RecruitingPhase 2NCT07323056

Neoadjuvant Sacituzumab Tirumotecan and Limertinib for Potentially Resectable Stage Ⅲ EGFR-mutant Non-small Cell Lung Cancer

Sacituzumab Tirumotecan and Limertinib for Conversion Therapy in Locally Advanced Potentially Resectable EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Single-arm, Exploratory Clinical Study


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

36 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — sacituzumab tirumotecan (an antibody-drug conjugate that targets cancer cells) and limertinib (an EGFR-targeted drug) — given before surgery in patients with stage III non-small cell lung cancer (NSCLC) that has a specific mutation in a gene called EGFR. The goal is to shrink the tumor enough to allow surgery. **You may be eligible if...** - You have non-small cell lung cancer confirmed to have an EGFR mutation - Your cancer is locally advanced (stage IIIA, IIIB, or IIIC) and not yet suitable for immediate surgery - You have not received any prior cancer treatment - You are in good health (ECOG score 0–1) and your lungs can handle surgery - You are 18 or older **You may NOT be eligible if...** - You have had prior EGFR-targeted therapy or any TROP2 antibody-drug conjugate treatment - You are allergic to either study drug - You have a history of another primary cancer or organ transplant - You have active autoimmune disease or are on immunosuppressive steroids - You had major surgery in the 4 weeks before starting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Tirumotecan and Limertinib

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.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, China

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NCT07323056