EGFR-mutant Non-small Cell Lung CancerPhase 2NCT07323056
Neoadjuvant Sacituzumab Tirumotecan and Limertinib for Potentially Resectable Stage Ⅲ EGFR-mutant Non-small Cell Lung Cancer
A Phase 2 study testing Sacituzumab Tirumotecan and Limertinib in people with EGFR-mutant Non-small Cell Lung Cancer and Potentially Resectable, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR-mutant Non-small Cell Lung Cancer, Potentially Resectable
- What is being tested?
- Sacituzumab Tirumotecan and Limertinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Peng Zhang, PhD, 021-65115006, zhangpeng1121@tongji.edu.cn
About this study
Official title: 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 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.
- Being tested
- Sacituzumab Tirumotecan and Limertinib
- Keywords
- non-small cell lung cancer, EGFR-mutant, Sacituzumab Tirumotecan, Limertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan and LimertinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment after targeted therapy combined with chemotherapy | Experimental | Not described Receives: Drug: Sacituzumab Tirumotecan and Limertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Measured: Perioperative
Secondary outcomes (7)
Major pathologic response (MPR) rate
Measured: Perioperative
Objective response rate (ORR)
Measured: Up to 3 months
Event-free suvival (EFS)
Measured: Up to 60 months
Overall suvival (OS)
Measured: Up to 60 months
R0 resection rate
Measured: Perioperative
Incidence of treatment discontinuation due to AE/SAE
Measured: Up to 3 months
Treatment-related adverse event (TRAE)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-mutant Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323056
- Sponsor's protocol ID
- LungMate-037
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07323056
- Acronym / sponsor ID
- LungMate-037
- Keywords
- non-small cell lung cancer, EGFR-mutant, Sacituzumab Tirumotecan, Limertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment after targeted therapy combined with chemotherapy | Experimental | Drug: Sacituzumab Tirumotecan and Limertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Tirumotecan and LimertinibSacituzumab 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. | Drug | Surgical treatment after targeted therapy combined with chemotherapy |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Perioperative
7 secondary outcomes
Major pathologic response (MPR) rate
Time frame: Perioperative
Objective response rate (ORR)
Time frame: Up to 3 months
Event-free suvival (EFS)
Time frame: Up to 60 months
Overall suvival (OS)
Time frame: Up to 60 months
R0 resection rate
Time frame: Perioperative
Incidence of treatment discontinuation due to AE/SAE
Time frame: Up to 3 months
Treatment-related adverse event (TRAE)
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan and Limertinib in people with EGFR-mutant Non-small Cell Lung Cancer and Potentially Resectable, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhang, PhD (021-65115006, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.