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

NCT06969781 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-14

No results posted yet for this study

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)

Interventions

DEVICE

MWA

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.

DRUG

TKI

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.

Sponsors & Collaborators

  • Shanghai Allist Pharmaceuticals Co.,Ltd.

    collaborator UNKNOWN

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Jiayuan Sun, MD, PHD · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969781 on ClinicalTrials.gov