugs; 5. History of severe interstitial lung disease (ILD) (including drug-induced ILD), history of interstitial pneumonitis requiring long-term systemic steroid therapy at a dose equivalent to >10 mg/day prednisone, or any evidence of clinically active ILD; 6. Unstable angina, congestive heart failure, New York Heart Association (NYHA) class >2 chronic heart failure; 7. Myocardial infarction, coronary/peripheral artery bypass surgery, or cerebrovascular accident within 3 months; 8. Open surgical procedure (except biopsy) on any site other than the lung within 21 days before the patient receives study drug; 9. Diagnosis of another malignant disease within the past 2 years that is not stable (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ); 10. Mean QTc interval >470 ms from triplicate electrocardiograms (ECGs) (QT interval corrected using Fridericia's formula [QTcF]), or other arrhythmias or clinical conditions that may increase the risk of QT prolongation (e.g., complete left bundle branch block, third-degree atrioventricular block, PR interval >250 ms, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in first-degree relatives under 40 years of age, severe hypokalemia, etc.); 11. Inadequate bone marrow reserve or organ function, meeting any of the following laboratory values during the screening period (without corrective treatment within 1 week before blood draw): (1) Absolute neutrophil count 3 × upper limit of normal (ULN); (5) Aspartate aminotransferase >3 × ULN; (6) Total bilirubin >1.5 × ULN; (7) Creatinine >1.5 × ULN or creatinine clearance =4 weeks; 14. Currently using any drugs known to prolong the QT interval within 2 weeks before the first dose; 15. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study; 16. History of hypersensitivity to any active or inactive ingredien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS);Overall survival (OS);Disease-Free Survival Rate;Local Control Rate;Overall Survival Rate;Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Yang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed