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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKI-MWA-TKI

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.

Group Type EXPERIMENTAL

MWA

Intervention Type DEVICE

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.

TKI

Intervention Type DRUG

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.

MWA-TKI

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.

Group Type EXPERIMENTAL

MWA

Intervention Type DEVICE

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.

TKI

Intervention Type DRUG

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.

MWA

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

Group Type ACTIVE_COMPARATOR

MWA

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No