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New treatment option for EGFR-mutant Non-small Cell Lung Cancer
Official title Neoadjuvant Sacituzumab Tirumotecan and Limertinib for Potentially Resectable Stage Ⅲ EGFR-mutant Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07323056
What this study is testing
What is Sacituzumab Tirumotecan and Limertinib?
Sacituzumab Tirumotecan and Limertinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for egfr-mutant non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign the informed consent form
- The age of the people 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...
- Have not received systematic anti-tumor treatment before
You likely can't join if
- 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
See the full eligibility criteria
- Sign the informed consent form
- The age of the people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.