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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase

Enrolling

Phase 2

Conditions

EGFR-mutant Non-small Cell Lung Cancer

Potentially Resectable

Treatments

Drug: Sacituzumab Tirumotecan and Limertinib

Study type

Interventional

Funder types

Other

Identifiers

NCT07323056

LungMate-037

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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