EGFR-mutant stage IA non-small cell lung cancer after non-radical treatment
Conditions
Interventions
Non-radical surgical resection group:Furmonertinib
SBRT/RF ablation group:Furmonertinib
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. subjects participate voluntarily and sign a written informed consent form; 2. subjects were =18 years of age, male or female; 3. A single lesion, or multiple primary lesions, with the primary lesion being a pure solid nodule of 3 cm or less that does not contain ground-glass on imaging; if there is a secondary lesion, the secondary lesion is a ground-glass-containing nodule with a solid component smaller than that of the primary lesion; 4. Pre-treatment systemic assessment of clinical TNM stage IA (AJCC 9th edition) (PET-CT is recommended to exclude lymph nodes and distant metastases); 5. Patients who are unable to tolerate radical surgical resection due to their functional status, or who are unable to tolerate surgery, or who refuse to undergo radical surgical treatment; 6. Non-radical surgery group: the primary lesion undergoes wedge resection or lung segmental resection without systematic lymph node dissection, in which the lung segmental resection is performed on a pure solid nodule with an imaging lesion diameter of 2-3 cm; if there is a secondary lesion, it can be treated with surgery at the same time or at an elective stage, or with observation and waiting; 7. SBRT/ablation group: the primary lesion receives SBRT or receives percutaneous/transbronchoscopic ablation; if there is a secondary lesion, it can be treated with SBRT/ablation at the same time or on an elective basis, or watch and wait; 8. be confirmed as having an EGFR exon 19 deletion mutation (19del) or exon 21L858R point mutation (L858R) by central laboratory testing of a histological or cytological specimen, or, in the absence of a histological or cytological specimen, receive a peripheral blood test for the presence of an EGFR 19del or an EGFR 21L858R, which may be present singly or in combination; 9. subjects who have undergone non-radical surgical resection, have fully recovered from surgery (including complete postoperative wound healing), and have commenced study treatment 3-4 weeks postoperatively; 10. subjects who have undergone radical SBRT/ablation, have recovered from SBRT/ablation, have a previous CTCAE grade = 1, and begin study treatment 7-14 days after completion of treatment; 11. have an ECOG physical condition score of 0-1; 12. subjects with a life expectancy of = 12 weeks at the investigator's discretion; 13. premenopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose;
Exclusion criteria
Exclusion criteria: Patients with any of the following are not eligible for enrolment in this study: 1. subjects with surgical R1/R2 resection; 2. any antitumour therapy (including chemotherapy, radiotherapy, immunotherapy and EGFR-TKI) within the previous five years; 3. anticipate the need to receive other anti-tumour therapy other than this study during the trial period; 4. who have had or plan to have major surgery during the trial within 4 weeks prior to the first dose; 5. who have required prolonged use of a strong inhibitor or strong inducer of CYP3A4 within 7 days prior to the first dose or are expected to require it during the trial period; 6. require the use of Chinese medicines or Chinese herbal preparations with anti-tumour indications, Chinese medicines and Chinese herbal preparations with adjuvant therapeutic effects on tumours within 2 weeks prior to the first dose or during the anticipated trial period; 7. Patients who are receiving medications known to prolong the QTc interval or may cause tip-twist ventricular tachycardia and who need to continue to receive these medications during the study period; 8. severe gastrointestinal abnormalities, diseases or clinical states that may interfere with the uptake, transit, or absorption of the study drug; 9. other malignant tumours or history of other malignant tumours within 5 years; except for basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid gland, and tumours of the superficial bladder, which have been effectively controlled 10. Previous interstitial lung disease (ILD), drug-induced interstitial lung disease; or those with clinical manifestations such as suspected interstitial lung disease or high risk factors; 11. deficiencies in bone marrow reserve, liver, kidney organs, etc., meeting the following laboratory criteria: Absolute neutrophil count 2.5 x upper limit of normal (ULN) Aspartate transaminase (AST) >2.5 x ULN Total bilirubin >1.5 x ULN or >3 x ULN with Gilbert's syndrome (unconjugated hyperbilirubinaemia) Creatinine clearance 470 msec on ECG at rest Serious abnormalities in rhythm, cardiac conduction, and resting ECG morphology, e.g., complete left bundle branch block, degree III heart block, degree II heart block, PR interval >250 msec, etc. Any factor that may increase the risk of QTc interval prolongation or the risk of arrhythmic events, e.g., cardiac failure, hypokalaemia, hypomagnesaemia, hypocalcaemia, etc., congenital long QT interval syndrome, family history of long QT interval syndrome, sudden unexplained death in a first-degree relative under the age of 40 years, or any known prolongation of the QTc interval that results in tip-twist type Tachycardia in combination 13. being pregnant or breastfeeding; 14. any other condition that, in the opinion of the investigator, makes participation in this study inappropriate;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year PFS rate in the non-radical surgical resection group; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year PFS rate in the non-radical surgical resection group;5-year PFS rate in the non-radical surgical resection group;3-year OS rate in the non-radical surgical resection group;Safety outcomes;5-year OS rate in the non-radical surgical resection group;1-year OS rate in the non-radical surgical resection group;1-year PFS rate in the SBRT/ablation group;3-year PFS rate in the SBRT/ablation group;5-year PFS rate in the SBRT/ablation group;1-year OS rate in the SBRT/ablation group;3-year OS rate in the SBRT/ablation group;5-year OS rate in the SBRT/ablation group;Non-Radical Surgical Resection Versus SBRT/Ablation Treatment Outcomes for Stage IA NSCLC Patients;Efficacy response of furmonertinib in multiple primary patients with other untreated lesions; | — |
Countries
China
Contacts
Public ContactWentao Fang
Department of thoracic surgery, Shanghai Chest Hospital
Outcome results
None listed