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NCT Number: NCT06969781

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

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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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MWA

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

Drug
  • Study Drug: Furmonertinib (Shanghai Allist Pharmaceuticals Co.,Ltd.);
  • 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.

Primary outcomes

  1. 3-year disease-free survival (DFS) rate in the MWA-TKI and TKI-MWA-TKI groups

    Time frame: 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 outcomes

  1. 1-year and 2-year disease-free survival (DFS) rates in the MWA-TKI and TKI-MWA-TKI groups

    Time frame: 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.

  2. 1-year, 2-year, and 3-year overall survival (OS) rates in the MWA-TKI and TKI-MWA-TKI groups

    Time frame: 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.

  3. Overall survival (OS) in the MWA-TKI and TKI-MWA-TKI groups

    Time frame: 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.

  4. 1-year, 2-year, and 3-year disease-free survival (DFS) rates in the MWA group.

    Time frame: 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.

  5. 1-year, 2-year, and 3-year overall survival (OS) rates in the MWA group

    Time frame: 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.

  6. Overall survival (OS) in the MWA group

    Time frame: 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.

  7. The incidence of adverse events (AEs)

    Time frame: 24 months after treatment

    AEs include procedure-related adverse reactions during or after MWA and drug-related adverse reactions caused by targeted therapy.

  8. Exploration of potential predictive biomarkers and synergistic effects of MWA combined with targeted therapy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangfang Xie, MD

CONTACT

[email protected]

+13262251689

Jiayuan Sun, MD, PHD

CONTACT

[email protected]

+8618017321598

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Shanghai Allist Pharmaceuticals Co.,Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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