Status:
NOT_YET_RECRUITING
MWA With or Without Furmonertinib for Early-Stage Non-Small Cell Lung Cancer
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
Shanghai Allist Pharmaceuticals Co.,Ltd.
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
NA
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 tr...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06969781
Start Date
May 1 2025
End Date
December 1 2028
Last Update
May 14 2025
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