mwa with or without furmonertinib for early-stage non-small cell lung cancer

Conditions: Lung Cancer (NSCLC)

Summary: this is a single-center randomized trial that investigates microwave ablation (mwa) combined with egfr-tki therapy in 120 early-stage nsclc patients (t1-t2n0m0, egfr-mutant) unsuitable for standard treatments. participants are stratified by tumor characteristics and randomized equally to mwa alone, mwa-tki concurrent, or tki induction followed by mwa-tki, assessing disease-free survival, overall survival, and safety outcomes. the study compares the clinical benefits and optimal sequencing of local ablation with targeted therapy in early-stage egfr-mutant nsclc management.

this is a single-center, randomized, controlled, exploratory study enrolling patients with mixed ground-glass or solid lesions on ct, histologically or cytologically confirmed as nsclc, harboring egfr mutations, and clinically staged as ia, ib, or iia (size ≤5 cm, t1-t2n0m0). patients deemed unsuitable for or refusing surgery/radiotherapy after multidisciplinary assessment were included. eligible participants who provided informed consent were randomized in a 1:1:1 ratio into three groups: microwave ablation alone (mwa), mwa combined with targeted therapy (mwa-tki), or targeted therapy induction followed by mwa combined with targeted therapy (tki-mwa-tki). randomization was stratified by solid tumor proportion (\ 30 mm), and egfr mutation status (ex19del vs ex21 l858r). the study aims to enroll 120 participants. the primary endpoints include disease-free survival (dfs), overall survival (os), and the incidence of adverse events. the study evaluates the efficacy, safety, and clinical benefits of mwa combined with egfr-tki therapy in early-stage nsclc, comparing different treatment sequences.

Eligibility criteria:
inclusion criteria: * ct findings showing mixed ground-glass or solid lesions, histologically or cytologically confirmed as nsclc, with clinical stages ia, ib, or iia (size ≤5 cm, t1-t2n0m0) according to the 9th edition of tnm classification. * egfr exon 19 deletion or exon 21 l858r mutation. * age ≥18 years. * ecog ps score of 0-2. * expected survival ≥3 months. * deemed unsuitable for or refusal of surgery/radiotherapy after multidisciplinary discussion. * no prior egfr-tki targeted therapy. * willing to undergo initial ablation therapy, with good compliance to examinations and follow-ups, and able to understand the study and provide informed consent. exclusion criteria: * severe liver, kidney, heart, lung, or brain dysfunction or other comorbidities that preclude tolerance to mwa or targeted therapy. * chest ct findings indicating percutaneous inaccessibility of the lung lesion for mwa. * platelet count \<50×10⁹/l, severe bleeding tendency, or uncorrectable coagulation disorders. * current or prior (within 3 months) use of anti-tumor drugs or egfr-tki therapy. * uncontrolled conditions (including but not limited to non-pulmonary malignancies, active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, psychiatric disorders, etc.). * pregnant or breastfeeding women, or those planning pregnancy during the study. * other conditions deemed by the investigator as unsuitable for study participation.