Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07323056

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

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-01-07

36

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Age over 18 years old
  • Diagnosed with non-small cell lung cancer with confirmed EGFR mutation by pathology
  • Locally advanced NSCLC (stage IIIA, IIIB, or IIIC) confirmed by chest CT, PET-CT, or EBUS, with MDT consensus that immediate surgery is not suitable
  • No prior systemic anti-tumor treatment
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Good lung function and able to tolerate surgery
  • ECOG performance status score of 0 to 1
Not Eligible

You will not qualify if you...

  • Allergy to sacituzumab tirumotecan or any excipients
  • Allergy to limertinib or any excipients
  • History of other primary tumors or allogeneic organ transplantation
  • Major surgery within 4 weeks before first dose (excluding diagnostic biopsy)
  • History of drug abuse, long-term alcohol abuse, AIDS, or HIV infection
  • Active or past autoimmune diseases that may recur
  • Current systemic hormone therapy equivalent to more than 10 mg prednisone daily or other immunosuppressive therapy within 14 days before first dose
  • Previous treatment with any EGFR-TKI or TROP2 ADC

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Pulmonary Hospital

Shanghai, China

Actively Recruiting

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Research Team

P

Peng Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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