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NCT Number: NCT07323056

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

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.

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Key information

Conditions

EGFR-Mutant Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Potentially Resectable Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pathological complete response (pCR) rate

    Time frame: Perioperative

Secondary outcomes

  1. Major pathologic response (MPR) rate

    Time frame: Perioperative

  2. Objective response rate (ORR)

    Time frame: Up to 3 months

  3. Event-free suvival (EFS)

    Time frame: Up to 60 months

  4. Overall suvival (OS)

    Time frame: Up to 60 months

  5. R0 resection rate

    Time frame: Perioperative

  6. Incidence of treatment discontinuation due to AE/SAE

    Time frame: Up to 3 months

  7. Treatment-related adverse event (TRAE)

    Time frame: Up to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Zhang, PhD

CONTACT

[email protected]

021-65115006

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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