NCT07323056 Neoadjuvant Sacituzumab Tirumotecan and Limertinib for Potentially Resectable Stage Ⅲ EGFR-mutant Non-small Cell Lung Cancer
| NCT ID | NCT07323056 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | EGFR-mutant Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2026-01-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07323056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying EGFR-mutant Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07323056 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07323056 currently recruiting?
Yes, NCT07323056 is actively recruiting participants. Contact the research team at zhangpeng1121@tongji.edu.cn for enrollment information.
Where is the NCT07323056 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07323056 clinical trial?
NCT07323056 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The trial plans to enroll 36 participants.
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