Clinical trial NCT06969781: MWA With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer
Official title: Exploratory Clinical Study on Microwave Ablation With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer (NSCLC)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Allist Pharmaceuticals Co.,Ltd.
First posted: 2025-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 3-year disease-free survival (DFS) rate in the MWA-TKI and TKI-MWA-TKI groups
timeFrame: From the time of treatment to the time of disease progression or death, assessed up to 3 year
Secondary outcomes:
measure: 1-year and 2-year disease-free survival (DFS) rates in the MWA-TKI and TKI-MWA-TKI groups
timeFrame: From the time of treatment to the time of disease progression or death, assessed up to 1 year or 2 year
measure: 1-year, 2-year, and 3-year overall survival (OS) rates in the MWA-TKI and TKI-MWA-TKI groups
timeFrame: From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year.
measure: Overall survival (OS) in the MWA-TKI and TKI-MWA-TKI groups
timeFrame: From the time of treatment to the time of death, assessed up to 5 year.
measure: 1-year, 2-year, and 3-year disease-free survival (DFS) rates in the MWA group.
timeFrame: From the time of treatment to the time of disease progression or death, assessed up to 1 year, 2 year or 3 year.
measure: 1-year, 2-year, and 3-year overall survival (OS) rates in the MWA group
timeFrame: From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year.
measure: Overall survival (OS) in the MWA group
timeFrame: From the time of treatment to the time of death, assessed up to 5 year.
measure: The incidence of adverse events (AEs)
timeFrame: 24 months after treatment
measure: Exploration of potential predictive biomarkers and synergistic effects of MWA combined with targeted therapy
timeFrame: Disease progression or up to 2 years (whichever occurs first)
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chan MV, Huo YR, Cao C, Ridley L. Survival outcomes for surgical resection versus CT-guided percutaneous ablation for stage I non-small cell lung cancer (NSCLC): a systematic review and meta-analysis. Eur Radiol. 2021 Jul;31(7):5421-5433. doi: 10.1007/s00330-020-07634-7. Epub 2021 Jan 15.