NCT06969781Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- May 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06969781
What you commit to
- Study type: Interventional
- Planned participants: 120
- From May 2025 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe liver, kidney, heart, lung, or brain dysfunction or other comorbidities that preclude tolerance to MWA or targeted therapy.
- Uncontrolled conditions (including but not limited to non-pulmonary malignancies, active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, psychiatric disorders, etc.).
- Other conditions deemed by the investigator as unsuitable for study participation.
Lab values
- 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.
Other
- Chest CT findings indicating percutaneous inaccessibility of the lung lesion for MWA.
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.