Neoadjuvant sacituzumab tirumotecan plus limertinib for potentially resectable stage III EGFR‑mutant non‑small cell lung cancer
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
This trial will test whether giving sacituzumab tirumotecan with limertinib before surgery can shrink stage III EGFR‑mutant non‑small cell lung cancers enough to allow safe resection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China Academic / other |
| Drugs / interventions | Sacituzumab, Limertinib, prednisone, lucetamab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07323056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with treatment‑naïve, pathologically confirmed EGFR‑mutant stage IIIA–IIIC NSCLC, ECOG 0–1, at least one measurable lesion, good lung function, and deemed not immediately operable but potentially convertible to surgery.
Not a fit: Patients with metastatic disease beyond stage III, prior systemic therapy, poor performance status (ECOG ≥2), active other malignancies, or allergies to the study drugs are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the approach could increase the number of patients with stage III EGFR‑mutant lung cancer who can have curative surgery and potentially improve long‑term outcomes.
How similar studies have performed: EGFR tyrosine kinase inhibitors alone have shown benefit as neoadjuvant or conversion therapy in EGFR‑mutant NSCLC, but combining an antibody–drug conjugate like sacituzumab tirumotecan with an EGFR TKI in this setting is experimental with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Peng Zhang, PhD
- Email: zhangpeng1121@tongji.edu.cn
- Phone: 021-65115006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.