Clinical trial · Interventional

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

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

NCT06969781CI-TRIAL-00089635not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer (NSCLC)	Malignant Lung Neoplasm	CURATED_EXACT	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
MWA	Device	—	UNRESOLVED
TKI	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
TKI-MWA-TKI
description
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.
interventionNames
1. Device: MWA
2. Drug: TKI
type
EXPERIMENTAL
label
MWA-TKI
description
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.
interventionNames
1. Device: MWA
2. Drug: TKI

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (5)

BACKGROUNDBartlett 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
BACKGROUNDHerbst 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
BACKGROUNDGu 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
BACKGROUNDNi 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
BACKGROUNDChan 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