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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Lung Cancer (NSCLC)

Treatments: Drug: TKI; Device: MWA

Study type: Interventional

Funder types: Other

Identifiers

NCT06969781

IS25074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

TKI-MWA-TKI

Experimental group

Description:

In the Furmonertinib induction followed by microwave ablation (TKI-MWA-TKI) group, patients first undergo a 3-month induction therapy with the targeted agent. After completion of induction therapy, CT re-examination is performed to assess changes in the lesion. If no contraindications are present, microwave ablation (MWA) is conducted. Post-procedure, in the absence of significant complications, targeted therapy is resumed and continued for up to 21 months, provided no severe toxicities occur.

Treatment:

Device: MWA

Drug: TKI

MWA-TKI

Experimental group

Description:

In the microwave ablation combined with Furmonertinib (MWA-TKI) group, microwave ablation (MWA) is initially performed on the lesion. In the absence of significant postoperative complications, targeted therapy is initiated and continued for up to 24 months, provided no severe toxicities occur.

Treatment:

Device: MWA

Drug: TKI

MWA

Active Comparator group

Description:

In the MWA group, only microwave ablation (MWA) is performed on the lesion without administration of Furmonertinib.

Treatment:

Device: MWA