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Recruiting Phase 2 NCT07323056

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

Trial Parameters

Condition EGFR-mutant Non-small Cell Lung Cancer
Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-01
Completion 2026-06-01
Interventions
Sacituzumab Tirumotecan and Limertinib

Brief 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 Criteria

Inclusion Criteria: * Sign the informed consent form * The age of the subjects is over 18 years old * Patients with non-small cell lung cancer (NSCLC) with EGFR mutation confirmed by pathology * Confirmed as locally advanced NSCLC (IIIA, IIIB, IIIC) by chest CT, PET-CT or/and EBUS, and MDT discussion concludes that immediate local surgery is not suitable * Have not received systematic anti-tumor treatment before * The researcher confirms at least one measurable lesion according to RECIST 1.1 criteria * Good lung function and able to tolerate surgical treatment * ECOG score is 0 to 1 Exclusion Criteria: * Allergy to Sacituzumab Tirumotecan or any of its excipients * Patients allergic to Limertinib or any of its excipients * Patients with a history of other primary tumors; patients with a history of allogeneic organ transplantation * Major surgery within 4 weeks before the first dose (excluding diagnostic biopsy) * Patients with drug addiction such as drug abuse, long-term alcohol abuse,

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