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

NCT06969781 | Not Yet Recruiting

• 1 other identifier: IS25074
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• 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

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

TKI-MWA-TKI

EXPERIMENTAL

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.

Device: MWA; Drug: TKI

MWA-TKI

EXPERIMENTAL

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.

Device: MWA; Drug: TKI

MWA

ACTIVE COMPARATOR

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

Device: MWA

Interventions

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.

MWA; MWA-TKI; TKI-MWA-TKI

TKI 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; TKI-MWA-TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Shanghai Allist Pharmaceuticals Co.,Ltd.: collaborator

Related Publications (5)

• 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.

  PMID: 36571982 BACKGROUND

• 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.

  PMID: 36720083 BACKGROUND

• 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.

  PMID: 22117974 BACKGROUND

• 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.

  PMID: 27336903 BACKGROUND

• 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.

  PMID: 33449192 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Jiayuan Sun, MD, PHD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangfang Xie, MD

CONTACT

+13262251689; xiefang314@126.com

Jiayuan Sun, MD, PHD

CONTACT

+8618017321598; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share