NCT06969781

MWA With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer

Exploratory Clinical Study on Microwave Ablation With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 (\<50% vs ≥50%), tumor size (8-30 mm vs \>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.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DEVICE	MWA	Enrolled participants undergo microwave ablation (MWA) after comprehensive assessment of lesion location, size, and individual condition. CT or other imaging modalities are used to monitor changes in the ablation zone. The puncture needle is appropriately distributed within the lesion based on its morphology, and ablation duration is determined by imaging-confirmed coverage of the lesion. All procedures are performed under general anesthesia. Ablation time, power, and cycles are recorded intraoperatively, with continuous ECG monitoring throughout. Immediate post-procedure chest CT or other imaging is performed to document intraoperative complications (e.g., pneumothorax, bleeding). Participants are routinely observed for 24 hours post-procedure, followed by CT re-examination and documentation of any complications.
DRUG	TKI	1. Study Drug: Furmonertinib (Shanghai Allist Pharmaceuticals Co.,Ltd.); 2. Administration: Oral, 80 mg once daily. In the MWA-TKI group, targeted therapy is initiated post-MWA if no significant complications occur, continuing for up to 24 months without severe toxicity. In the TKI-MWA-TKI group, a 3-month induction with Furmonertinib is followed by CT re-evaluation; if no contraindications are present, MWA is performed, and targeted therapy resumes post-procedure, continuing for up to 21 months without severe toxicity.

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-05-14
• Last updated: 2025-05-14