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

ConditionsEGFR-mutant Non-small Cell Lung CancerPotentially Resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Surgical treatment after targeted therapy combined with chemotherapyExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov
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