Neoadjuvant sacituzumab tirumotecan plus limertinib for potentially resectable stage III EGFR‑mutant non‑small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm phase 2 trial testing a neoadjuvant combination of sacituzumab tirumotecan and limertinib in patients with locally advanced, potentially resectable EGFR‑mutant NSCLC. Participants who are treatment‑naïve will receive the drug combination and be monitored with imaging and RECIST 1.1 to measure tumor response and conversion to resectability. Safety and tolerability will be recorded, and patients judged convertible may proceed to surgery, with perioperative outcomes tracked. The study will also explore biomarkers that might predict which patients benefit from the combination.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Pulmonary Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Peng Zhang, PhD
• Email: zhangpeng1121@tongji.edu.cn
• Phone: 021-65115006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.