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Recruiting NCT07323056

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

Phase II Interventional EGFR-mutant Non-small Cell Lung Cancer Potentially Resectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacituzumab Tirumotecan and Limertinib.
Who it may be relevant to
Registry conditions: EGFR-mutant Non-small Cell Lung Cancer, Potentially Resectable. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 tre

Primary outcome measures

  • Pathological complete response (pCR) rate [Time frame: Perioperative]
Secondary outcome measures (7)
  • Major pathologic response (MPR) rate [Time frame: Perioperative]
  • Objective response rate (ORR) [Time frame: Up to 3 months]
  • Event-free suvival (EFS) [Time frame: Up to 60 months]
  • Overall suvival (OS) [Time frame: Up to 60 months]
  • R0 resection rate [Time frame: Perioperative]
  • Incidence of treatment discontinuation due to AE/SAE [Time frame: Up to 3 months]
  • Treatment-related adverse event (TRAE) [Time frame: Up to 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07323056 · LungMate-037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗