This study is a prospective, single-arm, exploratory clinical research aimed at evaluating the efficacy and safety of lucetamab in combination with leucovorin in the conversion therapy of locally advanced potentially resectable EGFR mutation-positive non-small cell lung cancer, providing more robust clinical evidence for the improvement of treatment modalities for EGFR-mutated locally advanced NSCLC. At the same time, it seeks to identify biomarkers that can predict the therapeutic effect of the combination of lucetamab and leucovorin, offering more precise guidance for the selection of clinical treatment plans and enabling patients to receive the optimal treatment regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Sacituzumab Tirumotecan injection is administered once every two weeks for a total of six treatments. Sacituzumab Tirumotecan injection: 4 mg/kg, intravenous infusion, Q2W. Limertinib is administered for 12 weeks. Limertinib: standard dose, oral, Qd. After the completion of the neoadjuvant treatment cycle, enhanced chest CT and other evaluations are conducted. The feasibility of radical surgery is assessed by MDT. Patients who are eligible for surgery will undergo surgical treatment, and the treatment plan for those who are not eligible for surgery will be determined after discussion by MDT.
Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGPathological complete response (pCR) rate
Time frame: Perioperative
Major pathologic response (MPR) rate
Time frame: Perioperative
Objective response rate (ORR)
Time frame: Up to 3 months
Event-free suvival (EFS)
Time frame: Up to 60 months
Overall suvival (OS)
Time frame: Up to 60 months
R0 resection rate
Time frame: Perioperative
Incidence of treatment discontinuation due to AE/SAE
Time frame: Up to 3 months
Treatment-related adverse event (TRAE)
Time frame: Up to 3 months
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