MWA With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer (NSCLC)
- Interventions
- Device: MWADrug: TKI
- Registration Number
- NCT06969781
- Lead Sponsor
- Shanghai Chest Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TKI-MWA-TKI MWA 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. TKI-MWA-TKI 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. MWA-TKI MWA 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. MWA-TKI 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. MWA MWA In the MWA group, only microwave ablation (MWA) is performed on the lesion without administration of Furmonertinib.
- Primary Outcome Measures
Name Time Method 3-year disease-free survival (DFS) rate in the MWA-TKI and TKI-MWA-TKI groups From the time of treatment to the time of disease progression or death, assessed up to 3 year The proportion of subjects who remain free from disease recurrence or death from the start of treatment until 3 years post-treatment.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) in the MWA-TKI and TKI-MWA-TKI groups From the time of treatment to the time of death, assessed up to 5 year. The time from the start of treatment to the subject's death or the last follow-up.
1-year, 2-year, and 3-year overall survival (OS) rates in the MWA-TKI and TKI-MWA-TKI groups From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year. The proportion of subjects who remain alive from the start of treatment until 1 year, 2 years, and 3 years post-treatment.
Exploration of potential predictive biomarkers and synergistic effects of MWA combined with targeted therapy Disease progression or up to 2 years (whichever occurs first) By comparing pre- and post-treatment tumor biopsy specimens, peripheral blood samples, and bronchoalveolar lavage fluid samples, this study investigates changes in local lesions and the systemic microenvironment, including biomarkers, metabolites, and the immune microenvironment, and their relationship with efficacy and prognosis. Additionally, potential regulatory pathways are explored. Furthermore, by comparing the three groups, the study examines whether MWA combined with targeted therapy can produce synergistic effects, whether these effects are related to the timing of targeted therapy, and the underlying regulatory mechanisms of such synergy.
1-year and 2-year disease-free survival (DFS) rates in the MWA-TKI and TKI-MWA-TKI groups From the time of treatment to the time of disease progression or death, assessed up to 1 year or 2 year The proportion of subjects who remain free from disease recurrence or death from the start of treatment until 1year post-treatment or 2 years post-treatment.
1-year, 2-year, and 3-year disease-free survival (DFS) rates in the MWA group. From the time of treatment to the time of disease progression or death, assessed up to 1 year, 2 year or 3 year. The proportion of subjects who remain free from disease recurrence or death from the start of treatment until 1 year, 2 years, and 3 years post-treatment.
1-year, 2-year, and 3-year overall survival (OS) rates in the MWA group From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year. The proportion of subjects who remain alive from the start of treatment until 1 year, 2 years, and 3 years post-treatment.
Overall survival (OS) in the MWA group From the time of treatment to the time of death, assessed up to 5 year. The time from the start of treatment to the subject's death or the last follow-up.
The incidence of adverse events (AEs) 24 months after treatment AEs include procedure-related adverse reactions during or after MWA and drug-related adverse reactions caused by targeted therapy.