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

NCT07323056 | Recruiting Phase 2

• 1 other identifier: LungMate-037
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

non-small cell lung cancer; EGFR-mutant; Sacituzumab Tirumotecan; Limertinib

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Perioperative

Secondary Outcomes (7)

• Major pathologic response (MPR) rate

  Perioperative

• Objective response rate (ORR)

  Up to 3 months

• Event-free suvival (EFS)

  Up to 60 months

• Overall suvival (OS)

  Up to 60 months

• R0 resection rate

  Perioperative

Study Arms (1)

Surgical treatment after targeted therapy combined with chemotherapy

EXPERIMENTAL

Drug: Sacituzumab Tirumotecan and Limertinib

Interventions

Sacituzumab Tirumotecan and Limertinib 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.

Surgical treatment after targeted therapy combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Peng Zhang, PhD

CONTACT

021-65115006; zhangpeng1121@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)