AzTrials
AzTrials

Lung Cancer (NSCLC)NCT06969781

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

A study testing MWA and TKI in people with Lung Cancer (NSCLC), run by Shanghai Chest Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
MWA and TKI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
May 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fangfang Xie, MD contact

+13262251689

xiefang314@126.com

Jiayuan Sun, MD, PHD contact

+8618017321598

jysun1976@163.com

About this study

Official title: Exploratory Clinical Study on Microwave Ablation 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.

Read the 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.

Being tested
MWA, TKI
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MWADevice

    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.

  • TKIDrug

    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.
Study groups in NCT06969781
Study groupRoleWhat they receive
TKI-MWA-TKIExperimentalIn 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.
Receives: Device: MWA; Drug: TKI
MWA-TKIExperimentalIn 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.
Receives: Device: MWA; Drug: TKI
MWAActive comparatorIn the MWA group, only microwave ablation (MWA) is performed on the lesion without administration of Furmonertinib.
Receives: Device: MWA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The proportion of subjects who remain free from disease recurrence or death from the start of treatment until 3 years post-treatment.

    Measured: From the time of treatment to the time of disease progression or death, assessed up to 3 year

Secondary outcomes (8)
  1. 1-year and 2-year disease-free survival (DFS) rates in the MWA-TKI and TKI-MWA-TKI groups

    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.

    Measured: From the time of treatment to the time of disease progression or death, assessed up to 1 year or 2 year

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

    The proportion of subjects who remain alive from the start of treatment until 1 year, 2 years, and 3 years post-treatment.

    Measured: From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year.

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

    The time from the start of treatment to the subject's death or the last follow-up.

    Measured: From the time of treatment to the time of death, assessed up to 5 year.

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

    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.

    Measured: From the time of treatment to the time of disease progression or death, assessed up to 1 year, 2 year or 3 year.

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

    The proportion of subjects who remain alive from the start of treatment until 1 year, 2 years, and 3 years post-treatment.

    Measured: From the time of treatment to the time of death, assessed up to 1 year, 2 year and 3 year.

  6. Overall survival (OS) in the MWA group

    The time from the start of treatment to the subject's death or the last follow-up.

    Measured: From the time of treatment to the time of death, assessed up to 5 year.

  7. The incidence of adverse events (AEs)

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

    Measured: 24 months after treatment

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

    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.

    Measured: Disease progression or up to 2 years (whichever occurs first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969781
Sponsor's protocol ID
IS25074
Status last verified
May 2025
First submitted
29 Apr 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bartlett EC, Rahman S, Ridge CA. Percutaneous image-guided thermal ablation of lung cancer: What is the evidence? Lung Cancer. 2023 Feb;176:14-23. doi: 10.1016/j.lungcan.2022.12.010. Epub 2022 Dec 22.

    PubMed 36571982
  • Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. doi: 10.1200/JCO.22.02186. Epub 2023 Jan 31.

    PubMed 36720083
  • Gu XY, Jiang Z, Fang W. Cryoablation combined with molecular target therapy improves the curative effect in patients with advanced non-small cell lung cancer. J Int Med Res. 2011;39(5):1736-43. doi: 10.1177/147323001103900516.

    PubMed 22117974
  • Ni Y, Bi J, Ye X, Fan W, Yu G, Yang X, Huang G, Li W, Wang J, Han X, Ni X, Wei Z, Han M, Zheng A, Meng M, Xue G, Zhang L, Wan C. Local microwave ablation with continued EGFR tyrosine kinase inhibitor as a treatment strategy in advanced non-small cell lung cancers that developed extra-central nervous system oligoprogressive disease during EGFR tyrosine kinase inhibitor treatment: A pilot study. Medicine (Baltimore). 2016 Jun;95(25):e3998. doi: 10.1097/MD.0000000000003998.

    PubMed 27336903
  • 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.

    PubMed 33449192

Questions about this trial

What is this clinical trial studying?

A study testing MWA and TKI in people with Lung Cancer (NSCLC), run by Shanghai Chest Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fangfang Xie, MD (+13262251689, xiefang314@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06969781, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in