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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07343479

Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases

A Phase 2 study testing sac-TMT plus EGFR-TKI in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR Gene Mutations, run by Zhejiang Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, open-label, multi-center, single-arm clinical trial Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
sac-TMT plus EGFR-TKI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 May 2026to 20 Dec 2029
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF), regardless of gender;
  • Histologically or cytologically confirmed non-squamous NSCLC, and metastatic (Stage IV);
  • Confirmed EGFR sensitizing mutation including exon 19 deletion (19-Del) or exon 21 point mutation (L858R);
  • Subject has previously received EGFR-TKI therapy for locally advanced or metastatic disease and has experienced radiological PD;
  • Subjects with new or previously diagnosed brain metastasis confirmed by contrast-enhanced cranial MRI;
  • ECOG performance status scale of 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • Adequate organ and bone marrow function;

Who cannot join

  • Tumor histology or cytology confirms combined small cell lung cancer (SCLC), neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma;
  • Known leptomeningeal metastases;
  • Other malignant tumors within 3 years prior to the first dose (except for tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, etc.);
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >470 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention;
  • Uncontrolled systemic diseases as judged by the investigators;
  • Clinically severe pulmonary impairment due to concurrent lung disorders, including but not limited to any underlying lung disorder (e.g., pulmonary embolism within 3 months before the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.), or prior pneumonectomy;
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  • Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage;
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease;
  • Active infection requiring systemic therapy;
  • Active hepatitis B [hepatitis B surface antigen (HBsAg) positive, requiring hepatitis B virus deoxyribonucleic acid (HBV-DNA) testing; HBV-DNA ≥500 IU/mL or above the lower limit of detection, whichever is higher] or hepatitis C [hepatitis C antibody positive, and hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection];
  • Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
  • History of allogeneic tissue/solid organ transplant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Li, Doctor contact

+8657188122092

lihui@zjcc.org.cn

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Li Hui, Doctor, 057188122092, lihui@zjcc.org.cn

Other trials in China

About this study

Official title: A Clinical Study of Sac-TMT for Injection Combined With Third-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) ± Radiotherapy in Subjects With EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer and Brain Metastasis Who Have Failed Prior EGFR-TKI Treatment

This is a prospective, open-label, multi-center, single-arm clinical trial

Read the detailed description

The purpose of this study is to assess the efficacy and safety of sac-TMT combined with third-generation EGFR-TKI with/without intracranial radiotherapy in subjects with EGFR-mutated NSCLC and brain metastasis who have failed prior EGFR-TKI treatment. Eligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.

Being tested
sac-TMT plus EGFR-TKI
Keywords
NSCLC with brain metastasis
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sac-TMT plus EGFR-TKIDrug

    Eligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.

Study groups in NCT07343479
Study groupRoleWhat they receive
sac-TMT plus EGFR-TKIExperimentalSacituzumab tirumotecan combined with third-generation EGFR-TKI with or without intracranial radiotherapy
Receives: Drug: sac-TMT plus EGFR-TKI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month PFS rate

    6-month PFS rate as assessed by the investigators according to RECIST v1.1.

    Measured: 6 months post treatment initiation date (maximum follow-up of 36 months)

Secondary outcomes (4)

  1. Overall ORR and DCR

    Overall ORR and DCR as assessed by the investigators according to RECIST v1.1

    Measured: From initiation of treatment to disease progression or death from any cause, whichever occurs first (maximum follow-up of 36 months)

  2. DOR

    DOR as assessed by the investigators according to RECIST v1.1

    Measured: From first disease response until tumor progression (maximum follow-up of 36 months).

  3. OS

    Time from treatment initiation to date of death due to any cause or last day of contact.

    Measured: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 36 months)

  4. Safety endpoints

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [based on the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI)]

    Measured: From first dose of study treatment until 30 days after the last dose, assessed up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion20 Dec 2029 (estimated)

Resources

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343479
Sponsor's protocol ID
IRB-2025-1523（IIT）
Status last verified
Jan 2026
First submitted
13 Dec 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sac-TMT plus EGFR-TKI in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR Gene Mutations, run by Zhejiang Cancer Hospital 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 12 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: opening soon, as of the sponsor's last update on 15 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 Hui Li, Doctor (+8657188122092, lihui@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month PFS rate (time frame: 6 months post treatment initiation date (maximum follow-up of 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07343479.

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 15 Jan 2026.

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