About this trial
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?
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- furmonertinib
- ablation
- stereotactic body radiotherapy