The goal of this Single-arm, Phase II clinical trial is to learn whether ablation or stereotactic radiotherapy combined with furmonertinib can treat early-stage non-small cell lung cancer in patients who are inoperable or refuse surgery.
The main purposes of this study is to answer:
Can ablation or stereotactic radiotherapy combined with furmonertinib improve survival in patients with early-stage NSCLC who are inoperable or refuse surgery? Can ablation or stereotactic radiotherapy combined with furmonertinib reduce recurrence in patients with early-stage NSCLC who are inoperable or refuse surgery?
Voluntarily participate in the clinical study
Aged ≥ 18 years at the time of signing the informed consent form
Histologically or cytologically confirmed early-stage T1-3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence
Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations
Known severe allergic reaction (NCI-CTCAE v5.0 grade ≥ 3) to any monoclonal antibody or any excipient of the study drug
Known contraindications to ablation or radiotherapy
Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan
Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose
Single group
furmonertinib
Drugfurmonertinib 80 mg once daily (QD), administered orally for 3 consecutive years
ablation
Procedure/Surgery1. Immobilization and image guidance: Supine or prone position; vacuum cushion or mask to limit motion. CT guidance for entry point, angle, and depth; ultrasound for selected peripheral lesions. 2. Ablation target planning: Ablation zone should cover GTV with ≥5-10 mm margin. For tumors near critical structures, pursue adequate margin when safe; consider heat sink or thermal isolation. 3. Ablation procedure: Choose MWA, RFA, or cryoablation based on tumor size, location, anatomy, and resources. 4. Intraprocedural monitoring and endpoint assessment: CT during/after ablation to confirm ground-glass opacity covers tumor with planned margin. Ablation zone ≥5 mm beyond tumor = technical success. If inadequate, reposition and supplement. 5. Post-procedure management and follow-up: Monitor vital signs; manage complications as needed.
stereotactic body radiotherapy
Radiation1. Immobilization: Use a thermoplastic mask or vacuum cushion for immobilization based on the treatment site. 2. CT simulation: After immobilization and stabilization of breathing, laser alignment is performed, followed by 4D-CT simulation (preferred) or conventional CT simulation. 3. Radiotherapy target delineation and dose: GTV includes the primary lung tumor and metastatic lymph nodes after chemotherapy. A 5-mm margin is added to form the PTV. 4. Radiotherapy plan: For peripheral lesions: 48 Gy in 4 fractions or 50 Gy in 5 fractions; for central lesions: 60 Gy in 8 fractions or 60 Gy in 10 fractions.
2-year EFS rate
defined as the proportion of patients who experience no event (including disease progression, recurrence, distant metastasis, discontinuation of treatment for any reason, or death) within 24 months from the start of treatment, relative to the total enrolled population.
3-year EFS rate
defined as the proportion of patients who experience no event (including disease progression, recurrence, distant metastasis, or death) within 36 months from the start of treatment, relative to the total enrolled population.
overall survival
defined as the time from the start of treatment to death from any cause
Local control rate (LCR)
defined as the proportion of patients who show no radiographic enlargement or recurrence of the primary tumor during follow-up
Time to distant metastasis
defined as the time from the start of treatment to the first occurrence of distant metastasis (e.g., to bone, brain, liver, or distant lymph nodes)
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This trial is not recruiting at the moment. You can still explore other options:
