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

NCT ID: NCT07323056

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-01

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.

Conditions

EGFR-mutant Non-small Cell Lung Cancer; Potentially Resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical treatment after targeted therapy combined with chemotherapy

Group Type: EXPERIMENTAL

Sacituzumab Tirumotecan and Limertinib

Intervention Type: DRUG

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.

Interventions

Sacituzumab 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.

Intervention Type: DRUG

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, AIDS or HIV carriers
• Patients with active or previously had and may recur autoimmune diseases
• Currently receiving systemic hormone therapy (such as equivalent to more than 10 mg of prednisone per day or any other form of immunosuppressive therapy within 14 days before the first dose)
• Patients who have received any EGFR-TKI or TROP2 ADC treatment before

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Peng Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Zhang, PhD

Role: CONTACT

zhangpeng1121@tongji.edu.cn

021-65115006

Facility Contacts

Peng Zhang, PhD

Role: primary

zhangpeng1121@tongji.edu.cn

021-65115006

Other Identifiers

LungMate-037

Identifier Type: -

Identifier Source: org_study_id