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?

Inclusion Criteria:

• 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
• ECOG performance status score of 0-2
• Deemed medically inoperable or refuse surgery after multidisciplinary evaluation
• Pulmonary lesions suitable for ablation or radiotherapy (either modality)
• Adequate major organ function

Exclusion Criteria:

• 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
• Patients with hepatitis B (hepatitis B surface antigen [HBsAg] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV-RNA indicating viral replication)
• Receipt of curative-intent radiotherapy within 3 months prior to the first dose
• Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered)
• Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study