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

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 Overview

• Status: Recruiting
• Conditions: EGFR-mutant Non-small Cell Lung Cancer; Potentially Resectable
• Intervention / Treatment: Drug: Sacituzumab Tirumotecan and Limertinib

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peng Zhang, PhD; Phone Number: 021-65115006; Email: zhangpeng1121@tongji.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Pulmonary Hospital
    • Contact: Peng Zhang, PhD; Phone Number: 021-65115006; Email: zhangpeng1121@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surgical treatment after targeted therapy combined with chemotherapy

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response (pCR) rate	Perioperative

Secondary Outcome Measures

Outcome Measure	Time Frame
R0 resection rate	Perioperative
Event-free suvival (EFS)	Up to 60 months
Overall suvival (OS)	Up to 60 months
Major pathologic response (MPR) rate	Perioperative
Objective response rate (ORR)	Up to 3 months
Incidence of treatment discontinuation due to AE/SAE	Up to 3 months
Treatment-related adverse event (TRAE)	Up to 3 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; EGFR-mutant; Limertinib; Sacituzumab Tirumotecan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LungMate-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The researchers will consider whether IPD is available to other researchers only after the paper is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No